Effects of benzalkonium chloride- or polyquad-preserved fixed combination glaucoma medications on human trabecular meshwork cells.

PubMed

Ammar, David A; Kahook, Malik Y

2011-01-01

We investigated the potential short and long-term effects in cultured human trabecular meshwork (TM) cells of various topical glaucoma formulations containing different preservatives. We tested the fixed combination medications 0.004% travoprost plus 0.5% timolol preserved with either 0.015% benzalkonium chloride (BAK; DuoTrav®), or with 0.001% polyquad (PQ; DuoTrav(®) BAK-free); and 0.005% latanoprost plus 0.5% timolol preserved with 0.020% BAK (Xalacom(®)). Also tested was a range of BAK concentrations (0.001%-0.020%) in balanced salt solution (BSS). Cells were treated for 25 min at 37 °C with solutions diluted 1:10 and 1:100 to mimic the reduced penetration of topical preparations to the anterior chamber. The percentage of live cells was determined immediately after treatment through the uptake of the fluorescent vital dye calcein-AM. To determine any long-term effects, we assayed release of matrix metalloproteinase 9 (MMP-9) and apoptosis 24 h after treatments. BAK demonstrated a dose-dependent reduction in TM cell viability, ranging from 71±5% live cells at 0.001% BAK (diluted 1:10) to 33±3% live cells at 0.020% BAK (diluted 1:10). Travoprost (0.004%) plus 0.5% timolol preserved with 0.015% BAK had statistically fewer live TM cells (79±7%) than the same preparation preserved with 0.001% polyquad® (PQ; 93±1%; p<0.001). Latanoprost plus timolol preserved with 0.020% BAK (29±9% live cells) was similar to the 0.020% BAK (33±3%) treatment. However, travoprost plus timolol preserved in 0.015% BAK had significantly more live cells (83±12%) than the 1:10 dilution of 0.015% BAK (49±10%). We also found 0.020% BAK (diluted 1:100) resulted in elevated levels of extracellular MMP-9 at 24 h. These results demonstrate that the substitution of the preservative BAK from topical ophthalmic drugs results in greater in vitro viability of TM cells. Travoprost with timolol, but not latanoprost with timolol, countered some of the toxic BAK effects. BAK treatment appeared to cause elevated levels of MMP-9, a matrix metalloproteinase implicated in the pathogenesis of glaucoma. © 2011 Molecular Vision

Comparative cost evaluation of brand name and generic ophthalmology medications in Ontario.

PubMed

Popovic, Marko; Chan, Clara; Lattanzio, Nisha; El-Defrawy, Sherif; Schlenker, Matthew B

2018-04-01

Medication cost for the same indication can vary considerably and can affect patient compliance. In this comparative cost analysis of commonly prescribed ophthalmology medications, the differences in cost between generic and brand name medications as well as different medications within an individual drug class were evaluated. Eye preparations from the Ontario Drug Benefit Formulary were identified, and further agents commonly prescribed by ophthalmologists were included. The standardized prescription drug cost, which includes the cost of the medication, mark-up, and dispensing cost, was provided by Ontario Shoppers Drug Mart stores in July 2016 for 103 common medications using typical dosages and durations. Based on medication class, the highest and lowest cost medications were antiallergy agents (Zaditor [ketotifen], Vasocon [naphazoline]), antibiotic ophthalmic solutions (Vigamox [moxifloxacin], generic ciprofloxacin), oral antibiotics (Cipro [ciprofloxacin], generic cephalexin), antibiotic ophthalmic ointments (generic erythromycin, Tobrex [tobramycin]), antiviral treatment (Valtrex [oral valacyclovir], Viroptic [topical trifluridine]), blepharitis treatment (Zithromax [oral azithromycin], generic oral tetracycline), beta-adrenergic inhibitors (Timoptic [topical timolol], generic topical timolol), topical prostaglandin analogues (Xalatan [latanoprost], generic travoprost), oral carbonic anhydrase inhibitors (methazolamide, acetazolamide), topical carbonic anhydrase solutions (Trusopt preservative-free [dorzolamide], Azopt [brinzolamide]), topical alpha-adrenergic agonists (Alphagan [brimonidine], generic brimonidine), topical muscarinic agonists (Isopto carpine [pilocarpine], Diocarpine [pilocarpine]), topical combination glaucoma agents (Cosopt [dorzolamide-timolol], generic dorzolamide-timolol), topical lubricants (Lacri-lube, Isopto tears), topical nonsteroidal anti-inflammatory drugs (Acuvail [ketorolac], Ilevro [nepafenac]), and steroids (Durezol [difluprednate], Pred mild [prednisolone]). Substantial cost differences exist between ophthalmology medications of the same class. We encourage ophthalmologists to be aware of the associated costs of the medications they prescribe and to use this information in their decision making. Copyright © 2018 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.

The Effect of Rebamipide on Ocular Surface Disorders Induced by Latanoprost and Timolol in Glaucoma Patients.

PubMed

Tokuda, Naoto; Kitaoka, Yasushi; Matsuzawa, Akiko; Miyamoto, Junsuke; Sakae, Shinsuke; Munemasa, Yasunari; Takagi, Hitoshi

2015-01-01

Purpose. To examine the efficacy of ophthalmic rebamipide suspensions on ocular surface disorders induced by antiglaucoma eye drops. Patients and Methods. Forty eyes of 40 patients receiving latanoprost (0.005%) and timolol (0.5%) were included in this randomized prospective study. The patients were randomly divided into two groups (n = 20): the rebamipide-treated group and control group. Changes in intraocular pressure, tear film break-up time (TBUT), and corneal epithelial barrier function were evaluated at baseline, 4 weeks, and 8 weeks after rebamipide administration. Furthermore, superficial punctate keratopathy severity was evaluated by scoring the lesion area and density. Results. There was no significant difference in intraocular pressure before and after rebamipide treatment. However, corneal epithelial barrier function improved significantly 4 and 8 weeks after rebamipide treatment. TBUT was partially, but significantly, increased (P = 0.02) 8 weeks after rebamipide treatment, whereas no significant change was observed at 4 weeks. Additionally, a significant decrease in area and density of keratopathy was observed 8 weeks after rebamipide treatment but not at 4 weeks. The control group showed no significant difference compared to baseline. Conclusions. Our data suggests that rebamipide treatment may reduce the occurrence of drug-induced ocular surface disorder.

In vivo performance of a drug-eluting contact lens to treat glaucoma for a month

PubMed Central

Ciolino, Joseph B.; Stefanescu, Cristina F.; Ross, Amy E.; Salvador-Culla, Borja; Cortez, Priscila; Ford, Eden M.; Wymbs, Kate A.; Sprague, Sarah L.; Mascoop, Daniel R.; Rudina, Shireen S.; Trauger, Sunia A.; Cade, Fabiano; Kohane, Daniel S.

2013-01-01

For nearly half a century, contact lenses have been proposed as a means of ocular drug delivery, but achieving controlled drug release has been a significant challenge. We have developed a drug-eluting contact lens designed for prolonged delivery of latanoprost for the treatment of glaucoma, the leading cause of irreversible blindness worldwide. Latanoprost-eluting contact lenses were created by encapsulating latanoprost–poly(lactic-co-glycolic acid) films in methafilcon by ultraviolet light polymerization. In vitro and in vivo studies showed an early burst of drug release followed by sustained release for one month. Contact lenses containing thicker drug–polymer films demonstrated released a greater amount of drug after the initial burst. In vivo, single contact lenses were able to achieve, for at least one month, latanoprost concentrations in the aqueous humor that were comparable to those achieved with topical latanoprost solution, the current first-line treatment for glaucoma. The lenses appeared safe in cell culture and animal studies. This contact lens design can potentially be used as a treatment for glaucoma and as a platform for other ocular drug delivery applications. PMID:24094935

Combined therapy for resistant vitiligo lesions: NB-UVB, microneedling, and topical latanoprost, showed no enhanced efficacy compared to topical latanoprost and NB-UVB.

PubMed

Stanimirovic, Andrija; Kovacevic, Maja; Korobko, Igor; Šitum, Mirna; Lotti, Torello

2016-09-01

Vitiligo is depigmenting disorder of the skin and mucous membranes but despite various therapeutic options, complete and satisfactory treatment of vitiligo still remains a challenge. Therapeutic success also varies depending on the localization of lesions; hands and bony prominents are considered to be resistant to treatment. We investigated feasibility of treating resistant bilateral symmetrical vitiligo vulgaris and acrofacialis lesions with combination of narrowband UVB and topical prostaglandins (0.005% latanoprost solution) with or without Dermaroller 0.5 mm needle length-assisted microneedling. Frequency of repigmentation onset was generally low (37.8%) and pronounced repigmentation was infrequently seen (26-50% repigmentation in 20.8%, and >50% repigmentation in only 8.8% of repigmenting lesions). Our study, however, showed that latanoprost can be used in combination with NB-UVB phototherapy to induce repigmentation in some vitiligo lesions in resistant-to-treatment location, while addition of skin microneedling seems not to improve the treatment outcome and possibly needs modification. © 2016 Wiley Periodicals, Inc.

[Pharmacological profiles of latanoprost (Xalatan), a novel anti-glaucoma drug].

PubMed

Nomura, S; Hashimoto, M

2000-05-01

Latanoprost is a novel prostaglandin F2 alpha (PGF2 alpha) derivative. Topically applied latanoprost into the glaucomatous monkey eyes lowered intraocular pressure (IOP). Latanoprost, however, failed to produce the hypotensive effect in either rabbit or cat eyes. This species difference may be attributed to its high selectivity for the FP receptor and differences in prostaglandin receptor subtypes existed in the eye amongst these species. In ligand binding studies with bovine corpus luteum cell membranes, the Kd value for the FP receptor of latanoprost was the same as that for PGF2 alpha, 2.8 nM. Latanoprost augmented uveoscleral outflow (Uv) in monkeys without affecting trabecular outflow or outflow facility like PGF2 alpha. Although the precise mechanism of the increase in Uv is not fully understood, it is suggested that a decrease in extracellular matrix components in ciliary muscle may contribute to the increase in Uv. On the other hand, an increase in blood flow at the optic nerve head and neuroprotective action in addition to the IOP lowering effect may contribute to the efficacy of latanoprost in glaucoma therapy. Only tolerable conjunctival hyperemia was seen in rabbits. A phase III clinical trial revealed latanoprost (0.005%) once daily produced sustained reduction of IOP in ocular hypertension or primary open-angle glaucoma patients to a greater extent than timolol did. Furthermore, the effects of latanoprost on aqueous humor dynamics in normal human volunteers were similar to those in monkeys, indicating that latanoprost lowers IOP by the increase in Uv in humans.

Effect of ophthalmic solution components on acrylic intraocular lenses.

PubMed

Ayaki, Masahiko; Nishihara, Hitoshi; Yaguchi, Shigeo; Koide, Ryohei

2007-01-01

To investigate the effect of ophthalmic solution components on the surface of acrylic intraocular lenses (IOLs). Department of Opthalmology, Showa University School of Medicine. Measurement of the contact angles of ophthalmic solutions on 3 acrylic IOLs was performed. The solutions were diclofenac sodium (Diclod), bromfenac sodium (Bronuck), betamethasone phosphate (Rinderon), dibekacin sulfate (Panimycin), polysorbate 80 (Tween 20), benzalkonium chloride, chlorobutanol, methylparahydroxybenzoate, and propylparahydroxybenzoate. The IOLs were incubated at 35 degrees C for 2 weeks in undiluted ophthalmic solutions and in 1:10 dilutions of ophthalmic solution components. The IOLs were sectioned and observed by scanning electron microscopy. The contact angle of Diclod and Bronuck solutions was the smallest. The contact angle of Rinderon and Panimycin was similar to that of distilled water. Scanning electron microscopy examination of IOLs incubated in ophthalmic solution components showed intralenticular changes. The IOLs immersed in ophthalmic solutions did not show any change, even after extended incubation. The chemical components of ophthalmic solutions, such as surfactants and solvents, permeate acrylic IOLs, suggesting the potential for long-term adverse effects of eyedrops in pseudophakic eyes.

A randomized double-blind placebo-controlled pilot study to assess the efficacy of a 24-week topical treatment by latanoprost 0.1% on hair growth and pigmentation in healthy volunteers with androgenetic alopecia.

PubMed

Blume-Peytavi, Ulrike; Lönnfors, Sanna; Hillmann, Kathrin; Garcia Bartels, Natalie

2012-05-01

Latanoprost is a prostaglandin analogue used to treat glaucoma. It can cause adverse effects, such as iridial and periocular hyperpigmentation, and eyelash changes including pigmentation and increased thickness, length, and number. Latanoprost has been used to treat eyelash alopecia, but knowledge on its effects on human scalp hair growth is not available. The primary objectives were to assess the efficacy of latanoprost on hair growth and pigmentation. The secondary objectives were to assess the effect on scalp pigmentation; investigate the treatment duration needed to affect hair growth, hair pigmentation, and scalp pigmentation; and assess safety of latanoprost. Sixteen men with mild androgenetic alopecia (Hamilton II-III) were included. Latanoprost 0.1% and placebo were applied daily for 24 weeks on two minizones on the scalp. Measurements on hair growth, density, diameter, pigmentation, and anagen/telogen ratio were performed throughout the study. At 24 weeks, an increased hair density on the latanoprost-treated site was observed compared with baseline (n = 16, P < .001) and placebo-treated site (P = .0004). Only young men with mild androgenetic alopecia were included. The results may not be applicable to other patient groups. Choice of investigational site may have affected the results. Latanoprost significantly increased hair density (terminal and vellus hairs) at 24 weeks compared with baseline and the placebo-treated area. Latanoprost could be useful in stimulating hair follicle activity and treating hair loss. Copyright © 2011 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

Diquafosol ophthalmic solution 3 %: a review of its use in dry eye.

PubMed

Keating, Gillian M

2015-05-01

Diquafosol ophthalmic solution 3 % (Diquas(®)) is a P2Y2 receptor agonist that promotes tear fluid and mucin secretion and is currently approved in Japan and South Korea for the treatment of dry eye. In randomized, double-blind, multicentre trials in patients with dry eye, significantly greater improvements in fluorescein and rose bengal staining scores were seen with diquafosol ophthalmic solution 3 % than with placebo, and diquafosol ophthalmic solution 3 % was noninferior to sodium hyaluronate ophthalmic solution 0.1 % in terms of the improvement in the fluorescein staining score and more effective than sodium hyaluronate ophthalmic solution 0.1 % in terms of the improvement in the rose bengal staining score. The efficacy of diquafosol ophthalmic solution 3 % in the treatment of dry eye was maintained in the longer term, with improvements also seen in subjective dry eye symptoms, and was also shown in a real-world setting. Diquafosol ophthalmic solution 3 % also demonstrated efficacy in various specific dry eye disorders, including aqueous-deficient dry eye, short tear film break-up time dry eye, obstructive meibomian gland dysfunction, dry eye following laser in situ keratomileusis surgery and dry eye following cataract surgery, as well as in contact lens wearers and visual display terminal users. Diquafosol ophthalmic solution 3 % was generally well tolerated in patients with dry eye, with eye irritation the most commonly reported adverse event. In conclusion, diquafosol ophthalmic solution 3 % is a useful option for the treatment of dry eye.

[Pressure-reducing effect of latanoprost 0.005%].

PubMed

Albach, C; Wachsmuth, E D; Velte, K; Dekker, P; Robert, Y

1998-05-01

Earlier studies in monkeys have shown that latanoprost 0.005% lowers the IOP by improving the uveoscleral Outflow. We wanted to know if this is also the case in the human eye. We used our new aqueous humor outflow test with 2-nitrophenyl-acetate in 9 healthy human volunteers, mean age 32 +/- 8.3 years. They were measured before and 12 h after receiving one drop of latanoprost 0.005% in one eye, randomly chosen. The ocular Photometer was used to quantify the disappearance of the dye out of the anterior chamber. The half-life time of the dye is shortened after latanoprost 0.005%. It is significantly correlated to the pressure lowering effect of latanoprost 0.005% (r2 = 0.5968). The dye-dilution technique proves that latanoprost 0.005% influences the outflow of the human eye. The better the outflow, the greater the pressure drop in the eye. The experiment nicely shows that photometric quantification of 2-nitrophenyl-acetate is a simple, reliable test for the knowledge of the aqueous humor outflow.

A randomised crossover study comparing bimatoprost and latanoprost in subjects with primary angle closure glaucoma.

PubMed

How, A C S; Kumar, R S; Chen, Y-M; Su, D H; Gao, H; Oen, F T; Ho, C-L; Seah, S K; Aung, T

2009-06-01

To compare the intraocular pressure (IOP) lowering efficacy and side effects of latanoprost 0.005% and bimatoprost 0.03% in subjects with chronic primary angle closure glaucoma (PACG). This was an observer-masked randomised crossover study of 60 PACG subjects who received either latanoprost or bimatoprost for 6 weeks, after which they were crossed over to the other medication for another 6 weeks. The IOP-reducing effect of the medications was assessed by the reduction in IOP after 6 weeks of treatment compared with baseline. Fifty-four subjects (80 eyes) completed the study. Latanoprost reduced IOP (mean (SD)) by 8.4 (3.8) mm Hg and bimatoprost by 8.9 (3.9) mm Hg from a baseline of 25.2 (3.6) mm Hg and 25.2 (3.6) mm Hg respectively (p = 0.23). Adverse events were mild in both groups; however there were twice as many reports of an adverse event in the bimatoprost group (81%) compared with the latanoprost group (40%, p<0.01). Ocular irritation was the most frequently reported adverse event in both groups; 22 subjects (37.9%) treated with bimatoprost experienced ocular hyperaemia as compared with 13 subjects (22.4%) treated with latanoprost (p = 0.11). Bimatoprost once daily was similarly effective in reducing IOP compared with latanoprost once daily in subjects with chronic PACG. Both drugs were well tolerated with mild ocular adverse events.

Projected impact of travoprost versus both timolol and latanoprost on visual field deficit progression and costs among black glaucoma subjects.

PubMed Central

Halpern, Michael T; Covert, David W; Robin, Alan L

2002-01-01

PURPOSE: We compared differences associated with use of travoprost and latanoprost on both progression of perimetric loss over time and associated costs among black patients. METHODS: Patients with primary open-angle glaucome or ocular hypertension were randomly assigned to one of four arms in a 12-month, double-masked study: travoprost (0.004% or 0.0015%), latanoprost (0.005%), or timolol (0.5%). Forty-nine patients received 0.004% travoprost, 43 received latanoprost, and 40 received timolol. We applied algorithms found in published studies that link intraocular pressure (IOP) control to visual field progression and calculated the likelihood of visual field deterioration based on IOP data. This was used to estimate differences in medical care costs. RESULTS: The average IOP was lower for patients receiving travoprost than for patients receiving latanoprost or timolol (17.3 versus 18.7 versus 20.5 mm Hg respectively, P < .05). Travoprost-treated patients had a smaller predicted change in visual field defect score (VFDS) than latanoprost-treated patients and timolol-treated patients, and significantly fewer were expected to demonstrate visual field progression. Medical care costs would be higher for latanoprost-treated and timolol-treated patients. CONCLUSIONS: Recent studies have provided algorithms linking IOP control to changes in visual fields. We found that treatment with travoprost was associated with less visual field progression and potential cost savings. PMID:12545683

The effect of topically administered latanoprost on the cochlear blood flow and hearing.

PubMed

Jang, Chul Ho; Cho, Yong Beom; Choi, Cheol Hee; Um, Jae-Young; Wang, Pa-Chun; Pak, Sok Cheon

2013-06-01

The application of intratympanic latanoprost (PGF2α analog) has been recently used to alleviate vertigo, disequilibrium and to improve hearing in Meniere's disease patients. However, there is no known report on the effect of topically applied latanoprost on hearing and cochlear hemodynamic parameters including cochlear blood flow (CBF) and vascular conductance. Our goal was to assess the influence of topically applied latanoprost on cochlear blood flow (CBF) and hearing. Twenty male Sprague-Dawley rats were randomly divided into the group A, 50 μl of latanoprost (1 ml containing 50 μg, n=10) and group B, 100 μl (1 ml containing 50 μg, n=10). Topical application of latanoprost was performed at the right side, and the left side was applied with phosphate buffered saline (PBS) as a negative control. Five rats at each group were used to measure cochlear blood flow (CBF). And the others at each group were used for hearing test by auditory brainstem response (ABR). After physiological examination, bullas were extracted. The changes of cochlear hair cells were observed by performing the field emission-scanning electron microscopy (FE-SEM). The CBF of both groups was found to be decreased compared to the PBS applied left side. Significant decrement of CBF was observed in group B compared to the group A. Significant elevation of hearing threshold at high frequencies was observed in both groups compared to the PBS applied group. However, inner and outer hair cells were intact. Topically administered latanoprost decreased the CBF and impaired hearing. Based on our findings, additional studies are required to evaluate the side effects of intratympanic latanoprost before its use in clinical practice. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Effects of Topical Latanoprost on Intraocular Pressure and Myopia Progression in Young Guinea Pigs

PubMed Central

El-Nimri, Nevin W.; Wildsoet, Christine F.

2018-01-01

Purpose To determine whether latanoprost, a prostaglandin analog proven to be very effective in reducing intraocular pressure (IOP) in humans, can also slow myopia progression in the guinea pig form deprivation (FD) model. Methods Two-week-old pigmented guinea pigs underwent monocular FD and daily topical latanoprost (0.005%, n = 10) or artificial tears (control, n = 10) starting 1 week after the initiation of FD, with all treatments continuing for a further 9 weeks. Tonometry, retinoscopy, and high-frequency A-scan ultrasonography were used to monitor IOP, refractive error, and ocular axial dimensions, respectively. Results Latanoprost significantly reduced IOP and slowed myopia progression. Mean interocular IOP differences (±SEM) recorded at baseline and week 10 were −0.30 ± 0.51 and 1.80 ± 1.16 mm Hg (P = 0.525) for the control group and 0.07 ± 0.35 and −5.17 ± 0.96 mm Hg (P < 0.001) for the latanoprost group. Equivalent interocular differences for optical axial length at baseline and week 10 were 0.00 ± 0.015 and 0.29 ± 0.04 mm (P < 0.001; control) and 0.02 ± 0.02 and 0.06 ± 0.02 mm (P = 0.202; latanoprost), and for refractive error were +0.025 ± 0.36 and −8.2 ± 0.71 diopter (D) (P < 0.001; control), and −0.15 ± 0.35 and −2.25 ± 0.54 D (P = 0.03; latanoprost). Conclusions In the FD guinea pig model, latanoprost significantly reduces the development of myopia. Although further investigations into underlying mechanisms are needed, the results open the exciting possibility of a new line of myopia control therapy. PMID:29847673

[Optimization of benzalkonium chloride concentration in 0.0015% tafluprost ophthalmic solution from the points of ocular surface safety and preservative efficacy].

PubMed

Asada, Hiroyuki; Takaoka-Shichijo, Yuko; Nakamura, Masatsugu; Kimura, Akio

2010-06-01

Optimization of benzalkonium chloride (alkyl dimethylbenzylammonium chloride: BAK) concentration as preservative in 0.0015% tafluprost ophthalmic solution (Tapros 0.0015% ophthalmic solution), an anti-glaucoma medicine, was examined from the points of ocular surface safety and preservative efficacy. BAKC(12), which is dodecyl dimethylbenzylammonium chloride, and BAKmix, which is the mixture of dodecyl, tetradecyl and hexadecyl dimethylbenzylammonium chloride were used in this study. The effects of BAKC(12) concentrations and the BAK types, BAKC(12) and BAKmix, in tafluprost ophthalmic solution on ocular surface safety were evaluated using the in vitro SV 40-immobilized human corneal epithelium cell line (HCE-T). Following treatments of Tafluprost ophthalmic solutions with BAKC(12), its concentration dependency was observed on cell viability of HCE-T. The cell viability of HCE-T after treatment of these solutions with 0.001% to 0.003% BAKC(12) for 5 minutes were the same level as that after treatment of the solution without BAK. Tafluprost ophthalmic solution with 0.01% BAKC(12) was safer for the ocular surface than the same solution with 0.01% BAKmix. Preservatives-effectiveness tests of tafluprost ophthalmic solutions with various concentrations of BAKC(12) were performed according to the Japanese Pharmacopoeia (JP), and solutions with more than 0.0005% BAKC(12) conformed to JP criteria. It was concluded that 0.0005% to 0.003% of BAKC(12) in tafluprost ophthalmic solution was optimal, namely, well-balanced from the points of ocular surface safety and preservative efficacy.

Medication adherence and health care costs with the introduction of latanoprost therapy for glaucoma in a Medicare managed care population.

PubMed

Bhosle, Monali J; Reardon, Gregory; Camacho, Fabian T; Anderson, Roger T; Balkrishnan, Rajesh

2007-06-01

Latanoprost, a prostaglandin inhibitor, is increasingly being used in the therapeutic management of glaucoma. However, there is scant literature examining the cost and outcome ramifications of latanoprost. This study examined the medication use behavior (medication-related persistence and adherence rates) and costs associated with the introduction of latanoprost therapy in a treatment-naive older population (aged >or=65 years) enrolled in Medicare. The study employed a retrospective observational cohort design and used administrative claims data from a Medicare health maintenance organization (HMO), which offered complete coverage to enrollees, including prescription benefits. The case group consisted of patients with glaucoma who began latanoprost therapy. The control group consisted of enrollees with glaucoma who started any therapy other than latanoprost. Both groups were followed up for 1 year before and after initiation of therapy. Bivariate and multivariate techniques incorporating health care utilization in the year before the start of new therapy were used to determine the study outcomes. The case group comprised 101 patients (mean age, 77.60 years), while the control group included 168 patients (mean age, 77.59 years). There were no significant differences across the 2 groups with respect to age, sex, general health scores on the 12 item Short-Form Health Survey, severity of comorbidity, or the proportion of respondents with perception of worsened health. Introduction of latanoprost therapy was associated with higher medication persistence (hazard ratio, 0.90; 95% CI, 0.68-0.98) and adherence rates (mean [SD], 0.51 [0.26] vs 0.40 [0.25]; P < 0.001) compared with patients starting other glaucoma medication. Furthermore, there were no additional increases in total health care costs in the entire population associated with the introduction of latanoprost therapy, after adjusting for group and time effects, as well as other confounders (mean [SD], $4718.24 [$8982.92] vs $4046.55 [$6505.39]). Latanoprost therapy offered improved medication use behavior in these older adults enrolled in a Medicare HMO. There were no significant additional increases in overall health care costs as a result of introduction of latanoprost therapy, after adjusting for group and time effects, as well as other baseline confounders in this study cohort.

Basics of Sterile Compounding: Ophthalmic Preparations, Part 2: Suspensions and Ointments.

PubMed

Allen, Loyd V

2016-01-01

Ophthalmic preparations are used to treat allergies, bacterial and viral infections, glaucoma, and numerous other eye conditions. When the eye's natural defensive mechanisms are compromised or overcome, an ophthalmic preparation, in a solution, suspension, or ointment form, may be indicated, with solutions being the most common form used to deliver a drug to the eye. This article discusses ophthalmic suspensions and ointments and represents part 2 of a 2-part article, the first of which discussed ophthalmic solutions. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

A 4-week, dose-ranging study comparing the efficacy, safety and tolerability of latanoprost 75, 100 and 125 μg/mL to latanoprost 50 μg/mL (xalatan) in the treatment of primary open-angle glaucoma and ocular hypertension

PubMed Central

2012-01-01

Background Several studies have investigated the effect of latanoprost on intraocular pressure (IOP). We compared the IOP-lowering effects of three higher concentrations of latanoprost with the commercially available concentration of 0.005% (50 μg/mL) in patients with primary open-angle glaucoma or ocular hypertension. Methods Treatment-naive subjects or those receiving IOP-lowering medication with baseline IOP levels of ≥24 mmHg and ≤36 mmHg in at least one eye after washout were randomized to receive an evening dose of latanoprost 50, 75, 100, or 125 μg/mL for 4 weeks. At weeks 1, 2, 3, and 4, ocular examinations were performed and IOP was measured. Ocular symptoms and adverse events were monitored. The primary efficacy endpoint was the change in IOP from baseline to week 4 at 8 a.m. and 4 p.m. for the per protocol (PP) population using a "worse eye" analysis. Secondary efficacy endpoints were change in IOP at each time point from baseline across all visits, and percentage change in IOP from baseline to week 4 at 8 a.m. Results In all, 282 patients were randomized and treated; 274 were included in the PP population. Treatment groups were similar at baseline; 68% were diagnosed with primary open-angle glaucoma. Mean baseline IOP levels were comparable across treatments. There were no statistically significant differences in IOP reductions from baseline to week 4 at either time point between those treated with higher concentrations of latanoprost versus those receiving 50 μg/mL. Least squares mean IOP changes at 8 a.m. were −10.13, -9.59, -10.02, and −9.06 mmHg for latanoprost 50, 75, 100, and 125 μg/mL, respectively, and at 4 p.m. were −8.90, -8.29, -8.81, and −8.34 mmHg, respectively. Results of secondary efficacy analyses supported those of the primary analysis. Conjunctival hyperemia, the most commonly reported adverse event, occurred in 16.9%, 18.6%, 20.8% and 15.9% of subjects receiving latanoprost 50, 75, 100, and 125 μg/mL, respectively. Conclusions IOP reductions were observed in all treatment groups postbaseline, with no clinically relevant or statistically significant differences detected favoring any of the higher concentrations of latanoprost compared with latanoprost 50 μg/mL. All doses of latanoprost were well tolerated. Trial registration Clinical Trials.gov Identifier NCT01379144. PMID:22607109

Preservative-free versus preserved latanoprost eye drops in patients with open-angle glaucoma or ocular hypertension.

PubMed

Aptel, Florent; Choudhry, Reena; Stalmans, Ingeborg

2016-08-01

This study compared the efficacy, safety, and pharmacokinetics of a preservative-free latanoprost formulation to an established, benzalkonium chloride (BAK) containing formulation for the treatment of open-angle glaucoma or ocular hypertension. This was a phase II, randomized, cross-over, investigator-masked, multi-center, pilot study (NCT01494753). A total of 30 untreated adult patients (aged ≥18 years) with primary open angle glaucoma, pseudo-exfoliative glaucoma, pigmentary glaucoma, or ocular hypertension received either preservative-free or preserved latanoprost once daily in both eyes for 6 weeks, before crossing over to receive the other treatment. Efficacy (intraocular pressure [IOP] at 8 am, midday, 4 pm and 8 pm, and global efficacy assessment by investigator), safety (adverse events, ocular symptoms and global tolerance, slit lamp examination, funduscopy, visual field examination, visual acuity, and heart rate), and pharmacokinetics were assessed at Days 0, 42, and 84. Both treatments resulted in a reduction in IOP that was similar for the preservative-free and the preserved formulation at all time points. Similarly, the overall diurnal reduction was similar in both groups (6.3 mmHg [27.9% reduction] and 6.4 mmHg [28.1% reduction] for preserved and preservative-free latanoprost, respectively). There were no differences in global efficacy assessment or in the safety and tolerance of each treatment. Systemic concentrations of latanoprost were very low; AUC0-30 and Cmax were lower and tmax was longer for preservative-free latanoprost. Preservative-free latanoprost showed similar efficacy at all time points compared to BAK preservative containing formulation, with no difference in tolerance, allowing progression to phase III clinical development.

24-Hour Efficacy and Ocular Surface Health with Preservative-Free Tafluprost Alone and in Conjunction with Preservative-Free Dorzolamide/Timolol Fixed Combination in Open-Angle Glaucoma Patients Insufficiently Controlled with Preserved Latanoprost Monotherapy.

PubMed

Konstas, Anastasios-Georgios; Boboridis, Konstadinos G; Kapis, Paraskevas; Marinopoulos, Konstantinos; Voudouragkaki, Irini C; Panayiotou, Dimitrios; Mikropoulos, Dimitrios G; Pagkalidou, Eirini; Haidich, Anna-Bettina; Katsanos, Andreas; Quaranta, Luciano

2017-01-01

The aim of the present study was to evaluate the 24-h efficacy, tolerability, and ocular surface health with preservative-free (PF) tafluprost and a PF triple drug regimen comprising tafluprost and dorzolamide/timolol fixed combination (DTFC) in open-angle glaucoma patients who were insufficiently controlled with preserved branded or generic latanoprost monotherapy and who exhibited signs or symptoms of ocular surface disease (OSD). Prospective, observer-masked, crossover, comparison. Eligible consecutive open-angle glaucoma patients were randomized to either PF tafluprost or the triple PF regimen for 3 months. They were then crossed over to the opposite therapy for another 3 months. At the end of the latanoprost run-in period and after each PF treatment period, patients underwent habitual 24-h intraocular pressure (IOP) monitoring with Goldmann tonometry in the sitting position (at 10:00, 14:00, 18:00, and 22:00) and Perkins tonometry in the supine position (at 02:00 and 06:00). Tolerability and selected ocular surface parameters were evaluated at baseline and the end of each treatment period. Forty-three open-angle glaucoma patients completed the trial. Mean 24-h IOP on preserved latanoprost was 22.2 ± 3.9 mmHg. Compared with latanoprost monotherapy, PF tafluprost obtained a greater reduction in mean, peak, and fluctuation of 24-h IOP including the 02:00 and 06:00 time points (P < 0.05). With the exception of 24-h fluctuation, the triple PF regimen provided significantly lower IOP parameters than latanoprost or PF tafluprost (P < 0.001). Finally, PF tafluprost therapy displayed significantly improved tear film break-up times (6.7 vs 6.0 s), corneal staining (1.3 vs 2.2), and Schirmer I test results (9.1 vs 8.2 mm) compared with the preserved latanoprost baseline (all P < 0.01). The triple PF regimen demonstrated similar tear film break-up times (6.1 vs 6.0 s) and Schirmer I test results (8.2 vs 8.2 mm) to latanoprost, but revealed a significant improvement in the corneal stain test (1.7 vs 2.2; P < 0.001). In this trial PF tafluprost therapy provided statistically greater 24-h efficacy and improved tolerability compared with preserved latanoprost. The combination of PF tafluprost and PF dorzolamide/timolol fixed combination was statistically and clinically more efficacious than both monotherapies and demonstrated similar ocular surface characteristics to preserved latanoprost monotherapy. ClinicalTrials.gov (NCT02802137). Santen.

Moxifloxacin Ophthalmic

MedlinePlus

Moxifloxacin ophthalmic solution is used to treat bacterial conjunctivitis (pink eye; infection of the membrane that covers the outside of the ... Moxifloxacin comes as an ophthalmic solution (liquid) to instill in the eyes. It is usually used three times a day for 7 days. Try to use at ...

A comparison of latanoprost monotherapy with a combination therapy of timolol/dorzolamide in patients with primary open-angle glaucoma.

PubMed

Caça, Ihsan; Simsek, Hüseyin; Unlü, Kaan; Ari, Seyhmus; Keklikçi, Ugur

2006-01-01

We compared latanoprost monotherapy therapy with timolol/ dorzolamide in patients with primary open-angle glaucoma to evaluate the effects on intraocular pressure (IOP) and occurrence of adverse events. IOP and topical side effects were evaluated at the beginning, first, and third months. Mean IOP was decreased at the third month. The most common side effect was hyperemia (43.6%). We concluded that latanoprost reduces IOP better than fixed combination and its topical side effects are tolerable.

Impact of the introduction of generic latanoprost on glaucoma medication adherence.

PubMed

Stein, Joshua D; Shekhawat, Nakul; Talwar, Nidhi; Balkrishnan, Rajesh

2015-04-01

To assess possible changes in medication adherence to prostaglandin analog (PGA) regimens among patients with open-angle glaucoma (OAG) after the initial introduction of generic PGAs. Longitudinal cohort analysis. Patients older than 40 years with OAG continuously enrolled in a nationwide managed-care network during 2009-2012 who used PGAs. Mean adherence rates were calculated for topical PGA use during the 18 months before the introduction of generic latanoprost (September 2009-February 2011) and the 18 months after generic latanoprost became available (July 2011-December 2012). The rates were compared between persons who continued to use brand-name PGAs once generic latanoprost became available and others who switched to generic latanoprost. Multivariable logistic regression identified variables associated with an improvement or worsening of adherence of ≥25%. Mean adherence rates and odds of 25% or more improved or worsened adherence (with 95% confidence intervals [CIs]). A total of 8427 patients met the study eligibility criteria. Compared with persons switching to generic latanoprost, patients who continued taking brand name PGAs were 28% less likely to have improved adherence (odds ratio [OR], 0.72; 95% CI, 0.55-0.94) and 39% more likely to have reduced adherence (OR, 1.39; 1.04-1.86) of ≥25%. Improved adherence after the generic drug's introduction was also associated with higher monthly medication copay in the pregeneric period (P = 0.02), lower copay after introduction of the generic drug (P < 0.0001), and black race (OR, 1.25; 95% CI, 1.04-1.50). Six-hundred twelve patients (7.3%) discontinued all antiglaucoma interventions when generic latanoprost became available. Given that cost can significantly deter adherence, switching patients to generic medications may help improve patients' drug-regimen adherence. A considerable number of patients discontinued glaucoma drug use altogether when generic latanoprost became available. Ophthalmologists should work with insurers and pharmacists to prevent such discontinuation of use as generic forms of other PGA agents become available. Copyright © 2015 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Advantages of Efficacy and Safety of Fixed-Dose Tafluprost/Timolol Combination Over Fixed-Dose Latanoprost/Timolol Combination.

PubMed

Fuwa, Masahiro; Ueda, Kenji; Akaishi, Takahiro; Yamashita, Naoko; Kirihara, Tomoko; Shimazaki, Atsushi; Mano, Hidetoshi; Kawazu, Kouichi

2016-01-01

To compare the safety and efficacy of fixed-dose tafluprost/timolol combination (Taf/T-FDC) with those of fixed-dose latanoprost/timolol combination (Lat/T-FDC) by measuring the intraocular pressure (IOP)-lowering effect, ocular pharmacokinetics, and ocular surface toxicity. The IOP-lowering effect of Taf/T-FDC and Lat/T-FDC in ocular normotensive monkeys was evaluated at 4 and 8 h after instillation in study A, at 12, 14, 16, and 18 h after instillation in study B, and at 24, 26, 28, and 30 h after instillation in study C. Drug penetration into the eye was evaluated by measuring the concentrations of timolol, tafluprost acid (active metabolic form of tafluprost), and latanoprost acid (active metabolic form of latanoprost) using liquid chromatography coupled with tandem mass spectrometry after single instillation of Taf/T-FDC or Lat/T-FDC to Sprague Dawley rats. Cytotoxicity following 1-30 min exposure of SV40-transformed human corneal epithelial cells to Taf/T-FDC or Lat/T-FDC was analyzed using 3-(4,5-dimethylthiazol-2-yl)-5-(3-carboxymethoxyphenyl)-2-(4-sulfophenyl)-2H-tetrazolium assays. Undiluted and 10-fold diluted solutions of each FDC were evaluated. The IOP-lowering effect of Taf/T-FDC was almost equivalent to that of Lat/T-FDC at 4-8 h after instillation. The peak IOP reduction of Taf/T-FDC and Lat/T-FDC was observed at 8 h after instillation, and there is no difference between the two. The difference between them was observed at 24-30 h after instillation, and Taf/T-FDC demonstrated a significantly greater IOP-lowering effect than Lat/T-FDC at 24-30 h after instillation. The IOP-lowering effect of Taf/T-FDC was sustained up to 30 h after instillation, while that of Lat/T-FDC had almost disappeared at 28 h after instillation. Timolol concentrations in aqueous humor after Taf/T-FDC instillation were higher than those after Lat/T-FDC instillation (Cmax, 3870 ng/mL vs 1330 ng/mL; AUCinf, 3970 ng·h/mL vs 1250 ng·h/mL). The concentrations of tafluprost acid and latanoprost acid in aqueous humor after instillation of Taf/T-FDC and Lat/T-FDC, respectively, were similar to those after instillation of mono-preparations of tafluprost and latanoprost, respectively. The cytotoxic effect of Taf/T-FDC to the human corneal epithelial cells was significantly lower than that of Lat/T-FDC at all evaluated time points in both undiluted and 10-fold diluted FDCs. Taf/T-FDC provides increased IOP-lowering effect duration and lower potential ocular surface toxicity than Lat/T-FDC.

Advantages of Efficacy and Safety of Fixed-Dose Tafluprost/Timolol Combination Over Fixed-Dose Latanoprost/Timolol Combination

PubMed Central

Fuwa, Masahiro; Ueda, Kenji; Akaishi, Takahiro; Yamashita, Naoko; Kirihara, Tomoko; Shimazaki, Atsushi; Mano, Hidetoshi; Kawazu, Kouichi

2016-01-01

Purpose To compare the safety and efficacy of fixed-dose tafluprost/timolol combination (Taf/T-FDC) with those of fixed-dose latanoprost/timolol combination (Lat/T-FDC) by measuring the intraocular pressure (IOP)-lowering effect, ocular pharmacokinetics, and ocular surface toxicity. Methods The IOP-lowering effect of Taf/T-FDC and Lat/T-FDC in ocular normotensive monkeys was evaluated at 4 and 8 h after instillation in study A, at 12, 14, 16, and 18 h after instillation in study B, and at 24, 26, 28, and 30 h after instillation in study C. Drug penetration into the eye was evaluated by measuring the concentrations of timolol, tafluprost acid (active metabolic form of tafluprost), and latanoprost acid (active metabolic form of latanoprost) using liquid chromatography coupled with tandem mass spectrometry after single instillation of Taf/T-FDC or Lat/T-FDC to Sprague Dawley rats. Cytotoxicity following 1–30 min exposure of SV40-transformed human corneal epithelial cells to Taf/T-FDC or Lat/T-FDC was analyzed using 3-(4,5-dimethylthiazol-2-yl)-5-(3-carboxymethoxyphenyl)-2-(4-sulfophenyl)-2H-tetrazolium assays. Undiluted and 10-fold diluted solutions of each FDC were evaluated. Results The IOP-lowering effect of Taf/T-FDC was almost equivalent to that of Lat/T-FDC at 4–8 h after instillation. The peak IOP reduction of Taf/T-FDC and Lat/T-FDC was observed at 8 h after instillation, and there is no difference between the two. The difference between them was observed at 24–30 h after instillation, and Taf/T-FDC demonstrated a significantly greater IOP-lowering effect than Lat/T-FDC at 24–30 h after instillation. The IOP-lowering effect of Taf/T-FDC was sustained up to 30 h after instillation, while that of Lat/T-FDC had almost disappeared at 28 h after instillation. Timolol concentrations in aqueous humor after Taf/T-FDC instillation were higher than those after Lat/T-FDC instillation (Cmax, 3870 ng/mL vs 1330 ng/mL; AUCinf, 3970 ng·h/mL vs 1250 ng·h/mL). The concentrations of tafluprost acid and latanoprost acid in aqueous humor after instillation of Taf/T-FDC and Lat/T-FDC, respectively, were similar to those after instillation of mono-preparations of tafluprost and latanoprost, respectively. The cytotoxic effect of Taf/T-FDC to the human corneal epithelial cells was significantly lower than that of Lat/T-FDC at all evaluated time points in both undiluted and 10-fold diluted FDCs. Conclusion Taf/T-FDC provides increased IOP-lowering effect duration and lower potential ocular surface toxicity than Lat/T-FDC. PMID:27383260

Degree and duration of corneal anesthesia after topical application of 0.4% oxybuprocaine hydrochloride ophthalmic solution in ophthalmically normal dogs.

PubMed

Douet, Jean-Yves; Michel, Julien; Regnier, Alain

2013-10-01

To assess the anesthetic efficacy and local tolerance of topically applied 0.4% oxybuprocaine ophthalmic solution to in dogs and compare its effects with those of 1% tetracaine solution. 34 ophthalmically normal Beagles. Dogs were assigned to 2 groups, and baseline corneal touch threshold (CTT) was measured bilaterally with a Cochet-Bonnet aesthesiometer. Dogs of group 1 (n = 22) received a single drop of 0.4% oxybuprocaine ophthalmic solution in one eye and saline (0.9% NaCl) solution (control treatment) in the contralateral eye. Dogs of group 2 (n = 12) received a single drop of 0.4% oxybuprocaine ophthalmic solution in one eye and 1% tetracaine ophthalmic solution in the contralateral eye. The CTT of each eye was measured 1 and 5 minutes after topical application and then at 5-minute intervals until 75 minutes after topical application. CTT changes over time differed significantly between oxybuprocaine-treated and control eyes. After instillation of oxybuprocaine, maximal corneal anesthesia (CTT = 0) was achieved within 1 minute, and CTT was significantly decreased from 1 to 45 minutes, compared with the baseline value. No significant difference in onset, depth, and duration of corneal anesthesia was found between oxybuprocaine-treated and tetracaine-treated eyes. Conjunctival hyperemia and chemosis were detected more frequently in tetracaine-treated eyes than in oxybuprocaine-treated eyes. Topical application of oxybuprocaine and tetracaine similarly reduced corneal sensitivity in dogs, but oxybuprocaine was less irritating to the conjunctiva than was tetracaine.

Long-term results of treatment with diquafosol ophthalmic solution for aqueous-deficient dry eye.

PubMed

Koh, Shizuka; Ikeda, Chikako; Takai, Yoshihiro; Watanabe, Hitoshi; Maeda, Naoyuki; Nishida, Kohji

2013-09-01

To evaluate the preliminary long-term efficacy of diquafosol ophthalmic solution for aqueous-deficient dry eye. Fifteen patients with mild-to-moderate aqueous-deficient dry eye were enrolled. After a washout period, the patients were treated with 3 % diquafosol ophthalmic solution for 6 months. We assessed 12 subjective dry eye symptoms, corneal and conjunctival staining with fluorescein, tear film break-up time (BUT), lower tear meniscus height measured with anterior-segment optical coherence tomography, Schirmer's testing, and adverse reactions at baseline and 1, 3, and 6 months after the start of treatment. Treatment with diquafosol ophthalmic solution significantly improved dry eye symptoms, corneal staining, BUT, and tear meniscus height at 1 month and maintained the effectiveness for 6 months. Conjunctival staining significantly improved 3 and 6 months after treatment. No significant adverse reactions developed. Prolonged use of diquafosol ophthalmic solution for 6 months produced significant improvement both subjectively (dry eye symptom score) and objectively (ocular staining score and tear function tests) for aqueous-deficient dry eye.

Meta-analysis of the Efficacy and Safety of Latanoprost Monotherapy in Patients With Angle-closure Glaucoma.

PubMed

Chen, Ru; Yang, Ke; Zheng, Zhong; Ong, Moh-Lim; Wang, Ning-Li; Zhan, Si-Yan

2016-03-01

To systematically evaluate the safety and efficacy of latanoprost monotherapy for the treatment of patients with angle-closure glaucoma. We searched EMBASE, Medline, Cochrane Library, Chinese Journal Full-text Database (CNKI), Chinese Science and Technology Periodical Database (VIP), and Wang Fang using the search terms "latanoprost" (or its commercial name, Xalatan) and "angle-closure glaucoma." Resulting articles were then screened using preset inclusion criteria. Subgroup and sensitivity analyses were performed to evaluate the impact of research population, research type (blinded or controlled), and withdrawal/loss to follow-up. A total of 17 studies (n=807) were included in this meta-analysis. The primary outcome measure was intraocular pressure (IOP). Changes in the mean, peak, and trough IOP from baseline were used as effect measures. As I statistic revealed statistical heterogeneity, the random-effects model was applied. With the exception of 2 non-Asian populations from Australia and Peru, all 13 countries included in this study were from Asia. Latanoprost reduced mean IOP by 7.9 mm Hg (32.4%), peak IOP by 7.4 mm Hg (29.8%), and trough IOP by 7.9 mm Hg (32.5%). The most frequent ocular adverse effects were ocular hyperemia, discomfort (including eye irritation, ocular discomfort, foreign body sensation, and itching), and blurred vision with a total incidence rate of 9.4%, 8.7%, and 5.2%, respectively. Systemic adverse effects encompass rhinitis, dizziness, headache, and nonspecific skin pigmentation. Latanoprost is effective at reducing the IOP of patients with angle-closure glaucoma. Adverse reactions associated with latanoprost were mainly ocular in nature.

21 CFR 524.1484e - Neomycin sulfate and polymyxin B sulfate ophthalmic solution.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Neomycin sulfate and polymyxin B sulfate... DOSAGE FORM NEW ANIMAL DRUGS § 524.1484e Neomycin sulfate and polymyxin B sulfate ophthalmic solution. (a) Specifications. Each milliliter of the ophthalmic preparation contains 5.0 milligrams neomycin sulfate (3.5...

21 CFR 524.1484e - Neomycin sulfate and polymyxin B sulfate ophthalmic solution.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Neomycin sulfate and polymyxin B sulfate... DOSAGE FORM NEW ANIMAL DRUGS § 524.1484e Neomycin sulfate and polymyxin B sulfate ophthalmic solution. (a) Specifications. Each milliliter of the ophthalmic preparation contains 5.0 milligrams neomycin sulfate (3.5...

21 CFR 524.1484e - Neomycin sulfate and polymyxin B sulfate ophthalmic solution.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Neomycin sulfate and polymyxin B sulfate... DOSAGE FORM NEW ANIMAL DRUGS § 524.1484e Neomycin sulfate and polymyxin B sulfate ophthalmic solution. (a) Specifications. Each milliliter of the ophthalmic preparation contains 5.0 milligrams neomycin sulfate (3.5...

21 CFR 524.1484e - Neomycin sulfate and polymyxin B sulfate ophthalmic solution.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Neomycin sulfate and polymyxin B sulfate... DOSAGE FORM NEW ANIMAL DRUGS § 524.1484e Neomycin sulfate and polymyxin B sulfate ophthalmic solution. (a) Specifications. Each milliliter of the ophthalmic preparation contains 5.0 milligrams neomycin sulfate (3.5...

Efficacy of contact lens disinfecting solutions against Staphylococcus aureus and Pseudomonas aeruginosa.

PubMed

Manuj, Kapur; Gunderson, Charlise; Troupe, John; Huber, Mary E

2006-07-01

To evaluate the disinfection properties of multipurpose contact lens disinfection solutions, based on the International Organization for Standardization (ISO) 14729 guidelines. ReNu with MoistureLoc Multi-Purpose Solution, OPTI-FREE Express with Aldox Multi-Purpose Solution, Betadine 5% sterile ophthalmic preparation solution (povidone iodine), and 0.9% normal saline solution were inoculated with strains of Staphylococcus aureus and Pseudomonas aeruginosa. Surviving bacteria were quantified at specified times. ReNu with MoistureLoc, OPTI-FREE Express, and 5% ophthalmic povidone iodine were effective in achieving a 5-log reduction in bacterial count. Additionally, all three products maintained their effectivity at 72 hours. However, ReNu with MoistureLoc and povidone iodine resulted in the greatest reduction in bacterial colonization. ReNu with MoistureLoc, OPTI-FREE Express, and 5% ophthalmic povidone iodine meet the ISO 14729 guidelines for standalone contact lens solutions. However, ReNu with MoistureLoc and 5% ophthalmic povidone iodine are most efficient in reducing and maintaining low bacterial count for a period of 72 hours.

A pilot comparative study of topical latanoprost and tacrolimus in combination with narrow-band ultraviolet B phototherapy and microneedling for the treatment of nonsegmental vitiligo.

PubMed

Korobko, Igor V; Lomonosov, Konstantin M

2016-11-01

Prostaglandins and their analogues are beneficial as topical agents in vitiligo treatment, yet neither of the previous study addressed their comparative efficiency with conventional topical agents used in vitiligo treatment. In this pilot (24 patients) left-right comparative study we addressed efficiency of prostaglandin F2α analogue latanoprost versus tacrolimus when combined with narrow-band ultraviolet B and microneedling in repigmentation of nonsegmental vitiligo lesions. Our results confirm potency of prostaglandins, in particular, that of latanoprost, in inducing repigmentation, with the efficiency being at least comparable to that of tacrolimus, while contribution of microneedling remains unclear. In summary, results of our study provide further evidences for justified use of prostaglandins, in particular, latanoprost, in vitiligo treatment. In turn, this warrants future studies on the topic aiming to conclusively introduce prostaglandin-based formulations as conventional agents for vitiligo management. © 2016 Wiley Periodicals, Inc.

Tafluprost Ophthalmic

MedlinePlus

... your doctor.Tafluprost ophthalmic comes in single-use containers. The solution from one container should be used immediately after opening for one or both eyes. Dispose of each single-use container and any remaining solution after one use.Tafluprost ...

Degree of corneal anesthesia after topical application of 0.4% oxybuprocaine ophthalmic solution in normal equids.

PubMed

Little, Erika; Yvorchuk-St Jean, Kathy; Little, William; Sithole, Fortune; St Jean, Guy

2016-10-01

Oxybuprocaine hydrochloride ophthalmic solution has been widely used off-label in horses and donkeys, despite lack of data demonstrating efficacy and safety in these species. The objective of this study was to assess anesthetic efficacy of 0.4% oxybuprocaine hydrochloride ophthalmic solution in horses ( n = 5) and donkeys ( n = 24) and compare the effects with 0.5% proparacaine hydrochloride ophthalmic solution. The baseline corneal touch threshold (CTT) was measured with a Cochet-Bonnet esthesiometer. Donkeys ( n = 12) and horses ( n = 5) in group A received sterile ophthalmic solutions 0.4% oxybuprocaine with fluorescein (also termed benoxinate with fluorescein, abbreviated as ben + flu) instilled in one eye and 0.9% sterile sodium chloride solution (NaCl) with fluorescein (Na + flu) in the contralateral eye. Donkeys ( n = 12) and horses ( n = 5) in group B received sterile ophthalmic solutions (ben + flu) in one eye and 0.5% proparacaine with fluorescein (prop + flu) in the contralateral eye. The CTT was measured at 1 and 5 min post-application and at 5-minute intervals until 75 min after treatment. The CTT changes over time differed significantly between oxybuprocaine-treated and control eyes ( P < 0.001). The CTT continued to decrease throughout the duration of the study when compared with baseline values. No statistically significant difference in onset, depth, or duration of corneal anesthesia was found between oxybuprocaine and proparacaine treated eyes during the time of the study. Interestingly, horses were shown to have a significantly more sensitive cornea than donkeys ( P = 0.002). Oxybuprocaine and proparacaine reduced corneal sensitivity in donkeys and horses. No local irritation was observed with 0.4% oxybuprocaine.

Degree of corneal anesthesia after topical application of 0.4% oxybuprocaine ophthalmic solution in normal equids

PubMed Central

Little, Erika; Yvorchuk-St. Jean, Kathy; Little, William; Sithole, Fortune; St. Jean, Guy

2016-01-01

Oxybuprocaine hydrochloride ophthalmic solution has been widely used off-label in horses and donkeys, despite lack of data demonstrating efficacy and safety in these species. The objective of this study was to assess anesthetic efficacy of 0.4% oxybuprocaine hydrochloride ophthalmic solution in horses (n = 5) and donkeys (n = 24) and compare the effects with 0.5% proparacaine hydrochloride ophthalmic solution. The baseline corneal touch threshold (CTT) was measured with a Cochet-Bonnet esthesiometer. Donkeys (n = 12) and horses (n = 5) in group A received sterile ophthalmic solutions 0.4% oxybuprocaine with fluorescein (also termed benoxinate with fluorescein, abbreviated as ben + flu) instilled in one eye and 0.9% sterile sodium chloride solution (NaCl) with fluorescein (Na + flu) in the contralateral eye. Donkeys (n = 12) and horses (n = 5) in group B received sterile ophthalmic solutions (ben + flu) in one eye and 0.5% proparacaine with fluorescein (prop + flu) in the contralateral eye. The CTT was measured at 1 and 5 min post-application and at 5-minute intervals until 75 min after treatment. The CTT changes over time differed significantly between oxybuprocaine-treated and control eyes (P < 0.001). The CTT continued to decrease throughout the duration of the study when compared with baseline values. No statistically significant difference in onset, depth, or duration of corneal anesthesia was found between oxybuprocaine and proparacaine treated eyes during the time of the study. Interestingly, horses were shown to have a significantly more sensitive cornea than donkeys (P = 0.002). Oxybuprocaine and proparacaine reduced corneal sensitivity in donkeys and horses. No local irritation was observed with 0.4% oxybuprocaine. PMID:27733789

Comparison of systemic absorption between ofloxacin ophthalmic in situ gels and ofloxacin conventional ophthalmic solutions administration to rabbit eyes by HPLC-MS/MS.

PubMed

Li, Jiawei; Zhao, Hainan; Okeke, Chukwunweike Ikechukwu; Li, Lin; Liu, Zhidong; Yin, Zhongpeng; Zhuang, Pengwei; Sun, Jingtong; Wu, Tao; Wang, Meng; Li, Nan; Pi, Jiaxin; Zhang, Qian; Zhang, Rui; Ma, Li; Pang, Xiaochen; Liu, Zhanbiao; Zhang, Li; Fan, Lili

2013-06-25

In recent years, many pharmaceutical scientists have focused on developing the in situ gel-forming systems to overcome the poor bioavailability and therapeutic response exhibited by conventional ophthalmic solutions due to rapid pre-corneal elimination of the drug. The present work was to compare the systemic absorptions of ophthalmic ofloxacin in situ gel with the conventional ofloxacin eye drop after topical instillation to rabbit eyes by HPLC-MS/MS method and also determine the relative contribution of the nasal and the conjunctival mucosae to systemic ofloxacin absorption following topical instillation. The systemic AUC, Cmax, Tmax and Ke for ophthalmic in situ gel and ophthalmic solution after ocular instillation were 202.63±118.85 and 202.25±57.74 ng mL(-1) h, 54.22±28.31 and 48.4±25.97 ng mL(-1), 1.08±0.20 and 1.25±0.88 h, 0.0576±0.0207 and 0.0388±0.0248, respectively. And the values for the ratios of the AUC of anterior chamber of rabbit eye to blood plasma, AUCac/AUCpl, for ofloxacin conventional eye drop and in situ gel were 0.25 and 0.52, respectively. Statistic results showed that there was no significant difference in systemic absorption between the test groups and the reference groups (P>0.05) as both formulations have an AUCsa/AUCpl of 0.35. Therefore, the ophthalmic in situ gel may not decrease the drugs systemic absorption when administered in an equivalent dose as ophthalmic solutions into the rabbit eyes. Copyright © 2013 Elsevier B.V. All rights reserved.

New fluoroprostaglandin F(2alpha) derivatives with prostanoid FP-receptor agonistic activity as potent ocular-hypotensive agents.

PubMed

Nakajima, Tadashi; Matsugi, Takeshi; Goto, Wakana; Kageyama, Masaaki; Mori, Nobuaki; Matsumura, Yasushi; Hara, Hideaki

2003-12-01

To find new prostanoid FP-receptor agonists possessing potent ocular-hypotensive effects with minimal side effects, we evaluated the agonistic activities of newly synthesized prostaglandin F(2alpha) derivatives for the prostanoid FP-receptor both in vitro and in vivo. The iris constrictions induced by the derivatives and their effects on melanin content were examined using cat isolated iris sphincters and cultured B16 melanoma cells, respectively. The effects of derivative ester forms on miosis and intraocular pressure (IOP) were evaluated in cats and cynomolgus monkeys, respectively. Of these derivatives, 6 out of 12 compounds were more potent iris constrictors, with EC(50) values of 0.6 to 9.4 nM, than a carboxylic acid of latanoprost (EC(50)=13.6 nM). A carboxylic acid of latanoprost (100 microM) significantly increased the melanin content of cultured B16 melanoma cells, but some 15,15-difluoro derivatives, such as AFP-157 and AFP-172, did not. Topically applied AFP-168, AFP-169 and AFP-175 (isopropyl ester, methyl ester and ethyl ester forms, respectively, of AFP-172) induced miosis in cats more potently than latanoprost. AFP-168 (0.0005%) reduced IOP to the same extent as 0.005% latanoprost (for at least 8 h). These findings indicate that 15,15-difluoroprostaglandin F(2alpha) derivatives, especially AFP-168, have more potent prostanoid FP-receptor agonistic activities than latanoprost. Hence, AFP-168 may be worthy of further evaluation as an ocular-hypotensive agent.

In vitro study of antiadipogenic profile of latanoprost, travoprost, bimatoprost, and tafluprost in human orbital preadiopocytes.

PubMed

Choi, Hee Young; Lee, Ji Eun; Lee, Ji Woong; Park, Hyun Jun; Lee, Ji Eun; Jung, Jae Ho

2012-04-01

To investigate the effect of prostaglandin F2α (PGF2α), latanoprost, travoprost, bimatoprost, and tafluprost on human orbital preadipocyte differentiation and intracellular lipid storage, and to reveal the potential mechanisms by which topical prostaglandin analogs induce orbital fat volume reduction and cause deep superior sulcus syndrome. Human orbital adipose precursors were treated in vitro for 24 h (day 1) with PGF2α, latanoprost, travoprost, bimatoprost, and tafluprost in their commercial formulations (1:100 dilution). Expressions of adipogenic transcription factor, peroxisome proliferator-activated receptor-gamma (PPARγ), and CCAAT-enhancer-binding protein α (C/EBPα) were determined by real-time reverse transcription-polymerase chain reaction (RT-PCR) at day 7. At 14 days, cells were stained with oil red O, intracellular lipid accumulation was evaluated by lipid absorbance, and adipocyte expression marker [Lipoprotein lipase (LPL)] was determined by real-time RT-PCR. Our results showed that PGF2α and topical prostaglandin analogs down-regulated the expression of PPARγ and C/EBPα, and inhibited accumulation of intra-cytoplasmic lipid droplets and expression of LPL compared with the untreated control. Comparison between the 4 drugs showed that latanoprost had the weakest antiadipogenic effect, and bimatoprost induced the most significant reduction of adipogenesis. Latanoprost, travoprost, bimatoprost, and tafluprost inhibited human preadipocyte differentiation and intracellular lipid accumulation. Morphologic and metabolic changes in orbital adipocytes caused by PGF2α analogs are a possible pathophysiologic explanation of superior eyelid deepening in patients with glaucoma.

A multicenter, retrospective chart review study comparing index therapy change rates in open-angle glaucoma or ocular hypertension patients newly treated with latanoprost or travoprost-Z monotherapy.

PubMed

Fain, Joel M; Kotak, Sameer; Mardekian, Jack; Bacharach, Jason; Edward, Deepak P; Rauchman, Steven; Brevetti, Teresa; Fox, Janet L; Lovelace, Cherie

2011-06-13

Because latanoprost and the original formulation of travoprost that included benzalkonium chloride (BAK) have been shown to be similar with regard to tolerability, we compared initial topical intraocular pressure (IOP)-lowering medication change rates in patients newly treated with latanoprost or travoprost-Z monotherapy. At 14 clinical practice sites, medical records were abstracted for patients with a diagnosis of open-angle glaucoma or ocular hypertension and who were ≥40 years of age, had a baseline and at least one follow-up visit, and had no prior history of ocular prostaglandin use. Data regarding demographics, ocular/systemic medical histories, clinical variables, therapy initiations and reasons for changes, adverse events, and resource utilization were recorded from randomly chosen eligible charts. Primary outcomes were rates of and reasons for changing from the initial therapy within six months and across the full study period (1000 days). Data from 900 medical charts (latanoprost, 632; travoprost-Z, 268) were included. For both cohorts, average follow-up was >1 year. Cohorts were similar with regard to age (median ~67 years), gender distribution (>50% female), and diagnosis (~80% with open-angle glaucoma). Within six months, rates of index therapy change for latanoprost versus travoprost-Z were 21.2% (134/632) and 28.7% (77/268), respectively (p = 0.0148); across the full study period, rates were 34.5% (218/632) and 45.2% (121/268), respectively (p = 0.0026). Among those who changed their index therapy, insufficient IOP control was the most commonly reported reason followed by adverse events; hyperemia was the most commonly reported adverse event at index therapy change. In this "real world" study of changes in therapy in patients prescribed initial monotherapy with latanoprost with BAK or travoprost-Z with SofZia, medication changes were common in both treatment groups but statistically significantly more frequent with travoprost-Z.

Netarsudil Ophthalmic

MedlinePlus

... an eye injury or develop an eye or eye lid infection while using netarsudil ophthalmic solution, ask your doctor if you can continue using netarsudil ophthalmic.If you wear contact lenses, remove them before instilling netarsudil. You may put them back in 15 minutes after you instill the drops.

Three percent diquafosol ophthalmic solution as an additional therapy to existing artificial tears with steroids for dry-eye patients with Sjögren's syndrome.

PubMed

Yokoi, N; Sonomura, Y; Kato, H; Komuro, A; Kinoshita, S

2015-09-01

To investigate the long-term results of 3% diquafosol ophthalmic solution as an alternative therapy to existing ophthalmic solutions, including topical immunosuppression, for the treatment of dry eye in patients with Sjögren's syndrome. This study involved 14 female dry-eye patients (mean age: 62.4 years) with Sjögren's syndrome who insufficiently responded to their current therapy. In all patients, 3% diquafosol ophthalmic solution was administered six times daily for 12 months in substitution for artificial tears and sodium hyaluronate ophthalmic solution. Their use of corticosteroid eye drops remained unchanged from that prior to the treatment with diquafosol sodium. The subjective symptoms assessed, and ocular signs including tear meniscus radius and the tear film breakup time, and ocular-surface epithelial damage score were examined at 1, 2, 3, 4, 5, 6, 9, and 12 months after initiating treatment. Among the subjective symptoms, significant improvement was obtained in dryness at 2 months post treatment, in eye fatigue at 1, 2, 3, 4, and 12 months post treatment, and in pain at 1, 2, 6, and 12 months post treatment. Difficulty in opening the eye, foreign body sensation, and redness were also significantly ameliorated at various time-points. The tear meniscus radius and the tear film breakup time were significantly improved throughout the observation period, and the corneal epithelial staining scores were significantly decreased at 3 months post treatment. In dry-eye patients with Sjögren's syndrome, treatment with 3% diquafosol ophthalmic solution improved both symptoms and signs, and that effectiveness was maintained for 12 months.

An ophthalmic solution of a peroxisome proliferator-activated receptor gamma agonist prevents corneal inflammation in a rat alkali burn model

PubMed Central

Uchiyama, Masaaki; Masuda, Yukinari; Nagasaka, Shinya; Fukuda, Yuh; Takahashi, Hiroshi

2013-01-01

Purpose We clarified the effects of an ophthalmic solution of a peroxisome proliferator-activated receptor gamma (PPARγ) agonist on corneal inflammation and wound healing after alkali burn injury in rats. Methods After alkali exposure, either an ophthalmic solution with 0.1% pioglitazone hydrochloride (the PPARγ group) or vehicle (the vehicle group) was topically applied to the cornea until day 14. Histological, immunohistochemical, and real-time reverse transcription polymerase chain reaction analysis were performed. Results After alkali injury, PPARγ expression increased, with the infiltration of many inflammatory cells. The infiltration of neutrophils and macrophages started from the corneal limbus within 6 h, and developed in the corneal center by day 7, with associated neovascularization. The accumulation of α-smooth muscle actin-positive myofibroblasts and the deposition of type III collagen were noted on day 14. The histological changes were suppressed significantly by treatment with the ophthalmic solution of the PPARγ agonist. In addition, the number of infiltrating M2 macrophages in the cornea was increased by PPARγ agonist treatment. In real-time reverse transcription polymerase chain reaction analysis, the messenger ribonucleic acid expression levels of interleukin-1β (IL-1β), IL-6, IL-8, monocyte chemoattractant protein-1, tumor necrosis factor-α, transforming growth factor beta 1, and vascular endothelial growth factor-A were decreased in the PPARγ group compared to the vehicle group in the early periods of corneal inflammation. Conclusions The ophthalmic solution of the PPARγ agonist inhibited inflammation, decreased the fibrotic reaction, and prevented neovascularization in the cornea from the early phase after alkali burn injury. The ophthalmic solution of the PPARγ agonist may provide a new treatment strategy with useful clinical applications for corneal inflammation and wound healing. PMID:24194635

Cell viability score as an integrated indicator for cytotoxicity of benzalkonium chloride-containing antiglaucoma eyedrops.

PubMed

Ayaki, Masahiko; Iwasawa, Atsuo; Niwano, Yoshimi

2012-01-01

We evaluated the in vitro cytotoxicity of benzalkonium chloride (BAK)-containing antiglaucoma eyedrops. We prepared cell cultures of SIRC, BCE C/D-1b, RC-1, and Chang conjunctiva. The viability of cell cultures was determined using the MTT and neutral red assays. The cell viability score (CVS) was used to compare the toxicity of test solutions. %CVS50 and %CVS40/80 of each eyedrop solution were 71 and 26 for Lumigan(®) (0.002% bimatoprost with 0.005% BAK), 100 and 99 for Tapros(®) (0.0015% tafluprost, a new formula from 2010 with 0.001% BAK), 39 and -29 for 2% Trusopt(®) (2% dorzolamide with 0.0075% BAK), 28 and -43 for Xalacom(®) (latanoprost/0.5% timolol with 0.02% BAK), 88 and 66 for DuoTrav(®) (travoprost/0.5% timolol with no BAK), 36 and -35 for Cosopt(®) (2% dorzolamide/0.5% timolol with 0.0075% BAK) and 53 and -1 for Combigan(®) (0.15% brimonidin/0.5% timolol with 0.005% BAK). Only Xalacom(®) and Tapros(®) did not show an apparent decrease in %CVS as compared to the corresponding concentration of BAK. In conclusion, the cytotoxicity of tested eyedrops was dependent on BAK. Only the eyedrops containing latanoprost or tafluprost showed a reduction in the cytotoxicity of BAK.

Efficacy and safety of preservative-free latanoprost eyedrops, compared with BAK-preserved latanoprost in patients with ocular hypertension or glaucoma.

PubMed

Rouland, Jean-François; Traverso, Carlo Enrico; Stalmans, Ingeborg; Fekih, Lamia El; Delval, Laurent; Renault, Didier; Baudouin, Christophe

2013-02-01

To compare efficacy (intraocular pressure (IOP) reduction) and safety of preservative-free latanoprost (T2345) to benzalkonium chloride (BAK)-preserved latanoprost (BPL; Xalatan) in ocular hypertension (OHT) or primary open angle glaucoma (POAG) patients. Prospective, international, multicentre, randomised, investigator-masked, parallel-group trial. After a wash-out period, POAG or OHT patients, previously managed by BPL monotherapy, randomly received T2345 or BPL (one drop into the affected eye(s)) once daily from D0 to D84. Change in IOP was measured at 09:00 (±1 h) from D0 to D84 in the worse eye. Mean IOP reduction (D0-D84) was -8.6±2.6 mm Hg (-36%) on T2345 and -9.0±2.4 mm Hg (-38%) on BPL, confirming non-inferiority of T2345 to BPL. Non-inferiority of T2345 was observed from D15. The most frequent ocular adverse event, drug intolerance, was reported in 1 (0.5%) patient on T2345 versus 4 (2.1%) patients on BPL. Moderate to severe conjunctival hyperaemia was less frequent on T2345 than on BPL at D42 (20.2% vs 30.6%; p=0.003) and D84 (21.4% vs 29.1%; p=0.02). Upon instillation, the global subjective ocular symptom score was significantly lower on T2345 than BPL on D42 (0.15 vs 0.41; p=0.001) and D84 (0.18 vs 0.46; p=0.001). Preservative-free latanoprost has the same efficacy as BPL, with improved local tolerance.

21 CFR 524.1200b - Kanamycin ophthalmic solution.

Code of Federal Regulations, 2014 CFR

2014-04-01

... sensitive to kanamycin. For prophylaxis in traumatic conditions, removal of foreign bodies, and intraocular... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Kanamycin ophthalmic solution. 524.1200b Section 524.1200b Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

Switching from a preserved to a preservative-free prostaglandin preparation in topical glaucoma medication.

PubMed

Uusitalo, Hannu; Chen, Enping; Pfeiffer, Norbert; Brignole-Baudouin, Françoise; Kaarniranta, Kai; Leino, Markku; Puska, Päivi; Palmgren, Elina; Hamacher, Thomas; Hofmann, Günter; Petzold, Gernot; Richter, Ulrich; Riedel, Tobias; Winter, Martin; Ropo, Auli

2010-05-01

The purpose of this study was to investigate the tolerability and intraocular pressure (IOP) reducing effect of the first preservative-free prostaglandin tafluprost (Taflotan) in patients exhibiting ocular surface side-effects during latanoprost (Xalatan) treatment. A total of 158 patients were enrolled in this open-label multicentre study. Eligible patients had to have at least two ocular symptoms, or one sign and one symptom, during treatment with latanoprost. At baseline, the patients were directly switched from latanoprost to preservative-free tafluprost for 12 weeks. The patients were queried for ocular symptoms, and ocular signs were assessed by using tear break-up time, Schirmer's test, fluorescein staining and evaluation of conjunctival hyperaemia and blepharitis. In addition, HLA-DR and MUC5AC in conjunctival impression cytology specimens were analyzed, and a drop discomfort/quality of life (QoL) questionnaire was employed. IOP was measured at all visits. Preservative-free tafluprost maintained IOP at the same level after 12- weeks treatment (16.4 +/- 2.7 mmHg) as latanoprost at baseline (16.8 +/- 2.5 mmHg). During treatment with preservative-free tafluprost, the number of patients having irritation/burning/stinging (56.3%), itching (46.8%), foreign body sensation (49.4%), tearing (55.1%) and dry eye sensation (64.6%) decreased to 28.4%, 26.5%, 27.1%, 27.1% and 39.4% correspondingly. The number of the patients with abnormal fluorescein staining of cornea (81.6%) and conjunctiva (84.2%), blepharitis (60.1%), conjunctival hyperaemia (84.2%) and abnormal Schirmer's test (71.5%) was also reduced significantly to 40.6%, 43.2%, 40.6%, 60.0% and 59.4% correspondingly. The tear break-up time improved significantly from 4.5 +/- 2.5 seconds to 7.8 +/- 4.9 seconds. A reduction in the number of patients with abnormal conjunctival cells based on HLA-DR and MUC5AC was also detected. Preservative-free tafluprost maintained IOP at the same level as latanoprost, but was better tolerated in patients having signs or symptoms while on preserved latanoprost. Preservative-free tafluprost treatment resulted in improved QoL, increased patient satisfaction and drop comfort.

Assessment of ocular hypotensive effect and safety 12 months after changing from an unfixed combination to a latanoprost 0.005% + timolol maleate 0.5% fixed combination.

PubMed

Inoue, Kenji; Okayama, Ryoko; Higa, Risako; Wakakura, Masato; Tomita, Goji

2012-01-01

Latanoprost 0.005% + timolol maleate 0.5% combined eyedrops were recently made available in Japan. We prospectively investigated the intraocular pressure (IOP)-lowering effect, visual preservation effect, and adverse reactions of a one-year administration of this fixed combination. The subjects included 162 eyes from 162 patients diagnosed with either primary open-angle glaucoma or ocular hypertension and using an unfixed combination of latanoprost 0.005% and timolol maleate 0.5%. The unfixed combination was discontinued and replaced with the latanoprost 0.005% + timolol maleate 0.5% fixed combination with no washout period. IOP was measured before (baseline) and 3, 6, 9, and 12 months after the change. The mean deviation value of Humphrey field analysis was compared. Adverse reactions were examined at every follow-up. No significant differences were found between mean IOP values obtained at baseline (mean ± standard deviation, 15.2 ± 3.3 mmHg) 3 months (15.1 ± 3.2 mmHg), 6 months (15.3 ± 3.1 mmHg), 9 months (15.3 ± 3.1 mmHg), and 12 months (15.1 ± 3.2 mmHg) after the change from the unfixed to the fixed combination of eyedrops (P = 0.212). In addition, no significant differences were observed between mean deviation values obtained at baseline (-9.11 ± 6.94 dB) and 12 months (-10.08 ± 7.24 dB) after the change (P = 0.114). Thirty-one patients discontinued the fixed combination within 12 months of replacement, due to an insufficient IOP decrease (20 patients, 12.3%) and adverse reactions (11 patients, 6.8%). Following replacement of two eyedrop medications (latanoprost 0.005% and timolol maleate 0.5%) by one fixed combination (latanoprost 0.005% + timolol maleate 0.5%), IOP and visual field were preserved. However, 20% of the patients discontinued the new treatment because of an insufficient IOP decrease and complaints of adverse reactions.

Preparation of ophthalmic formulations containing cilostazol as an anti-glaucoma agent and improvement in its permeability through the rabbit cornea.

PubMed

Okamoto, Norio; Ito, Yoshimasa; Nagai, Noriaki; Murao, Takatoshi; Takiguchi, Yusuke; Kurimoto, Takuji; Mimura, Osamu

2010-01-01

To evaluate the pharmacological properties of cilostazol (CLZ), we examined its intraocular pressure (IOP) -lowering effect. CLZ is an inhibitor of Type III phosphodiesterase that increases intracellular cyclic AMP levels by restraining platelet aggregation, and has a potential protective effect against atherosclerosis. We attempted to apply it for use as an anti-glaucoma agent; however, the application of CLZ in the ophthalmic field is limited due to its poor water solubility. We attempted to enhance CLZ solubility using 2-hydroxypropyl-beta-cyclodextrin (HPbetaCD). The solubility of CLZ increased with increasing HPbetaCD concentrations, and 0.05% CLZ was dissolved in 10% HPbetaCD. Moreover, fine particle suspension of 0.5% CLZ in 5% HPbetaCD (soluble CLZ: ca. 0.027%) were prepared using a Microfluidizer, an impact-type emulsifying comminution device. In an in vitro transcorneal penetration experiment through the rabbit cornea, the CLZ penetration rate was dependent on the CLZ content of the solutions and suspensions. When a 0.05% CLZ ophthalmic solution was instilled into a rabbit eye, the absorption rate constant for CLZ into an aqueous humor was 0.0059+/-0.001 min(-1), and the elimination rate constant was 0.048+/-0.024 min(-1). Also CLZ ophthalmic solutions and fine particle suspension were examined to for their ability to reduce enhanced intraocular pressure (IOP) of rabbits in a darkroom. The instillation of 0.05% CLZ ophthalmic solutions and 0.5% CLZ fine particle suspensions into rabbit eyes reduced the enhanced IOP. These results demonstrate that the instillation of CLZ ophthalmic solutions and fine particle suspensions may represent an effective anti-glaucoma formulation.

Long-term effect of BAK-free travoprost on ocular surface and intraocular pressure in glaucoma patients after transition from latanoprost.

PubMed

Aihara, Makoto; Otani, Shin-ichiro; Kozaki, Jun; Unoki, Kazuhiko; Takeuchi, Masamitsu; Minami, Keiichiro; Miyata, Kazunori

2012-01-01

To assess the efficacy and tolerability of benzalkonium chloride (BAK)-free travoprost after transition from BAK-preserved latanoprost. This was a prospective, open-label, multicenter study in patients with open-angle glaucoma or ocular hypertension who had been treated with latanoprost monotherapy for at least 3 months. The main outcome measures were superficial punctate keratopathy (SPK), hyperemia, and intraocular pressure (IOP). At baseline, 1, 3, and 12 months, hyperemia, SPK, and IOP were consecutively assessed. Hyperemia was assessed using a 4-grade scale. SPK was assessed by fluorescence staining observed by Area-Density classification. The IOP was measured by Goldmann applanation tonometry. One hundred and fourteen patients participated in this study. Twenty-eight patients discontinued medications by 1 month. Sixty-seven patients completed the study. Transition from latanoprost to BAK-free travoprost showed no significant effect on hyperemia at 1 month, but showed significant decreases at 3 and 12 months compared with baseline (P<0.05). The prevalence of SPK, especially its severity score, at all points were significantly reduced compared with baseline (P<0.05). The IOP at baseline and at 12 months after transition was 14.9±3.4 and 14.3±3.3 mm Hg, indicating a significant reduction after the change in regimen compared with baseline (P<0.05). Treatment for 12 months with BAK-free travoprost after BAK-preserved latanoprost resulted in fewer ocular surface complications, as indicated by the reduced prevalence of SPK and decreased hyperemia, and no clinically relevant changes in IOP. BAK-free travoprost may have beneficial effects on the ocular surface while showing IOP-lowering efficacy comparable with BAK-preserved eye drops.

21 CFR 524.960 - Flumethasone, neomycin sulfate, and polymyxin B sulfate ophthalmic solutions.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Flumethasone, neomycin sulfate, and polymyxin B sulfate ophthalmic solutions. 524.960 Section 524.960 Food and Drugs FOOD AND DRUG ADMINISTRATION... TOPICAL DOSAGE FORM NEW ANIMAL DRUGS § 524.960 Flumethasone, neomycin sulfate, and polymyxin B sulfate...

21 CFR 524.960 - Flumethasone, neomycin sulfate, and polymyxin B sulfate ophthalmic solutions.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Flumethasone, neomycin sulfate, and polymyxin B sulfate ophthalmic solutions. 524.960 Section 524.960 Food and Drugs FOOD AND DRUG ADMINISTRATION... TOPICAL DOSAGE FORM NEW ANIMAL DRUGS § 524.960 Flumethasone, neomycin sulfate, and polymyxin B sulfate...

21 CFR 524.1200b - Kanamycin ophthalmic aqueous solution.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., removal of foreign bodies, and intraocular surgery. Instill a few drops into the affected eye every 3... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Kanamycin ophthalmic aqueous solution. 524.1200b Section 524.1200b Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

21 CFR 524.1200b - Kanamycin ophthalmic aqueous solution.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., removal of foreign bodies, and intraocular surgery. Instill a few drops into the affected eye every 3... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Kanamycin ophthalmic aqueous solution. 524.1200b Section 524.1200b Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

Diquafosol ophthalmic solution for dry eye treatment.

PubMed

Nakamura, Masatsugu; Imanaka, Takahiro; Sakamoto, Asuka

2012-07-01

There has been rapid progress in our understanding of dry eye pathogenesis, as well as the development of improved diagnostic clinical tests. Various types of dry eye treatment drugs have been developed. This review summarizes the basic and clinical research carried out in the development of diquafosol for ophthalmic use. Diquafosol is a dinucleotide, purinoreceptor P2Y(2) receptor agonist. Basic pharmacological studies have shown that it acts on P2Y(2) receptors at the ocular surface, to promote tear and mucin secretion via elevated intracellular Ca(2+) concentrations. Diquafosol also improves tear and mucin secretion in experimental dry eye models. Based on the results of laboratory experiments, the authors conducted a series of clinical studies in patients with dry eye disease. Diquafosol was effective in the treatment of dry eye disease at an optimal dose of 3% six times a day. In comparison to commercially available 0.1% sodium hyaluronate ophthalmic solution, 3% diquafosol ophthalmic solution showed non-inferiority in improving corneal fluorescein staining scores and superiority in improving keratoconjunctival Rose Bengal staining scores. Diquafosol ophthalmic solution has a novel mechanism of action that is characterized by its stimulatory effects on tear and mucin secretion. This drug has the potential to be effective in patients with tear film instability and short break-up time type of dry eye, which are essential factors in dry eye pathogenesis.

Communication: an ophthalmic practice issue.

PubMed

Whitton, S J

1995-12-01

In the 1990's communication becomes an ophthalmic practice issue. The present ophthalmic climate of cost containment, downsizing, budget cuts, and lack of appreciation of contributions, results in a low staff morale. Recognition of the effects of job satisfaction and productivity led one group to seek solutions. A communication task force was formed to identify problems and the appropriate interventions.

78 FR 27971 - Determination That REV-EYES (Dapiprazole Hydrochloride Ophthalmic Solution), 0.5%, Was Not...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-13

...] Determination That REV-EYES (Dapiprazole Hydrochloride Ophthalmic Solution), 0.5%, Was Not Withdrawn From Sale.... SUMMARY: The Food and Drug Administration (FDA) has determined that REV-EYES (dapiprazole hydrochloride... CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. REV-EYES (dapiprazole...

21 CFR 524.1044a - Gentamicin ophthalmic solution.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Gentamicin ophthalmic solution. 524.1044a Section 524.1044a Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... in § 510.600(c) of this chapter. (c) Conditions of use. (1) The drug is used in dogs and cats for the...

21 CFR 524.1044a - Gentamicin ophthalmic solution.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Gentamicin ophthalmic solution. 524.1044a Section 524.1044a Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... in § 510.600(c) of this chapter. (c) Conditions of use. (1) The drug is used in dogs and cats for the...

Long-term effect of latanoprost/timolol fixed combination in patients with glaucoma or ocular hypertension: A prospective, observational, noninterventional study

PubMed Central

2010-01-01

Background Prospective, observational studies that enroll large numbers of patients with few exclusion criteria may better reflect actual ongoing clinical experience than randomized clinical trials. Our purpose was to obtain efficacy and safety information from a cohort of subjects exposed to latanoprost/timolol fixed combination (FC) for ≥18 months using a prospective, observational design. Methods In all, 577 office-based ophthalmologists in Germany switched 2339 patients with glaucoma or ocular hypertension to latanoprost/timolol FC for medical reasons. Follow-up visits were scheduled for every 6 months over 24 months; physicians followed usual care routines. Intraocular pressure (IOP), visual field status, optic nerve head findings, and adverse events were recorded. Efficacy parameters were evaluated for the per protocol (PP) population; the safety population included subjects receiving ≥1 drop of FC. Physicians rated efficacy, tolerability, and subject compliance at month 24. Results Of the 2339 subjects switched to latanoprost/timolol FC (safety population), the primary reasons for switching were inadequate IOP reduction (78.2%) and desire to simplify treatment with once-daily dosing (29.4%; multiple reasons possible). In all, 1317 (56.3%) subjects completed the study, and 1028 (44.0%) were included in the PP population. Most discontinuations were due to loss to follow-up. Change in mean IOP from baseline to month 6 was -4.0 ± 4.31 mmHg, a reduction that was maintained throughout (P < 0.05 for change at all time points). By investigator assessments, optic disc parameters and visual field were stable over 24 months, and there was no relationship between IOP reduction over 24 months and development of a visual field defect. More than 90% of physicians rated latanoprost/timolol FC as "very good" or "good" for efficacy (PP population), tolerability, and compliance. The FC was safe and well tolerated. No change in iris color was reported by most subjects (83.1%) at month 24. Conclusions Over 24 months, latanoprost/timolol FC effectively lowers IOP levels and is well tolerated in patients with glaucoma or ocular hypertension who change from their previous ocular hypotensive therapy for medical reasons. Investigator assessments found optic disc parameters and visual field to be stable throughout 24 months of follow-up. PMID:20825668

Changes to upper eyelid orbital fat from use of topical bimatoprost, travoprost, and latanoprost.

PubMed

Park, Juwan; Cho, Hyun Kyung; Moon, Jung-Il

2011-01-01

To confirm the possible mechanism by which topical prostaglandin antiglaucoma drugs cause a deep superior sulcus. Among patients who used bimatoprost (Lumigan), latanoprost (Xalatan), or travoprost (Travatan) and who developed a deep upper lid sulcus, 18 eyes of 11 patients (mean age, 58.2 ± 8.9 years) were studied. Seven patients were binocular users of one of the eye drops and four were monocular users. Preaponeurotic orbital fat was obtained, and the mean adipocyte density compared. In the four monocular users, mean adipocyte density of treated eyes was 1758.21 ± 158.15 cells/mm(2), and that of untreated eyes was 1258.73 ± 127.54 cells/mm(2). This difference was statistically significant (P = 0.04), suggesting that the adipocytes were atrophied in the treated eyes. The mean adipocyte density of the bimatoprost group was 2073.35 ± 184.89 cells/mm(2), that of the travoprost group was 1623.46 ± 218.99 cells/mm(2), and that of the latanoprost group was 1468.20 ± 113.44 cells/mm(2). The densities of the bimatoprost and travoprost groups, but not of the latanoprost group (P = 0.75), were significantly different from that of the untreated group (P < 0.001). Fat atrophy can be considered a mechanism of upper eyelid sulcus deepening in patients using topical prostaglandin analogs. © Japanese Ophthalmological Society 2011.

21 CFR 524.1982 - Proparacaine hydrochloride ophthalmic solution.

Code of Federal Regulations, 2011 CFR

2011-04-01

...) Conditions of use. (1) The drug is indicated for use as a topical ophthalmic anesthetic in animals. It is used as an anesthetic in cauterization of corneal ulcers, removal of foreign bodies and sutures from...

21 CFR 524.1982 - Proparacaine hydrochloride ophthalmic solution.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) Conditions of use. (1) The drug is indicated for use as a topical ophthalmic anesthetic in animals. It is used as an anesthetic in cauterization of corneal ulcers, removal of foreign bodies and sutures from...

Effect of three ophthalmic solutions on chemical conjunctivitis in the neonate.

PubMed

Yasunaga, S

1977-02-01

In an attempt to reduce chemical conjunctivitis after silver nitrate prophylaxis, three different ophthalmic solutions (sodium chloride, sterile water, and a boric acid-sodium borate solution) were used to irrigate the eyes immediately after prophylaxis in 450 neonates. Sterile water significantly reduced (P less than .02) the prevalence of chemical conjunctivitis when compared to the conventional sodium chloride rinse. A significantly greater prevalence of chemical irritation in low-birth-weight infants was also noted (P less than .02).

An ex vivo human aqueous humor-concentration comparison of two commercial bromfenac formulations

PubMed Central

Walters, Thomas R; Smyth-Medina, Robert J; Cockrum, Paul C

2018-01-01

Purpose The purpose of this study was to quantify the concentration of bromfenac in the aqueous humor utilizing high-performance liquid chromatography mass spectrometry between two commercial nonsteroidal anti-inflammatory drugs, using aqueous humor concentrations to characterize pharmacokinetic proportional differences between 0.075% bromfenac ophthalmic solution in DuraSite (BromSite®) and 0.09% bromfenac ophthalmic solution (Bromday®). Methods In this multicenter, randomized, double-masked, two-arm, parallel-group, comparative, Phase II clinical trial, subjects were assigned to receive bromfenac in DuraSite or bromfenac ophthalmic solution in a 1:1 ratio. One drop of the masked test article was instilled into the study eye once a day for 2 days prior to and 3 hours prior (last instillation) to the subject’s cataract surgery. Aqueous humor samples were collected upon initial cataract incision for analysis of bromfenac levels. The primary end point was aqueous humor concentration of bromfenac at Day 3, at the initiation of cataract surgery. Aqueous humor samples were collected and analyzed for bromfenac levels. Results A total of 60 subjects completed the study, 30 in each group. The mean bromfenac aqueous humor concentration in subjects who received bromfenac in DuraSite was more than twice (49.33±41.87 ng/mL, P=0.004) that of subjects who received bromfenac ophthalmic solution (23.65±16.31 ng/mL) after three doses. Conclusion Mean bromfenac aqueous humor concentration in subjects receiving the DuraSite-containing bromfenac in DuraSite (0.075%) was significantly higher compared to subjects receiving bromfenac ophthalmic solution (0.09%) after 3 days of dosing. PMID:29849449

Clinical utility of 3% diquafosol ophthalmic solution in the treatment of dry eyes

PubMed Central

Koh, Shizuka

2015-01-01

Diquafosol is a drug used for dry eye treatment with a novel mechanism of action. It stimulates the secretion of tear fluid and mucin on the ocular surface, thus enabling us to selectively treat the tear film layer, playing an important role in the establishment of the concept of “Tear Film Oriented Therapy (TFOT)”, an effective therapeutic approach to dry eye in Japan. The 3% diquafosol ophthalmic solution has been widely used for the treatment of dry eye in clinical practice, and it is currently available in Japan and South Korea. This review provides an overview of the clinical utility of 3% diquafosol ophthalmic solution, focusing on the results of clinical studies on various types of dry eye, including aqueous-deficient dry eye, short tear film breakup time-type dry eye, and post dry eye after laser in situ keratomileusis. It also introduces the additive effect of diquafosol on sodium hyaluronate monotherapy for dry eye, and the effect of 3% diquafosol ophthalmic solution for dry eye-related conditions. Additionally, it summarizes the ocular effects of diquafosol in healthy human eyes. Lastly, the importance of improving tear film stability in dry eye treatment, as well as general advances in dry eye treatments, are described. PMID:26028958

Clinical utility of 3% diquafosol ophthalmic solution in the treatment of dry eyes.

PubMed

Koh, Shizuka

2015-01-01

Diquafosol is a drug used for dry eye treatment with a novel mechanism of action. It stimulates the secretion of tear fluid and mucin on the ocular surface, thus enabling us to selectively treat the tear film layer, playing an important role in the establishment of the concept of "Tear Film Oriented Therapy (TFOT)", an effective therapeutic approach to dry eye in Japan. The 3% diquafosol ophthalmic solution has been widely used for the treatment of dry eye in clinical practice, and it is currently available in Japan and South Korea. This review provides an overview of the clinical utility of 3% diquafosol ophthalmic solution, focusing on the results of clinical studies on various types of dry eye, including aqueous-deficient dry eye, short tear film breakup time-type dry eye, and post dry eye after laser in situ keratomileusis. It also introduces the additive effect of diquafosol on sodium hyaluronate monotherapy for dry eye, and the effect of 3% diquafosol ophthalmic solution for dry eye-related conditions. Additionally, it summarizes the ocular effects of diquafosol in healthy human eyes. Lastly, the importance of improving tear film stability in dry eye treatment, as well as general advances in dry eye treatments, are described.

Design of Novel Ophthalmic Formulation Containing Drug Nanoparticles and Its Usefulness as Anti-glaucoma Drugs.

PubMed

Nagai, Noriaki

2016-01-01

The ophthalmic application of drugs is the primary route of administration for the therapy of glaucoma; however, in traditional formulations, only small amounts of the administered drug penetrate the cornea to reach the desired intraocular tissue due to corneal barriers. Recently, nanoparticulate drug delivery is expected as a technology to overcome the difficulties in delivering drugs across biological barriers (improvement of bioavailability). In this study, we attempted to establish a new method for preparing solid drug nanoparticles by using a bead mill and various additives, and succeeded in preparing a high quality dispersion containing drug nanoparticles. For a more concrete example, a mean particle size of disulfiram (DSF) treated with bead mill is 183 nm. The corneal penetration and corneal residence time of DSF from the ophthalmic dispersion containing DSF nanoparticles were significantly higher than those from a 2-hydroxypropyl-β-cyclodextrin solution containing DSF (DSF solution). It is known that the administration of DSF has intraocular pressure (IOP)-reducing effects. The IOP-reducing effects of the ophthalmic dispersion containing DSF nanoparticles were significantly greater than those of the DSF solution in rabbits (the IOP was enhanced by placing the rabbits in a dark room for 5 h). In addition, the ophthalmic dispersion containing DSF nanoparticles is better tolerated by corneal epithelial cells than DSF solution. It is possible that dispersions containing DSF nanoparticles provide new possibilities for effectively treating glaucoma, and that ocular drug delivery systems using drug nanoparticles may expand their usage for therapy in the ophthalmologic field.

Polymeric hydrogels for novel contact lens-based ophthalmic drug delivery systems: a review.

PubMed

Xinming, Li; Yingde, Cui; Lloyd, Andrew W; Mikhalovsky, Sergey V; Sandeman, Susan R; Howel, Carol A; Liewen, Liao

2008-04-01

Only about 5% of drugs administrated by eye drops are bioavailable, and currently eye drops account for more than 90% of all ophthalmic formulations. The bioavailability of ophthalmic drugs can be improved by a soft contact lens-based ophthalmic drug delivery system. Several polymeric hydrogels have been investigated for soft contact lens-based ophthalmic drug delivery systems: (i) polymeric hydrogels for conventional contact lens to absorb and release ophthalmic drugs; (ii) polymeric hydrogels for piggyback contact lens combining with a drug plate or drug solution; (iii) surface-modified polymeric hydrogels to immobilize drugs on the surface of contact lenses; (iv) polymeric hydrogels for inclusion of drugs in a colloidal structure dispersed in the lens; (v) ion ligand-containing polymeric hydrogels; (vi) molecularly imprinted polymeric hydrogels which provide the contact lens with a high affinity and selectivity for a given drug. Polymeric hydrogels for these contact lens-based ophthalmic drug delivery systems, their advantages and drawbacks are critically analyzed in this review.

Formulation and stability of an extemporaneous 0.02% chlorhexidine digluconate ophthalmic solution.

PubMed

Lin, Shu-Chiao; Huang, Chih-Fen; Shen, Li-Jiuan; Wang, Hsueh-Ju; Lin, Chia-Yu; Wu, Fe-Lin Lin

2015-12-01

Acanthamoeba keratitis is difficult to treat because Acanthamoeba cysts are resistant to the majority of antimicrobial agents. Despite the efficacy of 0.02% chlorhexidine in treating Acanthamoeba keratitis, a lack of data in the literature regarding the formulation's stability limits its clinical use. The objective of this study was to develop an optimal extemporaneous 0.02% chlorhexidine digluconate ophthalmic formulation for patients in need. With available active pharmaceutical ingredients, 0.02% chlorhexidine digluconate sample solutions were prepared by diluting with BSS Plus Solution or acetate buffer. Influences of the buffer, type of container, and temperature under daily-open condition were assessed based on the changes of pH values and chlorhexidine concentrations of the test samples weekly. To determine the beyond-use date, the optimal samples were stored at 2-8°C or room temperature, and analyzed at time 0 and at Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, Week 12, and Week 24. Despite chlorhexidine exhibiting better stability in acetate buffer than in BSS solution, its shelf-life was < 14 days when stored in a light-resistant low-density polyethylene container. The acetate-buffered 0.02% chlorhexidine digluconate solution stored in light-resistant high-density polyethylene eyedroppers did not exhibit significant changes in pH or strength at any time interval. The acetate-buffered 0.02% chlorhexidine digluconate ophthalmic solution stored in light-resistant high-density polyethylene eyedroppers demonstrated excellent stability at 2-25°C for 6 months after being sealed and for 1 month after opening. This finding will enable us to prepare 0.02% chlorhexidine digluconate ophthalmic solutions based on a doctor's prescription. Copyright © 2014. Published by Elsevier B.V.

Bioavailability and biochemical effects of diclofenac sodium 0.1% ophthalmic solution in the domestic chicken (Gallus gallus domesticus).

PubMed

Griggs, Angela N; Yaw, Taylor J; Haynes, Joseph S; Ben-Shlomo, Gil; Tofflemire, Kyle L; Allbaugh, Rachel A

2017-03-01

To determine if topical ophthalmic diclofenac sodium 0.1% solution alters renal parameters in the domestic chicken, and to determine if the drug is detectable in plasma after topical ophthalmic administration. Thirty healthy domestic chickens. Over 7 days, six birds were treated unilaterally with one drop of artificial tear solution (group 1), 12 birds were treated unilaterally (group 2) and 12 bilaterally (group 3) with diclofenac sodium 0.1% ophthalmic solution. Treatments were provided every 12 h in all groups. Pre- and post-treatment plasma samples from all birds were evaluated for changes in albumin, total protein, and uric acid. Post-treatment samples of all birds, collected 15 min post-administration, were analyzed by high-performance liquid chromatography with mass spectrometry for diclofenac sodium detection. A randomly selected renal sample from each group was submitted for histopathologic review. Changes in pre- and post-treatment plasma albumin were significant (P < 0.05) in groups 2 and 3, but not for group 1. Pre- and post-treatment changes in total protein and uric acid were not significant for any group. Diclofenac sodium was not detectable (limit of detection = 0.10 ng/mL) in plasma samples from birds in group 1. Post-treatment concentration of diclofenac in group 3 was statistically greater than group 2 (P = 0.0008). Histopathologic changes did not identify diclofenac-induced acute renal tubular necrosis. Ophthalmic diclofenac sodium 0.1% administered topically every 12 h in one or both eyes for 7 days is detectable in systemic circulation in the domestic chicken, but does not cause overt significant changes in plasma uric acid or total protein. © 2016 American College of Veterinary Ophthalmologists.

Effect of diquafosol ophthalmic solution on the optical quality of the eyes in patients with aqueous-deficient dry eye.

PubMed

Koh, Shizuka; Maeda, Naoyuki; Ikeda, Chikako; Oie, Yoshinori; Soma, Takeshi; Tsujikawa, Motokazu; Watanabe, Hitoshi; Nishida, Kohji

2014-12-01

To investigate the short- and long-term effects of diquafosol ophthalmic solution on the optical quality of the eyes in patients with aqueous-deficient dry eye. Sixteen eyes in 16 patients with mild or moderate aqueous-deficient dry eye were treated with 3% diquafosol ophthalmic solution. Ocular higher-order aberrations (HOAs) were measured with a wavefront sensor before and at 15 min after diquafosol instillation at the baseline visit and at 4 weeks after treatment initiation. Dry eye symptoms, tear break-up time (BUT), corneal/conjunctival fluorescein staining and Schirmer's test were also evaluated before and after treatment with diquafosol. Treatment with diquafosol ophthalmic solution significantly improved dry eye symptoms, corneal staining and BUT. Compared with mean total HOAs at baseline (0.180 ± 0.06 μm), those at 4 weeks after treatment significantly decreased (0.148 ± 0.039 μm; p = 0.035), whereas those 15 min after diquafosol instillation at the baseline visit did not change significantly (0.170 ± 0.049 μm; p = 0.279). Although no significant change in HOAs was observed as a short-term effect of a single-drop instillation of diquafosol, long-term use of diquafosol to treat aqueous-deficient dry eye reduced HOAs as well as improved corneal epithelial damage and tear film stability. © 2014 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

Reliable intraocular pressure measurement using automated radio-wave telemetry.

PubMed

Paschalis, Eleftherios I; Cade, Fabiano; Melki, Samir; Pasquale, Louis R; Dohlman, Claes H; Ciolino, Joseph B

2014-01-01

To present an autonomous intraocular pressure (IOP) measurement technique using a wireless implantable transducer (WIT) and a motion sensor. The WIT optical aid was implanted within the ciliary sulcus of a normotensive rabbit eye after extracapsular clear lens extraction. An autonomous wireless data system (AWDS) comprising of a WIT and an external antenna aided by a motion sensor provided continuous IOP readings. The sensitivity of the technique was determined by the ability to detect IOP changes resulting from the administration of latanoprost 0.005% or dorzolamide 2%, while the reliability was determined by the agreement between baseline and vehicle (saline) IOP. On average, 12 diurnal and 205 nocturnal IOP measurements were performed with latanoprost, and 26 diurnal and 205 nocturnal measurements with dorzolamide. No difference was found between mean baseline IOP (13.08±2.2 mmHg) and mean vehicle IOP (13.27±2.1 mmHg) (P=0.45), suggesting good measurement reliability. Both antiglaucoma medications caused significant IOP reduction compared to baseline; latanoprost reduced mean IOP by 10% (1.3±3.54 mmHg; P<0.001), and dorzolamide by 5% (0.62±2.22 mmHg; P<0.001). Use of latanoprost resulted in an overall twofold higher IOP reduction compared to dorzolamide (P<0.001). Repeatability was ±1.8 mmHg, assessed by the variability of consecutive IOP measurements performed in a short period of time (≤1 minute), during which the IOP is not expected to change. IOP measurements in conscious rabbits obtained without the need for human interactions using the AWDS are feasible and provide reproducible results.

21 CFR 524.390b - Chloramphenicol ophthalmic solution.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS... susceptible to chloramphenicol. Therapy should be continued for 48 hours after the eye appears normal. (3) Limitations. Therapy for cats should not exceed 7 days. As with other antibiotics, prolonged use may result in...

Effects of prostaglandin F2alpha and latanoprost on phosphoinositide turnover, myosin light chain phosphorylation and contraction in cat iris sphincter.

PubMed

Ansari, Habib R; Davis, Angela M; Kaddour-Djebbar, Ismail; Abdel-Latif, Ata A

2003-06-01

The effects of the ocular hypotensive agents prostaglandin F(2alpha) (PGF(2alpha)) and its analog latanoprost on intraocular pressure (IOP) in both animals and human have been investigated extensively in the last two decades. While there is general agreement that application of these PGs to the eye alters IOP by altering the aqueous humor outflow of the eye via the uveoscleral and trabecular meshwork pathways, the mechanism of action of these agents on IOP lowering remains unclear. There is evidence which suggests that myosin light kinase (MLC kinase) may be involved in the IOP-lowering effects of these agents. Thus, the purpose of the present work was to investigate in cat iris sphincter the effects of these PGs on the MLC kinase signaling pathway, inositol phosphates production, MLC phosphorylation and contraction, in order to gain more information about the mechanism through which these agents modulate smooth muscle function and lower IOP. [(3)H]myo-inositol phosphates production was measured by ion-exchange chromatography, MLC kinase activity was measured by incorporation of (32)Pi into MLC, and changes in muscle tension were recorded isometrically. PGF(2alpha) and latanoprost induced contraction in a concentration-dependent manner with EC(50) values of 18.6 and 29.9 nM, respectively, and increased inositol phosphates production in a concentration-dependent manner. At 1 microM, PGF(2alpha) and latanoprost increased inositol phosphates formation by 125 and 102% over basal, respectively. PGF(2alpha) and latanoprost increased MLC phosphorylation in a concentration- and time-dependent manner, at 1 microM and 5 min incubation, the PGs increased the MLC response by 181 and 176% over basal, respectively. In general, PGF(2alpha) was slightly more potent in inducing the biochemical and pharmacological responses. Wortmannin, ML-7 and ML-9, selective inhibitors of MLC kinase, inhibited significantly PGF(2alpha)- and latanoprost-induced MLC phosphorylation and contraction. These results demonstrate for the first time involvement of the MLC kinase pathway in the FP receptor function of this ocular tissue. Contraction-relaxation of smooth muscle alters the shape and stiffness of smooth muscle cells and MLC kinase, through myosin phosphorylation and dephosphorylation, has been shown to be involved in cytoskeletal remodeling, cytoskeletal alterations, and IOP lowering. In light of these reports and the findings presented here we suggest that alterations in the MLC kinase signaling pathway and its derived second messengers, which leads to changes in contraction-relaxation of the smooth muscles of the anterior segment, could facilitate aqueous humor outflow and thus contribute to the IOP-lowering effects of the FP-class PGs.

Degree of corneal anaesthesia after topical application of 0.4% oxybuprocaine hydrochloride and 0.5% proparacaine hydrochloride ophthalmic solution in clinically normal cattle.

PubMed

Little, W B; Jean, G St; Sithole, F; Little, E; Jean, K Yvorchuk-St

2016-06-01

The use of corneal anaesthesia is necessary for a range of clinical purposes. Therefore, we assessed and compared the efficacy of corneal anaesthesia after application of 0.4% oxybuprocaine hydrochloride and 0.5% proparacaine hydrochloride ophthalmic solution in clinically normal cattle. The 24 clinically normal cows were allocated into two groups. Cows in group 1 (n = 12) received 0.2 mL of 0.4% oxybuprocaine hydrochloride with fluorescein ophthalmic solution in one eye and 0.2 mL of sterile saline (0.9% NaCl) with fluorescein in the contralateral eye (control). Group 2 (n = 12) received 0.2 mL of 0.4% oxybuprocaine hydrochloride with fluorescein ophthalmic solution in one eye and 0.2 mL of 0.5% proparacaine hydrochloride with fluorescein in the contralateral eye (control). In each group, corneal touch threshold was determined by Cochet-Bonnet aesthesiometer for both eyes immediately prior to topical administration of solutions, at 1 min and 5 min after administration of topical solutions and every 5 min thereafter for a total of 75 min. Significant corneal anaesthesia was noted immediately following topical application of both oxybuprocaine and proparacaine as compared with controls, with maximal corneal anaesthesia noted 1 min after administration. Both oxybuprocaine and proparacaine produced significant corneal anaesthesia for the duration of the 75-min study. Neither oxybuprocaine hydrochloride nor proparacaine hydrochloride treatment resulted in visible adverse effects. There are limited data available demonstrating the efficacy and duration of corneal anaesthetic agents in cattle. Both oxybuprocaine hydrochloride and proparacaine hydrochloride should be considered practical options for providing corneal anaesthesia in cattle in a clinical setting. © 2016 Australian Veterinary Association.

Stability of pilocarpine hydrochloride and pilocarpine nitrate ophthalmic solutions submitted by U.S. hospitals.

PubMed

Kreienbaum, M A; Page, D P

1986-01-01

The stability of pilocarpine hydrochloride and pilocarpine nitrate ophthalmic solutions stored in hospital pharmacies across the United States was studied. Through a voluntary drug stability program, FDA selected 252 samples (representing 11 manufacturers) from pharmacies representing an adequate cross section of the country. The samples were analyzed for strength, identification, pH, and isopilocarpine and pilocarpic acid impurities. All samples of pilocarpine nitrate met USP requirements. Eight samples of pilocarpine hydrochloride had tablets that exceeded the USP upper limit for strength. All of these samples were in 1- and 2-mL bottles. The amount of isopilocarpine found ranged from 1 to 6.4%, and the amount of pilocarpic acid from 1.5 to 10.1%. Although pilocarpine salts in ophthalmic solution decompose into isopilocarpine and pilocarpic acid under various conditions of storage, an amount of pilocarpine is maintained that is within the compendial limits. However, there is a problem of evaporation from some of the 1- and 2-mL containers in which this product is supplied.

Bimatoprost 0.03% preservative-free ophthalmic solution versus bimatoprost 0.03% ophthalmic solution (Lumigan) for glaucoma or ocular hypertension: a 12-week, randomised, double-masked trial

PubMed Central

Day, Douglas G; Walters, Thomas R; Schwartz, Gail F; Mundorf, Thomas K; Liu, Charlie; Schiffman, Rhett M; Bejanian, Marina

2013-01-01

Background/Aim To evaluate efficacy and safety of bimatoprost 0.03% preservative-free (PF) ophthalmic solution versus bimatoprost 0.03% (Lumigan) ophthalmic solution for glaucoma or ocular hypertension. Methods In this double-masked, parallel-group study, patients were randomised to bimatoprost PF or bimatoprost for 12 weeks. The primary analysis for non-inferiority was change from baseline in worse eye intraocular pressure (IOP) in the per-protocol population at week 12. For equivalence, it was average eye IOP in the intent-to-treat population at each time point at weeks 2, 6 and 12. Results 597 patients were randomised (bimatoprost PF, n=302 and bimatoprost, n=295). The 95% CI upper limit for worse eye IOP change from baseline was <1.5 mm Hg at each week 12 time point, meeting prespecified non-inferiority criteria. The 95% CI upper limit for the treatment difference for average IOP was 0.69 mm Hg and the lower limit was −0.50 mm Hg at all follow-up time points (hours 0, 2 and 8 at weeks 2, 6 and 12), meeting equivalence criteria. Both treatments showed decreases in mean average eye IOP at all follow-up time points (p<0.001), were safe and well tolerated. Conclusions Bimatoprost PF is non-inferior and equivalent to bimatoprost in its ability to reduce IOP-lowering with a safety profile similar to bimatoprost. PMID:23743437

Bimatoprost 0.03%/timolol 0.5% preservative-free ophthalmic solution versus bimatoprost 0.03%/timolol 0.5% ophthalmic solution (Ganfort) for glaucoma or ocular hypertension: a 12-week randomised controlled trial

PubMed Central

Goldberg, Ivan; Gil Pina, Rafael; Lanzagorta-Aresti, Aitor; Schiffman, Rhett M; Liu, Charlie; Bejanian, Marina

2014-01-01

Aim To compare the efficacy and safety of single-dose bimatoprost 0.03%/timolol 0.5% preservative-free (PF) ophthalmic solution with bimatoprost 0.03%/timolol 0.5% ophthalmic solution in patients with open-angle glaucoma or ocular hypertension. Methods In this multicentre, randomised, parallel-group study, patients were randomised to bimatoprost/timolol PF or bimatoprost/timolol once daily in the morning for 12 weeks. Primary efficacy endpoints, reflecting differing regional regulatory requirements, included change from baseline in worse eye intraocular pressure (IOP) in the per-protocol population at week 12, and the average eye IOP at weeks 2, 6 and 12 in the intent-to-treat population. Results 561 patients were randomised (278 to bimatoprost/timolol PF; 283 to bimatoprost/timolol); 96.3% completed the study. Both treatment groups showed statistically and clinically significant mean decreases from baseline in worse eye IOP and in average eye IOP at all follow-up time points (p<0.001). Bimatoprost/timolol PF met all pre-established criteria for non-inferiority and equivalence to bimatoprost/timolol. Ocular adverse events were similar between treatment groups, with conjunctival hyperaemia being the most frequent. Most were mild or moderate in severity. Conclusions Bimatoprost/timolol PF demonstrated non-inferiority and equivalence in IOP lowering compared with bimatoprost/timolol, with no significant differences in safety and tolerability. Trial registration number NCT01177098. PMID:24667994

Reliable intraocular pressure measurement using automated radio-wave telemetry

PubMed Central

Paschalis, Eleftherios I; Cade, Fabiano; Melki, Samir; Pasquale, Louis R; Dohlman, Claes H; Ciolino, Joseph B

2014-01-01

Purpose To present an autonomous intraocular pressure (IOP) measurement technique using a wireless implantable transducer (WIT) and a motion sensor. Methods The WIT optical aid was implanted within the ciliary sulcus of a normotensive rabbit eye after extracapsular clear lens extraction. An autonomous wireless data system (AWDS) comprising of a WIT and an external antenna aided by a motion sensor provided continuous IOP readings. The sensitivity of the technique was determined by the ability to detect IOP changes resulting from the administration of latanoprost 0.005% or dorzolamide 2%, while the reliability was determined by the agreement between baseline and vehicle (saline) IOP. Results On average, 12 diurnal and 205 nocturnal IOP measurements were performed with latanoprost, and 26 diurnal and 205 nocturnal measurements with dorzolamide. No difference was found between mean baseline IOP (13.08±2.2 mmHg) and mean vehicle IOP (13.27±2.1 mmHg) (P=0.45), suggesting good measurement reliability. Both antiglaucoma medications caused significant IOP reduction compared to baseline; latanoprost reduced mean IOP by 10% (1.3±3.54 mmHg; P<0.001), and dorzolamide by 5% (0.62±2.22 mmHg; P<0.001). Use of latanoprost resulted in an overall twofold higher IOP reduction compared to dorzolamide (P<0.001). Repeatability was ±1.8 mmHg, assessed by the variability of consecutive IOP measurements performed in a short period of time (≤1 minute), during which the IOP is not expected to change. Conclusion IOP measurements in conscious rabbits obtained without the need for human interactions using the AWDS are feasible and provide reproducible results. PMID:24531415

Latanoprost and Dorzolamide for the Treatment of Pediatric Glaucoma: The Glaucoma Italian Pediatric Study (Gipsy), Design and Baseline Characteristics.

PubMed

Quaranta, Luciano; Biagioli, Elena; Galli, Francesca; Poli, Davide; Rulli, Eliana; Riva, Ivano; Hollander, Lital; Katsanos, Andreas; Longo, Antonio; Uva, Maurizio G; Torri, Valter; Weinreb, Robert N

2016-08-01

To investigate the efficacy of a treatment strategy with latanoprost and dorzolamide in primary pediatric glaucoma patients partially responsive to surgery. Single arm, prospective, interventional multicenter study. Primary pediatric glaucoma patients younger than 13 years after a single surgical procedure with IOP between 22 and 26 mmHg were considered eligible. At baseline, patients were allocated to latanoprost monotherapy once daily. Depending on intraocular pressure (IOP) reduction at first visit, the patients were allocated to one of three groups: continuation of latanoprost monotherapy, addition of dorzolamide twice daily, or switch to dorzolamide three times daily. The same approach for allocation in medication groups was used in all subsequent visits. Patients in the dorzolamide monotherapy group with IOP reduction <20% from baseline were considered non-responders and withdrawn. Study treatment and patient follow-up will continue for 3 years or until treatment failure. The primary endpoint is the percentage of responders. Secondary endpoints are time to treatment failure and frequency of adverse events. A total of 37 patients (69 eyes) were enrolled. The mean age was 4.0 ± 3.8 years, the female/male ratio was 1/1.7, and the majority of patients were Caucasian. Eighty percent of patients had bilateral glaucoma. Goniotomy was the most frequently performed surgery (38.6%), followed by trabeculotomy (22.8%), trabeculectomy (21.1%), and trabeculectomy plus trabeculotomy (17.5%). The baseline IOP was 23.6 ± 1.5 mmHg. The study population is representative of patients frequently encountered after the first surgery for primary pediatric glaucoma. The study will produce evidence on the medium-term efficacy of a defined pharmacological approach.

Treatment carryover impacts on effectiveness of intraocular pressure lowering agents, estimated by a discrete event simulation model.

PubMed

Denis, P; Le Pen, C; Umuhire, D; Berdeaux, G

2008-01-01

To compare the effectiveness of two treatment sequences, latanoprost-latanoprost timolol fixed combination (L-LT) versus travoprost-travoprost timolol fixed combination (T-TT), in the treatment of open-angle glaucoma (OAG) or ocular hypertension (OHT). A discrete event simulation (DES) model was constructed. Patients with either OAG or OHT were treated first-line with a prostaglandin, either latanoprost or travoprost. In case of treatment failure, patients were switched to the specific prostaglandin-timolol sequence LT or TT. Failure was defined as intraocular pressure higher than or equal to 18 mmHg at two visits. Time to failure was estimated from two randomized clinical trials. Log-rank tests were computed. Linear functions after log-log transformation were used to model time to failure. The time horizon of the model was 60 months. Outcomes included treatment failure and disease progression. Sensitivity analyses were performed. Latanoprost treatment resulted in more treatment failures than travoprost (p<0.01), and LT more than TT (p<0.01). At 60 months, the probability of starting a third treatment line was 39.2% with L-LT versus 29.9% with T-TT. On average, L-LT patients developed 0.55 new visual field defects versus 0.48 for T-TT patients. The probability of no disease progression at 60 months was 61.4% with L-LT and 65.5% with T-TT. Based on randomized clinical trial results and using a DES model, the T-TT sequence was more effective at avoiding starting a third line treatment than the L-LT sequence. T-TT treated patients developed less glaucoma progression.

Effect of latanoprost/timolol and dorzolamide/tiomolol on intraocular pressure after phacoemulsification surgery

PubMed Central

Erdogan, Haydar; Ozec, Ayse Vural; Caner, Cengiz; Toker, Mustafa Ilker; Arici, Mustafa Kemal; Topalkara, Aysen

2011-01-01

AIM To evalaute the effect of fixed-combination latanoprost 0.005%/timolol maleate 0.5% and dorzolamide hydrochloride 2%/timolol maleate 0.5% on postoperative intraocular pressure after phacoemulsification cataract surgery. METHODS This study is a prospective, randomized, double-masked and placebo-controlled. The study included 90 eyes of 90 patients which were scheduled to have phacoemulsification surgery. Patients were randomly assigned preoperatively to 1 of 3 groups (30 eyes of 30 patients). Two hour before surgery, the patients received one drop latanoprost/timolol (group 1), dorzolamide/timolol (group 2) and placebo (group 3, control group). The IOPs were measured at preoperative and postoperative 4, 8, and 24 hours. RESULTS The preoperative mean intraocular pressure was not statistically significant between both drug groups and control group. In group 1 and 2, the postoperative mean IOP [group1: (14.03±3.15)mmHg and group 2: (14.16±4.43)mmHg] at 24 hours were significantly lower than the control group [(16.93±3.70)mmHg, (P<0.05)]. In addition, the postoperative mean IOP of group 1 [(14.90±3.69)mmHg] at 8 hours was significantly lower than the control group [(17.70±3.89)mmHg, (P<0.05)], but there was no significant difference between group 2 [(16.16±5.23)mmHg] and control group at 8 hours (P>0.05). CONCLUSION When compared with placebo, the use of preoperative fixed combination of latanoprost/timolol and dorzolamide/timolol is an effective method for preventing intraocular pressure elevation in 24 hours after phacoemulsification surgery, but did not completely prevent IOP spikes. PMID:22553640

Effects of SofZia-preserved travoprost and benzalkonium chloride-preserved latanoprost on the ocular surface -- a multicentre randomized single-masked study.

PubMed

Aihara, Makoto; Oshima, Hiromi; Araie, Makoto

2013-02-01

To assess the effect of SofZia-preserved travoprost on ocular surface conditions in comparison with benzalkonium chloride (BAK)-preserved latanoprost. A prospective randomized multicentre single-masked comparative study. Patients with open-angle glaucoma or ocular hypertension who had been treated with BAK-preserved latanoprost 0.005% (Xalatan(®) ) monotherapy for at least 3 months. Patients were enrolled at 23 facilities. Patients were randomly divided into the X-X group, continuous use of Xalatan(®) , or the X-T group, switching from Xalatan(®) to SofZia-preserved travoprost 0.004% (TravatanZ(®) ), and followed for 3 months. The superficial punctate keratopathy (SPK), conjunctival epitheliopathy, hyperaemia, tear break-up time (TBUT) and intraocular pressure (IOP) were examined for each patient in a masked manner. Changes in the frequency of keratoconjunctival epitheliopathy were evaluated 3 months after study initiation. Intra- and intergroup comparisons of changes in SPK, conjunctival epitheliopathy, hyperaemia, TBUT and IOP were also carried out. Two hundred twenty patients participated and 215 completed the 3-month study. The frequency of keratoconjunctival epitheliopathy significantly decreased in the X-T group (p = 0.036) and the intergroup difference was also significant (p = 0.001). SPK scores and TBUT were significantly improved in the X-T group (p = 0.034, 0.049), also with significant intergroup differences in the cornea excluding the inferior area and TBUT. There were no significant intergroup differences in changes of the hyperaemia scores and the IOP reduction. Switching to SofZia-preserved travoprost after BAK-preserved latanoprost resulted in a lower incidence of keratoconjunctival epitheliopathy, especially in the cornea, with no clinically relevant changes in hyperaemia and IOP. © 2012 The Authors. Acta Ophthalmologica © 2012 Acta Ophthalmologica Scandinavica Foundation.

76 FR 28045 - Determination That XIBROM (Bromfenac Ophthalmic Solution) 0.09% Was Not Withdrawn From Sale for...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-13

... marketing for reasons other than safety or effectiveness. ANDAs that refer to XIBROM (bromfenac ophthalmic... Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and... withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve...

In vitro testing of thiolated poly(aspartic acid) from ophthalmic formulation aspects.

PubMed

Budai-Szű Cs, Mária; Horvát, Gabriella; Gyarmati, Benjámin; Szilágyi, Barnabás Áron; Szilágyi, András; Csihi, Tímea; Berkó, Szilvia; Szabó-Révész, Piroska; Mori, Michela; Sandri, Giuseppina; Bonferoni, Maria Cristina; Caramella, Carla; Csányi, Erzsébet

2016-08-01

Ocular drug delivery formulations must meet anatomical, biopharmaceutical, patient-driven and regulatory requirements. Mucoadhesive polymers can serve as a better alternative to currently available ophthalmic formulations by providing improved bioavailability. If all requirements are addressed, a polymeric formulation resembling the tear film of the eye might be the best solution. The optimum formulation must not have high osmotic activity, should provide appropriate surface tension, pH and refractive index, must be non-toxic and should be transparent and mucoadhesive. We would like to highlight the importance of in vitro polymer testing from a pharmaceutical aspect. We, therefore, carried out physical-chemical investigations to verify the suitability of certain systems for ophthalmic formulations. In this work, in situ gelling, mucoadhesive thiolated poly(aspartic acid)s were tested from ophthalmic formulation aspects. The results of preformulation measurements indicate that these polymers can be used as potential carriers in ophthalmic drug delivery.

Comparative studies of various hyaluronic acids produced by microbial fermentation for potential topical ophthalmic applications.

PubMed

Guillaumie, Fanny; Furrer, Pascal; Felt-Baeyens, Olivia; Fuhlendorff, Birgit L; Nymand, Søren; Westh, Peter; Gurny, Robert; Schwach-Abdellaoui, Khadija

2010-03-15

This work presents a comparative study of various hyaluronic acids (HA) produced by fermentation of either Bacillus subtilis or Streptococcus towards the selection of an optimal molecular weight (MW) HA for the preparation of topical ophthalmic formulations. The influence of HA MW on water binding capacity, sterile filtration, rheological properties, precorneal residence time and ocular tolerance of ophthalmic solutions was investigated. Molecular weight did not affect hydration of hyaluronic acid according to differential scanning calorimetry (DSC). In general, medium MW HA (0.6-1 MDa) resulted in solutions that were superior in terms of sterile filtration and kinematic viscosity requirements compared to high MW HA (>1 MDa). Moreover, all HA-based solutions exhibited well-defined viscoelastic properties that depend on MW. Gamma scintigraphic data indicated that HA MW at 0.1% concentration (w/v) and HA origin did not significantly affect the corneal residence time on rabbit eyes. A 0.3% solution of high MW HA had a prolonged residence time in the precorneal area compared to a medium MW HA at the same concentration. Finally, an in vivo ocular irritation test based on confocal laser scanning ophthalmoscopy (CLSO) conclusively showed the excellent tolerance of both Bacillus-derived HA and Streptococcus-derived HA after topical instillation onto the corneal surface. Overall, this comprehensive work highlights the superiority of medium MW hyaluronic acid for topical ophthalmic formulations based on their physico-chemical and biological properties, tolerance and handling. Such solutions are expected to enhance tear film stability, to allow for maximum comfort, and to exhibit high residence times, while being biocompatible and easy to sterile filter. (c) 2009 Wiley Periodicals, Inc.

The effect of the corneal epithelium on the intraocular penetration of fluoroquinolone ophthalmic solution.

PubMed

Fukuda, Masamichi; Inoue, Amane; Sasaki, Kazuyuki; Takahashi, Nobuo

2004-01-01

Pharmacokinetic studies of antibacterial agents for infectious eye diseases have usually been performed on normal rabbit eyes. In this study, the intraocular penetration of fluoroquinolone ophthalmic solutions was determined in normal rabbit eyes and in rabbit eyes that had the corneal epithelium intentionally removed. We determined the intraocular penetration of ofloxacin (OFLX), levofloxacin (LVFX), and norfloxacin (NFLX), fluoroquinolone ophthalmic solutions that are already on the market and undergoing clinical studies, by injecting 50 microl of each solution into the cul-de-sacs of rabbit eyes three times at 15-min intervals. The drug concentration at 10, 30, 60, 120, and 240 min after final instillation was determined by high-performance liquid chromatography. The maximum concentration in the aqueous humor of normal rabbit eyes was 2.09 +/- 1.56 microg/ml (60 min, OFLX), 2.57 +/- 1.00 microg/ml (30 min, LVFX), and 0.42 +/- 0.12 microg/ml (120 min, NFLX). The drug concentration in the aqueous humor of eyes with intentionally removed corneal epithelium was 12.50 +/- 5.62 microg/ml (30 min, OFLX), 9.02 +/- 2.45 microg/ml (60 min, LVFX), and 8.54 +/- 5.17 microg/ml (30 min, NFLX). The drug penetration of the eye drops into eyes with removed corneal epithelium was around 6 times (OFLX), 3.5 times (LVFX), and 20 times (NFLX) higher than the penetration into the eye with normal cornea. Among the pharmacokinetic parameters of the three ophthalmic solutions according to the one-compartment model, the maximum concentration in the aqueous and the area under the concentration-time curve in the aqueous tended to be higher in the eyes with intentionally removed corneal epithelia than in those with normal corneas.

Efficacy and safety of retinol palmitate ophthalmic solution in the treatment of dry eye: a Japanese Phase II clinical trial.

PubMed

Toshida, Hiroshi; Funaki, Toshinari; Ono, Koichi; Tabuchi, Nobuhito; Watanabe, Sota; Seki, Tamotsu; Otake, Hiroshi; Kato, Takuji; Ebihara, Nobuyuki; Murakami, Akira

2017-01-01

The purpose of this study was to investigate the efficacy and safety of the administration of retinol palmitate (VApal) ophthalmic solution (500 IU/mL) for the treatment of patients with dry eye. This study included 66 patients with dry eye. After a 2-week washout period, patients were randomized (1:1) into either a VApal ophthalmic solution or a placebo group, and a single drop of either solution was administered six times daily for 4 weeks. Efficacy measures were 12 subjective symptoms, rose bengal (RB) and fluorescein staining scores, tear film breakup time, and tear secretion. Safety measures included clinical blood and urine analyses and adverse event recordings. In comparisons of the two groups, the mean change in RB staining score from baseline was significantly lower in the VApal group at 2 and 4 weeks ( P <0.05 and P <0.01, respectively). Furthermore, the fluorescein clearance rate (fluorescein staining score) was significantly higher in the VApal group at 4 weeks ( P <0.05). The VApal group showed a significant improvement in blurred vision at 1 and 2 weeks ( P <0.01 and P <0.05, respectively), and the mean change in the total score for subjective symptoms from baseline was significantly lower in the VApal group at 1 week ( P <0.05). In before- and after-intervention comparisons, the fluorescein and RB staining scores showed improvement in both groups. Improvement was noted for 11 subjective symptoms in the VApal group and for seven symptoms in the placebo group. No significant differences in adverse events and reactions were found between the groups. VApal ophthalmic solution (500 IU/mL) is safe and effective for the treatment of patients with dry eye.

The effects of topical aqueous sirolimus on tear production in normal dogs and dogs with refractory dry eye.

PubMed

Spatola, Ronald; Nadelstein, Brad; Berdoulay, Andrew; English, Robert V

2018-05-01

To evaluate the effect of twice daily aqueous 0.02% sirolimus drops on tear production in normal dogs and dogs with refractory keratoconjunctivitis sicca (KCS). Two groups of dogs were studied. Ten normal dogs with no signs of ocular disease were administered topical 0.02% sirolimus ophthalmic solution in right eye, and a vehicle control in the left eye twice daily for 4 weeks. Complete ophthalmic examinations, including Schirmer tear test were performed weekly. Eighteen dogs with refractory KCS were randomly assigned to receive 0.02% sirolumus ophthalmic solution or 0.02% tacrolimus ophthalmic solution twice daily. Complete ophthalmic examinations were was performed at 2 and 6 weeks following treatment. Tear production in the sirolimus-treated eyes of normal dogs was greater when compared to vehicle controls with a mean difference over all time points of 3.46 mm (95% CI 1.17, 5.75; P = 0.006). After 4 weeks of treatment, the mean difference was 5 mm (95% CI 1.95, 8.05; P = 0.002). In dogs with refractory dry eye, 37.5% of eyes treated with sirolimus exhibited increased tear production >4 mm/min after 6 weeks of treatment, compared to 20% of eyes receiving tacrolimus (P = 0.433). One normal dog experienced topical irritation to both sirolimus and vehicle-treatment. Side effects were not reported in any treated eyes with chronic KCS. Topical 0.02% sirolimus might be an alternative treatment for canine patients with keratoconjunctivits sicca. The drug appears safe when applied topically in an aqueous suspension for up to 6 weeks. While initial results are promising, further studies are warranted. © 2017 American College of Veterinary Ophthalmologists.

Long-term topical application of preservative-free prostaglandin analogues evokes macrophage infiltration in the ocular adnexa.

PubMed

Trzeciecka, Anna; Paterno, J Jussi; Toropainen, Elisa; Koskela, Ali; Podracka, Lucia; Korhonen, Eveliina; Kauppinen, Anu; Kaarniranta, Kai; Smedowski, Adrian

2016-10-05

Success of the long-term glaucoma therapy and preservation of the visual function strongly depend on patients' compliance which may be affected by the inconvenience of treatment and its side effects. Recently, introduction of preservative-free anti-glaucoma agents has become an important step towards improved glaucoma care by eliminating the negative effects of preservatives on the eye surface. Although, newly developed eye drop formulations do not contain standard preservatives, they still can be harmful to ocular surface due to other excipients. In this study, we compared tolerability of commercial preservative-free (pf) prostaglandin analogues (pf tafluprost, pf latanoprost and pf bimatoprost) in long-term topical application in rabbits in vivo. We found that after eight weeks treatment, pf latanoprost was the worst tolerated among the tested drops. It expressed increased conjunctival redness and blinking frequency. Furthermore, it caused increased LDH release in the aqueous humour, infiltration of macrophages in the eyelids and visible defects in conjunctival goblet cells. However, we did not detect increased levels of inflammatory markers in the tear fluid or in the aqueous humour. Based on our study, we suspect that these negative effects are related to excipients included in pf latanoprost formulation. Copyright © 2016 Elsevier B.V. All rights reserved.

Optimising concentrations of antimicrobial agents in pharmaceutical preparations: Case of an oral solution of glycerol and an ophthalmic solution containing cysteamine.

PubMed

Chan Hew Wai, A; Becasse, P; Tworski, S; Pradeau, D; Planas, V

2014-11-01

In the context of current distrust of antimicrobial preservatives, the quantities of these substances in two pharmaceutical formulas were studied: an ophthalmic solution of cysteamine preserved benzalkonium chloride at 1mg/5mL and Glycerotone(®) preserved with sorbic acid at 0.1g/100g. The purpose of this work was to verify that a reduction of the quantities of preservative continues to fulfil the requirements for antimicrobial preservation. The Test of efficacy of antimicrobial preservation, section 5.1.3 of the 8th edition of the European Pharmacopoeia, was carried out on each formulation prepared with decreasing quantities of preservative. The results show that formulations whose preservative concentration was reduced by a factor of four remained compliant with standards. It is to be noted that in formulas without preservative, fungal growth was observed in both the solution of Glycerotone(®) and the ophthalmic solution containing cysteamine. Although there is no question that an antimicrobial preservative is necessary, the quantity of preservative can be reduced without deteriorating the quality of the pharmaceutical product but the minimal effective concentration remains to be determined. The formulations of many pharmaceutical products should therefore be examined in order to limit the quantities of preservative while continuing to guarantee patient's safety. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Effect of prophylactic topical hypotensive medications in reducing the incidence of postoperative ocular hypertension after phacoemulsification in dogs.

PubMed

Dees, D Dustin; Spahn, Kate J; Wagner, Lynsey Smith; Greller, Andrew; Paglia, Danielle; Armour, Micki D; Madsen, Richard

2017-11-01

To determine whether topical hypotensive medications prevent postoperative ocular hypertension (POH) after phacoemulsification. 52 client-owned dogs (88 eyes). Diabetic and nondiabetic dogs having undergone phacoemulsification were included in this retrospective study. The control group received no ocular hypotensive medications. The treatment groups received latanoprost, dorzolamide, or dorzolamide/timolol, beginning immediately after surgery, for 2-week duration. IOPs were obtained at initial examination followed by 4 h, 24 h, 7 days, and 14 days postoperatively. POH was defined as an IOP above 20 mmHg (POH20) or 25 mmHg (POH25). POH20 occurred in 33 of 87 eyes (37.93%), including 11 of 21 eyes (52.38%) in the control group, three of 23 eyes (13.04%) in the latanoprost group, eight of 15 eyes (53.33%) in the dorzolamide group, and 11 of 28 eyes (39.29%) in the dorzolamide/timolol group. Active treatment groups were compared to the control group, and the overall group effect was not significant (P = 0.11). POH25 occurred in 22 of 86 eyes (25.58%), including seven of 21 eyes (33.33%) in the control group, two of 23 eyes (8.70%) in the latanoprost group, five of 15 eyes (33.33%) in the dorzolamide group, and eight of 27 eyes (29.63%) in the dorzolamide/timolol group. Active treatment groups were compared to the control group, and the overall group effect was not significant (P = 0.31). Intraoperative use of intracameral tissue plasminogen activator significantly decreased the chances of POH25 (P = 0.0063). The latanoprost group had a substantially lower percentage of POH 20 and POH25 compared to the control and other active treatment groups, although statistical significance was not achieved. Intraoperative intracameral tissue plasminogen activator decreased the incidence of POH25. © 2017 American College of Veterinary Ophthalmologists.

Sustained Release of an Anti-Glaucoma Drug: Demonstration of Efficacy of a Liposomal Formulation in the Rabbit Eye

PubMed Central

Ang, Marcus; Darwitan, Anastasia; Foo, Selin; Zhen, Ma; Koo, Magdalene; Wong, Tina T.; Venkatraman, Subbu S.

2011-01-01

Topical medication remains the first line treatment of glaucoma; however, sustained ocular drug delivery via topical administration is difficult to achieve. Most drugs have poor penetration due to the multiple physiological barriers of the eye and are rapidly cleared if applied topically. Currently, daily topical administration for lowering the intra-ocular pressure (IOP), has many limitations, such as poor patient compliance and ocular allergy from repeated drug administration. Poor compliance leads to suboptimal control of IOP and disease progression with eventual blindness. The delivery of drugs in a sustained manner could provide the patient with a more attractive alternative by providing optimal therapeutic dosing, with minimal local toxicity and inconvenience. To investigate this, we incorporated latanoprost into LUVs (large unilamellar vesicles) derived from the liposome of DPPC (di-palmitoyl-phosphatidyl-choline) by the film hydration technique. Relatively high amounts of drug could be incorporated into this vesicle, and the drug resides predominantly in the bilayer. Vesicle stability monitored by size measurement and DSC (differential scanning calorimetry) analysis showed that formulations with a drug/lipid mole ratio of about 10% have good physical stability during storage and release. This formulation demonstrated sustained release of latanoprost in vitro, and then tested for efficacy in 23 rabbits. Subconjunctival injection and topical eye drop administration of the latanoprost/liposomal formulation were compared with conventional daily administration of latanoprost eye drops. The IOP lowering effect with a single subconjunctival injection was shown to be sustained for up to 50 days, and the extent of IOP lowering was comparable to daily eye drop administration. Toxicity and localized inflammation were not observed in any treatment groups. We believe that this is the first demonstration, in vivo, of sustained delivery to the anterior segment of the eye that is safe and efficacious for 50 days. PMID:21931735

A cost-effectiveness analysis of fixed-combination therapies in patients with open-angle glaucoma: a European perspective.

PubMed

Hommer, A; Wickstrøm, J; Friis, M M; Steeds, C; Thygesen, J; Ferreras, A; Gouws, P; Buchholz, P

2008-04-01

To compare the efficacy and cost implications of the use of the intraocular pressure-lowering prostaglandin analogues bimatoprost, travoprost, and latanoprost as fixed-combination therapies with timolol, a beta-adrenergic receptor antagonist. A decision analytic cost-effectiveness model was constructed. Since no head-to-head studies comparing the three treatment options exist, the analysis was based on an indirect comparison. Hence, the model was based on efficacy data from five randomized, controlled, clinical studies. The studies were comparable with respect to study design, time horizon, patient population and type of end point presented. The measure of effectiveness was the percentage reduction of the intraocular pressure level from baseline. The cost evaluated was the cost of medication and clinical visits to the ophthalmologist. All drug costs were market prices inclusive of value-added tax, and visit costs were priced using official physician fees. Cost-effectiveness analyses were carried out in five European countries: Spain, Italy, United Kingdom, Norway and Sweden. The time horizon for the analyses was 3 months. The analysis showed that fixed-combination bimatoprost/timolol was more effective and less costly than fixed-combination travoprost/timolol and fixed-combination latanoprost/timolol in three out of the five countries analyzed. In two countries, bimatoprost/timolol was less costly than latanoprost/timolol, and cost the same as travoprost/timolol. This cost-effectiveness analysis showed that the fixed combination of bimatoprost 0.03%/timolol 0.5% administered once daily was a cost-effective treatment option for patients with primary open-angle glaucoma. This study was limited by available clinical data: without a head-to-head trial, indirect comparisons were necessary. In the United Kingdom, Sweden, Norway, Italy, and Spain, from a health service viewpoint, bimatoprost/timolol was a slightly more effective as well as less costly treatment strategy when compared to both travoprost/timolol and latanoprost/timolol.

Comparison of the latanoprost 0.005%/timolol 0.5% + brinzolamide 1% versus dorzolamide 1%/timolol 0.5% + latanoprost 0.005%: a 12-week, randomized open-label trial

PubMed Central

Nakakura, Shunsuke; Tabuchi, Hitoshi; Baba, Yukio; Maruiwa, Futoshi; Ando, Nobuko; Kanamoto, Takashi; Kiuchi, Yoshiaki

2012-01-01

Objective To compare the safety and effectiveness of fixed-combination regimes (latanoprost– timolol and brinzolamide 1% compared to dorzolamide 1%/timolol and latanoprost) in open-angle glaucoma patients after switching from a combination of three topical antiglaucoma eye drops. Methods We conducted an open, randomized 12-week multicenter prospective study. We randomly allocated 39 patients who had been treated with three antiglaucoma eye drops (prostaglandin F2α analogues plus beta-blockers and carbonic anhydrase inhibitors) into two groups. Group A (n = 20) were treated with latanoprost–timolol and brinzolamide 1% therapy and Group B (n = 16) were treated with dorzolamide 1%/timolol and latanoprost. Thirty-six patients completed all 12 weeks of this study. The major clinical parameters measured were intraocular pressure (IOP), conjunctive hyperemia, superficial punctate keratopathy and hyperpigmentation of eyelid at baseline, 4, and 12 weeks. Additionally noted were adverse events and patient preferences, measured using a questionnaire at study initiation and at 12 weeks. Results At baseline, IOPs were (Group A: 14.1 ± 2.9 mmHg, B: 14.5 ± 2.9 mmHg; P = 0.658), (Group A: 13.8 ± 2.6 mmHg, B: 14.3 ± 2.8 mmHg; P = 0.715) at 4 weeks, and (Group A: 14.1 ± 2.7 mmHg, B: 14.2 ± 2.7 mmHg; P = 0.538) at 12 weeks. Among the groups, there was no significant difference at any time point after baseline (P = 0.923, 0.951, respectively). All adverse events were not remarkably different after therapy. In regards to patient preference before and after switching therapy, 10 patients (50%) in Group A and 10 patients (63%) in Group B preferred using fixed-combination eye drop therapy. Conclusions Effectiveness and safety were maintained in both groups after switching therapy. Overall, patients generally preferred using a fixed-combination therapy. PMID:22419858

FOXC1 Regulates Expression of Prostaglandin Receptors Leading to an Attenuated Response to Latanoprost.

PubMed

Doucette, Lance P; Footz, Tim; Walter, Michael A

2018-05-01

This study examines the effect of FOXC1 on the prostaglandin pathway in order to explore FOXC1's role in the prostaglandin-resistant glaucoma phenotype commonly seen in Axenfeld-Rieger syndrome. Binding and transcriptional activity of FOXC1 to the gene coding for the EP3 prostaglandin receptor (PTGER3) were evaluated through ChIP-qPCR and luciferase-based assays. Immortalized trabecular meshwork cells (TM1) and HeLa cells had FOXC1 mRNA reduced via siRNA interference. qPCR and Western blot experiments were conducted to examine the changes in prostaglandin receptor expression brought about by lowered FOXC1. TM1 cells were then treated with 10 μM latanoprost acid and/or an siRNA for FOXC1. The expression of fibronectin and matrix metalloproteinase 9 were evaluated via qPCR in each treatment condition. ChIP-qPCR and luciferase experiments confirmed that FOXC1 binds to and activates transcription of the EP3 gene prostaglandin receptor. qPCR and Western experiments in HeLa and TM1 cells showed that FOXC1 siRNA knockdown results in significantly lowered EP3 levels (protein and RNA). In addition, RNA levels of the other prostaglandin receptor genes EP1 (PTGER1), EP2 (PTGER2), EP4 (PTGER4), and FP (PTGFR) were altered when FOXC1 was knocked down in TM1 and HeLa cells. Analysis of fibronectin expression in TM1 cells after treatment with 10 μM latanoprost acid showed a statistically significant increase in expression; this increase was abrogated by cotreatment with a siRNA for FOXC1. We show the abrogation of latanoprost signalling when FOXC1 is knocked down via siRNA in a trabecular meshwork cell line. We propose that the lower levels of active FOXC1 in Axenfeld-Rieger syndrome patients with glaucoma account for the lack of response to prostaglandin-based medications.

21 CFR 800.10 - Contact lens solutions; sterility.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Contact lens solutions; sterility. 800.10 Section...) MEDICAL DEVICES GENERAL Requirements for Specific Medical Devices § 800.10 Contact lens solutions... ophthalmic use, including contact lens solutions, should be sterile. It is further evident that such...

21 CFR 800.10 - Contact lens solutions; sterility.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Contact lens solutions; sterility. 800.10 Section...) MEDICAL DEVICES GENERAL Requirements for Specific Medical Devices § 800.10 Contact lens solutions... ophthalmic use, including contact lens solutions, should be sterile. It is further evident that such...

21 CFR 800.10 - Contact lens solutions; sterility.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Contact lens solutions; sterility. 800.10 Section...) MEDICAL DEVICES GENERAL Requirements for Specific Medical Devices § 800.10 Contact lens solutions... ophthalmic use, including contact lens solutions, should be sterile. It is further evident that such...

21 CFR 800.10 - Contact lens solutions; sterility.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Contact lens solutions; sterility. 800.10 Section...) MEDICAL DEVICES GENERAL Requirements for Specific Medical Devices § 800.10 Contact lens solutions... ophthalmic use, including contact lens solutions, should be sterile. It is further evident that such...

21 CFR 800.10 - Contact lens solutions; sterility.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Contact lens solutions; sterility. 800.10 Section...) MEDICAL DEVICES GENERAL Requirements for Specific Medical Devices § 800.10 Contact lens solutions... ophthalmic use, including contact lens solutions, should be sterile. It is further evident that such...

Influence of Ophthalmic Solutions on Tear Components.

PubMed

Shigeyasu, Chika; Yamada, Masakazu; Akune, Yoko

2016-11-01

Tear fluids are a mixture of secretions derived from lacrimal glands, accessory lacrimal glands, conjunctiva, and meibomian glands. Compositional changes to tears occur in the normal state and during ocular surface disease, such as dry eye conditions. We have investigated compositional changes to tears after topical application of ophthalmic solutions, with regard to tear-specific proteins (secretory immunoglobulin A, lactoferrin, lipocalin-1, and lysozyme) and ocular surface mucin in normal and dry eye conditions using high-performance liquid chromatography. After application of saline solution (0.9% sodium chloride) in normal subjects, transient but significant decreases in all tear components were observed. The recovery of protein concentrations took up to 30 minutes and lasted longer when the saline solution was applied more frequently. When applying ophthalmic solutions, a balance between washout and dilutional effects should be considered in addition to the therapeutic effect. Investigation of the effect of diquafosol solution (3%) in normal subjects revealed a significant increase in sialic acid concentration, a marker of ocular mucin, at 5 minutes after application, whereas a significant decrease was observed with saline. This result indicates the accelerated secretion of mucin from ocular tissues induced by diquafosol. A clinical study to determine the efficacy of diquafosol in patients with dry eye revealed improvements in tear breakup time, keratoconjunctival staining scores, and Schirmer test score, accompanied by an increase in sialic acid concentration in tears. Investigating normal and dry eye conditions through tear analysis may clarify the pathophysiology of dry eye conditions and support the efficacy of treatments.

Antimicrobial activity of a new preservative for multiuse ophthalmic solutions.

PubMed

Ghelardi, Emilia; Celandroni, Francesco; Gueye, Sokhna A; Salvetti, Sara; Campa, Mario; Senesi, Sonia

2013-01-01

The aim of this study was to examine the antimicrobial activity and the preservative efficacy of a novel preservative solution containing sodium hydroxymethyl glycinate (SHMG) and edetate disodium (EDTA), which is used for preservation of some commercial ophthalmic formulations. In vitro susceptibility assays were performed against several gram-positive (Staphylococcus aureus, Staphylococcus epidermidis, and Bacillus cereus) and gram-negative (Escherichia coli and Pseudomonas aeruginosa) bacteria representative of the microbial flora of epithelial surfaces or colonizing the conjunctiva, as well as against Candida albicans and Aspergillus niger. Using different concentrations of SHMG alone or in combination with EDTA, the minimal inhibitory and microbicidal concentrations against these organisms were assessed. In addition, 8 brands of multidose eye drops containing 0.002% SHMG and 0.1% EDTA as preservative were tested for antimicrobial activity using the antimicrobial effectiveness test recommended by the international pharmacopoeias. The minimal inhibitory and bactericidal/fungicidal concentration values of SHMG ranged from 0.0025% to 0.0125% for bacteria and from 0.125% to 0.50% for mold and yeast. Susceptibility testing demonstrated that the addition of EDTA substantially increased the SHMG activity against all bacterial and fungal strains. The preservative effectiveness test was applied to commercial eye drops. All the drop solutions met the criteria reported by the U.S. Pharmacopeia for parenteral and ophthalmic preparations. All products also satisfied the major acceptance criteria of the European Pharmacopeia with respect to the antifungal activity. With regard to the antibacterial activity, the less-stringent criteria of the European Pharmacopeia were fulfilled. The present study demonstrates the efficacy of a novel preservative for ophthalmic solutions (SHMG/EDTA) and its activity in protecting selected commercial artificial tears against microbial contamination.

[Hypertension secondary to treatment with latanoprost].

PubMed

Santos-Bueso, E; Sáenz-Francés, F; Palmero-Fernández, L; García-Sáenz, S; Martínez-de-la-Casa, J M; García-Feijoo, J; García-Sánchez, J

2015-01-01

An 80 year old woman operated on by trabeculectomy for primary open-angle glaucoma due to increased pressure, who started treatment with latanoprost. Monitoring of blood pressure (BP) showed a statistically significant increase in both systolic and diastolic BP, coinciding with the use of topical hypotensive, which resolved by voluntarily suspending treatment, thus increasing again to reintroduce the prostaglandin. Prostaglandin analogs reduce intraocular pressure to produce vasodilation of the episcleral and ciliary arteries, increasing the outflow of aqueous humor. Cardiovascular effects are rare, but have been described by the vasoconstrictor effect that can trigger the reversible increase in BP, as in this case. Copyright © 2013 Sociedad Española de Oftalmología. Published by Elsevier España, S.L.U. All rights reserved.

Aqueous penetration and biological activity of moxifloxacin 0.5% ophthalmic solution and gatifloxacin 0.3% solution in cataract surgery patients.

PubMed

Kim, Dianne H; Stark, Walter J; O'Brien, Terrence P; Dick, James D

2005-11-01

To measure the achievable perioperative aqueous concentration of the commercially available topically administered fourth generation fluoroquinolones, moxifloxacin 0.5% ophthalmic solution, and gatifloxacin 0.3% ophthalmic solution, and to correlate this concentration with the agents' biological efficacy in the aqueous humor of patients undergoing routine cataract surgery. Prospective, randomized, parallel, double-masked, clinical trial. Fifty patients undergoing cataract extraction. Patients (n = 25) were given perioperative topical moxifloxacin 0.5% or topical gatifloxacin 0.3% (n = 25). One drop of antibiotic was administered every 10 minutes for 4 doses beginning 1 hour prior to surgery. Aqueous humor was sampled via paracentesis and antibiotic concentrations were determined using validated high performance liquid chromatography (HPLC) procedures. Dilution analyses were performed to determine the biological efficacy of the agents in the aqueous against Staphylococcus epidermidis, the most common cause of postcataract endophthalmitis. Aqueous humor antibiotic concentrations were measured using HPLC and microdilution bioassay techniques. Biological activity was measured as minimal inhibitory dilution and minimal bactericidal dilution. Aqueous humor concentrations for moxifloxacin via HPLC analysis were 1.80 (+/-1.21) microg/ml, whereas those for gatifloxacin were 0.48 (+/-0.34) microg/ml. This 3.8-fold difference in aqueous humor antibiotic concentrations was statistically significant (P = 0.00003). Similarly, the biological dilution analysis of the aqueous humor samples showed that moxifloxacin attained an estimated activity of 2.1 microg/ml, whereas the gatifloxacin activity was approximately 0.4 mug/ml, which represented a 4.9-fold difference. This study demonstrated that after topically administered perioperative antibiotics with cataract surgery, moxifloxacin 0.5% ophthalmic solution achieved a statistically significantly higher concentration in aqueous humor compared with gatifloxacin (P = 0.00003). Results from the broth dilution analysis showed that moxifloxacin 0.5% was biologically more active against S. epidermidis than gatifloxacin 0.3% in aqueous humor after topical application. There were no adverse events reported, and incision wounds healed quickly and as expected.

Omni-focal refractive focus correction technology as a substitute for bi/multi-focal intraocular lenses, contact lenses, and spectacles

NASA Astrophysics Data System (ADS)

Ben Yaish, Shai; Zlotnik, Alex; Raveh, Ido; Yehezkel, Oren; Belkin, Michael; Lahav, Karen; Zalevsky, Zeev

2009-02-01

We present novel technology for extension in depth of focus of imaging lenses for use in ophthalmic lenses correcting myopia, hyperopia with regular/irregular astigmatism and presbyopia. This technology produces continuous focus without appreciable loss of energy. It is incorporated as a coating or engraving on the surface for spectacles, contact or intraocular lenses. It was fabricated and tested in simulations and in clinical trials. From the various testing this technology seems to provide a satisfactory single-lens solution. Obtained performance is apparently better than those of existing multi/bifocal lenses and it is modular enough to provide solution to various ophthalmic applications.

Retinal protective effects of topically administered agmatine on ischemic ocular injury caused by transient occlusion of the ophthalmic artery

PubMed Central

Hong, S.; Hara, H.; Shimazawa, M.; Hyakkoku, K.; Kim, C.Y.; Seong, G.J.

2012-01-01

Agmatine, an endogenous polyamine and putative neuromodulator, is known to have neuroprotective effects on various neurons in the central nervous system. We determined whether or not topically administered agmatine could reduce ischemic retinal injury. Transient ocular ischemia was achieved by intraluminal occlusion of the middle cerebral artery of ddY mice (30-35 g) for 2 h, which is known to also induce occlusion of the ophthalmic artery. In the agmatine group (N = 6), a 1.0 mM agmatine-containing ophthalmic solution was administered four times daily for 2 weeks before occlusion. In the control group (N = 6), a 0.1% hyaluronic acid ophthalmic solution was instilled at the same times. At 22 h after reperfusion, the eyeballs were enucleated and the retinal sections were stained by terminal deoxynucleotidyl transferase dUTP nick-end labeling (TUNEL). Transient ocular ischemia induced apoptosis of retinal cells in the entire retinal layer, and topically administered agmatine can significantly reduce this ischemic retinal injury. The proportion of apoptotic cells was definitely decreased (P < 0.001; Kruskal-Wallis test). Overall, we determined that topical agmatine application effectively decreases retinal damage in an in vivo ocular ischemic injury model. This implies that agmatine is a good candidate as a direct neuroprotective agent for eyes with ocular ischemic diseases. PMID:22331138

The effects of 2% rebamipide ophthalmic solution on the tear functions and ocular surface of the superoxide dismutase-1 (sod1) knockout mice.

PubMed

Ohguchi, Takeshi; Kojima, Takashi; Ibrahim, Osama M; Nagata, Taeko; Shimizu, Takahiko; Shirasawa, Takuji; Kawakita, Tetsuya; Satake, Yoshiyuki; Tsubota, Kazuo; Shimazaki, Jun; Ishida, Susumu

2013-11-21

To investigate the efficacy of 2% rebamipide ophthalmic solution on the tear functions and ocular surface status of the superoxide dismutase-1(Sod1(-/-)) mice. Two percent Rebamipide ophthalmic solution was applied to 40-week-old male Sod1(-/-) and wild-type (WT) mice four times a day for 2 weeks. We examined the cytokine concentrations in the tear fluid (by CytoBead assay), tear film break-up time, amount of tear production, and expressions of mucins 1, 4, and 5AC, by RT-PCR. We also performed vital staining of the ocular surface, PAS staining for muc5AC, and immunohistochemical stainings for 4-hydroxy-2-nonenal (4-HNE), 8-hydroxy-2'-deoxyguanosine (8-OHdG), in the conjunctiva to compare the results before and after rebamipide instillations. The tear functions and ocular surface epithelial damage scores were significantly worse in the Sod1(-/-) than in the WT mice. Application of 2% rebamipide for 2 weeks significantly improved the tear film break-up time, the amount of tear production, and the corneal epithelial damage scores, which also significantly increased the conjunctival goblet cell density and muc5 mRNA expression, in the Sod1(-/-) mice. The mean IL-6, IL-17, TNF-α, and IFN-γ levels in the tear fluid were reduced significantly along with a significant decrease in the density of cells positive for 4-HNE and 8-OHdG in the conjunctiva. Two percent Rebamipide ophthalmic solution significantly improved the tear stability and corneal epithelial damage, and enhanced the expression of muc5 mRNA on the ocular surface. We also observed anti-inflammatory effects in the tear film together with antioxidative effects in the conjunctiva, suggesting the efficacy of rebamipide in age-related dry eye disease attributable to SOD1 knockout.

Effect of gellan gum on the thermogelation property and drug release profile of Poloxamer 407 based ophthalmic formulation.

PubMed

Dewan, Mitali; Sarkar, Gunjan; Bhowmik, Manas; Das, Beauty; Chattoapadhyay, Atis Kumar; Rana, Dipak; Chattopadhyay, Dipankar

2017-09-01

The effect of gellan gum on the gelation behavior and in-vitro release of a specific drug named pilocarpine hydrochloride from different ophthalmic formulations based on poloxamer 407 is examined. The mixture of 0.3wt% gellan gum and 18wt% poloxamer (PM) solutions show a considerable increase in gel strength in physiological condition. Gel dissolution rate from PM based formulation is significantly decreased due to the addition of gellan gum. FTIR spectra analysis witnesses an interaction in between OH groups of two polymers which accounts for lowering in gelation temperature of PM-gellan gum based formulations. It is also observed from the cryo-SEM study that the pore size of PM gel decreases with an addition of gellan gum and in-vitro release studies indicate that PM-gellan gum based formulation retain drug better than the PM solution alone. Therefore, the developed formulation has the potential to be utilized as an in-situ ophthalmic drug carrier. Copyright © 2017 Elsevier B.V. All rights reserved.

Effects of topical diquafosol pretreatment on intraoperative corneal wetting.

PubMed

Miyake, Goichiro; Ota, Ichiro; Miyake, Kensaku; Zako, Masahiro; Iwaki, Masayoshi

2014-10-01

To examine the effects of pretreatment with diquafosol 3.0% ophthalmic solution on corneal surface wetting during cataract surgery with intraocular lens (IOL) implantation in cases of senile cataract. Shohzankai Medical Foundation, Miyake Eye Hospital, Nagoya, Japan. Prospective randomized single-masked comparative study. Phacoemulsification and IOL implantation were performed in eyes with senile cataract. After a 2-week washout period, patients were randomly assigned to receive 1 drop of diquafosol 3.0% ophthalmic solution or artificial tears 6 times daily for 4 weeks before surgery. The main outcome measure, termed the corneal wetting property, was the time between when a clear image of the operating microscope light source appeared just after the corneal surface was irrigated with a balanced salt solution and the time at which that image began to blur. The study enrolled 51 patients (76 eyes). The mean time to corneal wetting was 50.1 seconds ± 10.8 (SD) in the diquafosol group and 45.3 ± 9.2 seconds in the artificial tears group. The difference between the 2 groups was statistically significant (P<.029). Four-week pretreatment with diquafosol 3.0% ophthalmic solution in patients with senile cataract scheduled for cataract surgery with IOL implantation was effective in enhancing the intraoperative corneal surface wetting property, which suggests improved optical clarity during surgery. No author has a financial or proprietary interest in any material or method mentioned. Copyright © 2014 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

Effects of Four Formulations of Prostaglandin Analogs on Eye Surface Cells. A Comparative Study

PubMed Central

Pérez-Roca, Fernando; Rodrigo-Morales, Esther; Garzón, Ingrid; Oliveira, Ana-Celeste; Martín-Piedra, Miguel-Ángel; Carriel, Víctor; Ortiz-Pérez, Ana-Isabel; Sánchez-Montesinos, Indalecio; Campos, Antonio; Alaminos, Miguel

2015-01-01

We evaluated the cytotoxic effects of four prostaglandin analogs (PGAs) used to treat glaucoma. First we established primary cultures of conjunctival stromal cells from healthy donors. Then cell cultures were incubated with different concentrations (0, 0.1, 1, 5, 25, 50 and 100%) of commercial formulations of bimatoprost, tafluprost, travoprost and latanoprost for increasing periods (5 and 30 min, 1 h, 6 h and 24 h) and cell survival was assessed with three different methods: WST-1, MTT and calcein/AM-ethidium homodimer-1 assays. Our results showed that all PGAs were associated with a certain level of cell damage, which correlated significantly with the concentration of PGA used, and to a lesser extent with culture time. Tafluprost tended to be less toxic than bimatoprost, travoprost and latanoprost after all culture periods. The results for WST-1, MTT and calcein/AM-ethidium homodimer-1 correlated closely. When the average lethal dose 50 was calculated, we found that the most cytotoxic drug was latanoprost, whereas tafluprost was the most sparing of the ocular surface in vitro. These results indicate the need to design novel PGAs with high effectiveness but free from the cytotoxic effects that we found, or at least to obtain drugs that are functional at low dosages. The fact that the commercial formulation of tafluprost used in this work was preservative-free may support the current tendency to eliminate preservatives from eye drops for clinical use. PMID:26067827

78 FR 12763 - Pediatric Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-25

... [Immune Globulin Subcutaneous (Human), 20% Liquid], INOMAX (nitric oxide), INVEGA (paliperidone), KEDBUMIN... (moxifloxacin ophthalmic solution 0.5%), NATROBA (spinosad), NEXIUM (esomeprazole magnesium), NEXIUM IV...

21 CFR 524.981e - Fluocinolone acetonide, dimethyl sulfoxide otic solution.

Code of Federal Regulations, 2012 CFR

2012-04-01

... HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS § 524.981e Fluocinolone acetonide, dimethyl sulfoxide otic solution. (a... sensitivity testing, and the use of the appropriate antimicrobial agent. As with any corticosteroid, animals...

21 CFR 524.981e - Fluocinolone acetonide, dimethyl sulfoxide otic solution.

Code of Federal Regulations, 2013 CFR

2013-04-01

... HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS § 524.981e Fluocinolone acetonide, dimethyl sulfoxide otic solution. (a... sensitivity testing, and the use of the appropriate antimicrobial agent. As with any corticosteroid, animals...

21 CFR 524.981e - Fluocinolone acetonide, dimethyl sulfoxide otic solution.

Code of Federal Regulations, 2011 CFR

2011-04-01

... HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS § 524.981e Fluocinolone acetonide, dimethyl sulfoxide otic solution. (a... sensitivity testing, and the use of the appropriate antimicrobial agent. As with any corticosteroid, animals...

21 CFR 524.981e - Fluocinolone acetonide, dimethyl sulfoxide otic solution.

Code of Federal Regulations, 2010 CFR

2010-04-01

... HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS § 524.981e Fluocinolone acetonide, dimethyl sulfoxide otic solution. (a... sensitivity testing, and the use of the appropriate antimicrobial agent. As with any corticosteroid, animals...

Vehicle effects in ophthalmic bioavailability: an evaluation of polymeric inserts containing pilocarpine.

PubMed

Saettone, M F; Giannaccini, B; Chetoni, P; Galli, G; Chiellini, E

1984-04-01

A series of polymeric ophthalmic inserts containing pilocarpine were formulated with four different types of polyvinyl alcohol, PVA, and two types of hydroxypropylcellulose. Pilocarpine was present as the nitrate, or as the salt with polyacrylic acid, PAA. In-vivo miosis vs time experiments on albino rabbits, showed that all inserts increased significantly the bioavailability of pilocarpine, with respect to a standard solution of pilocarpine nitrate. Two PVA inserts, containing the PAA-salt of pilocarpine, were particularly effective. The preparations were also submitted to in-vitro release tests and to differential scanning calorimetry, to ascertain the release mechanism, and to verify, via the thermal behaviour, possible interactions between drug and polymers. The chemical and physiochemical factors, most likely to influence the ophthalmic bioavailability of pilocarpine from the present preparations, are briefly reviewed.

Effect of gatifloxacin ophthalmic solution 0.3% on human corneal endothelial cell density and aqueous humor gatifloxacin concentration.

PubMed

Price, Marianne O; Quillin, Clorissa; Price, Francis W

2005-07-01

To evaluate the effect of gatifloxacin ophthalmic solution 0.3% (Zymar, Allergan, Inc., Irvine, CA, USA) on corneal endothelial cell density and morphology and to measure gatifloxacin penetration into aqueous humor. This was a single-center, open-label clinical study. Ten patients undergoing standard cataract surgery and 20 nonsurgical subjects instilled gatifloxacin 0.3% four times per day for 2 days, then every 10 min for 1 hr on the third day (the surgery day for the cataract patients). Corneal endothelial cells were counted using noncontact specular microscopy. Anterior chamber fluid was withdrawn from the surgical patients, and the gatifloxacin concentration was quantified by high-pressure liquid chromatography. Baseline endothelial cell counts (mean +/- SD) were 2400 +/- 442 in the surgical group and 2520 +/- 212 in the nonsurgical group. The mean differences from baseline 1 hr after the last dose of gatifloxacin 0.3% were -51 +/- 213 (p = 0.23) in the surgical group and -7 +/- 150 (p = 0.42) in the nonsurgical group. In the nonsurgical group, the mean difference from baseline 3 weeks after the last dose was 18 +/- 147 (p = 0.71). The mean concentration (+/- SD) of gatifloxacin in aqueous humor was 1.26 +/- 0.55 microg/ml. A preoperative, prophylactic course of gatifloxacin 0.3% ophthalmic solution did not significantly affect endothelial cell density or morphology, while meaningful drug concentration was achieved in the aqueous humor.

Ocular toxicity of beta-blockers and benzalkonium chloride in pigmented rabbits: electrophysiological and morphological studies.

PubMed

Chou, A; Hori, S; Takase, M

1985-01-01

Subconjunctival injection of 0.2 ml of the following solutions was carried out once a day for two weeks in the albino and pigmented rabbit: commercial 0.5% timolol or 1% befunolol ophthalmic solutions, both containing benzalkonium chloride, and also these drug solutions containing no preservative, ophthalmic base solutions containing benzalkonium chloride, physiological saline solution or phosphate buffer solution. One week after daily injections of the commercial drug solutions or base solutions with benzalkonium chloride, the electroretinogram (ERG) showed a marked reduction in the a- and b-wave amplitudes in the pigmented rabbit, but the ERG changes were slight in the albino rabbit. After two weeks of injections, histological studies of the pigmented rabbit eyes revealed retinal detachment, visual cell loss and atrophy of the retinal pigment epithelium and choroid; the changes in the albino rabbit eyes were minimal. Injections of the beta-blockers containing no benzalkonium resulted in no significant changes in the ERG or in the tissue structures of all rabbits. Injections of only physiological saline or phosphate buffer had no deleterious effects. Therefore, the ocular toxicity of the beta-blockers was thought to be minor and the toxic effects seen in this study were thought to be due to benzalkonium chloride, which possibly accumulates in the ocular pigments.

Diffusion-Based Design of Multi-Layered Ophthalmic Lenses for Controlled Drug Release

PubMed Central

Pimenta, Andreia F. R.; Serro, Ana Paula; Paradiso, Patrizia; Saramago, Benilde

2016-01-01

The study of ocular drug delivery systems has been one of the most covered topics in drug delivery research. One potential drug carrier solution is the use of materials that are already commercially available in ophthalmic lenses for the correction of refractive errors. In this study, we present a diffusion-based mathematical model in which the parameters can be adjusted based on experimental results obtained under controlled conditions. The model allows for the design of multi-layered therapeutic ophthalmic lenses for controlled drug delivery. We show that the proper combination of materials with adequate drug diffusion coefficients, thicknesses and interfacial transport characteristics allows for the control of the delivery of drugs from multi-layered ophthalmic lenses, such that drug bursts can be minimized, and the release time can be maximized. As far as we know, this combination of a mathematical modelling approach with experimental validation of non-constant activity source lamellar structures, made of layers of different materials, accounting for the interface resistance to the drug diffusion, is a novel approach to the design of drug loaded multi-layered contact lenses. PMID:27936138

Visual acuity estimation from simulated images

NASA Astrophysics Data System (ADS)

Duncan, William J.

Simulated images can provide insight into the performance of optical systems, especially those with complicated features. Many modern solutions for presbyopia and cataracts feature sophisticated power geometries or diffractive elements. Some intraocular lenses (IOLs) arrive at multifocality through the use of a diffractive surface and multifocal contact lenses have a radially varying power profile. These type of elements induce simultaneous vision as well as affecting vision much differently than a monofocal ophthalmic appliance. With myriad multifocal ophthalmics available on the market it is difficult to compare or assess performance in ways that effect wearers of such appliances. Here we present software and algorithmic metrics that can be used to qualitatively and quantitatively compare ophthalmic element performance, with specific examples of bifocal intraocular lenses (IOLs) and multifocal contact lenses. We anticipate this study, methods, and results to serve as a starting point for more complex models of vision and visual acuity in a setting where modeling is advantageous. Generating simulated images of real- scene scenarios is useful for patients in assessing vision quality with a certain appliance. Visual acuity estimation can serve as an important tool for manufacturing and design of ophthalmic appliances.

21 CFR 524.1982 - Proparacaine hydrochloride ophthalmic solution.

Code of Federal Regulations, 2012 CFR

2012-04-01

... used as an anesthetic in cauterization of corneal ulcers, removal of foreign bodies and sutures from the cornea, and measurement of intraocular pressure (tonometry) when glaucoma is suspected. Local...

21 CFR 524.1982 - Proparacaine hydrochloride ophthalmic solution.

Code of Federal Regulations, 2013 CFR

2013-04-01

... used as an anesthetic in cauterization of corneal ulcers, removal of foreign bodies and sutures from the cornea, and measurement of intraocular pressure (tonometry) when glaucoma is suspected. Local...

The efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zero-to-trace anterior chamber cell severity following cataract surgery

PubMed Central

Silverstein, Steven M; Jackson, Mitchell A; Goldberg, Damien F; Muñoz, Mauricio

2014-01-01

Purpose To evaluate the efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zero-to-trace (0–5 cells) anterior chamber cells, following cataract surgery with posterior chamber intraocular lens implantation. Methods The study designed employed two Phase III, double-masked, placebo-controlled, multicenter clinical trials of 440 subjects, randomized to either bromfenac ophthalmic solution 0.07% (n=222) or placebo (n=218). Subjects self-dosed once daily, beginning 1 day before undergoing cataract surgery with intraocular lens implantation (day –1) and again on the day of surgery (day 0) and for 14 days postoperatively. Follow-up was on days 1, 3, 8, and 15. The outcome measures included the percentage of subjects with zero-to-trace anterior chamber cells at each visit, as determined by the percentage of subjects with ≤5 anterior chamber cells, overall anterior chamber cell grades, and summed ocular inflammation score (SOIS) (combined anterior chamber cell and flare scores). Results The proportion of subjects with zero-to-trace anterior chamber cells was significantly higher in the bromfenac 0.07% group compared with the placebo group as early as day 3 (P=0.0007), continued at day 8 (P<0.0001), and through day 15 (P<0.0001). At day 15, 80.2% of subjects in the bromfenac 0.07% group achieved zero-to-trace anterior chamber cells compared with 47.2% of subjects who did so in the placebo group. The overall anterior chamber cell scores were significantly lower in the bromfenac 0.07% group compared with the placebo group at days 3, 8, and 15 (P<0.0001 at each visit). The SOIS were also significantly lower in the bromfenac group compared with the placebo group at days 3, 8, and 15 (P<0.0001 at each visit). Conclusion Bromfenac ophthalmic solution 0.07%, dosed once daily was clinically effective in achieving zero-to-trace anterior chamber cell severity after cataract surgery and was superior to placebo in all anterior chamber cell severity and inflammation outcome measures. PMID:24876763

Formulation and Stability of Solutions.

PubMed

Akers, Michael J

2016-01-01

Ready-to-use solutions are the most preferable and most common dosage forms for injectable and topical ophthalmic products. Drugs formulated as solution almost always have chemical and physical stability challenges as well as solubility limitations and the need to prevent inadvertent microbial contamination issues. This article, which takes us through a discussion of optimizing the physical stability of solutions, represents the first of a series of articles discussing how these challenges and issues are addressed.

Development of an Aqueous Ophthalmic Solution with an Enhanced-Solubility Enrofloxacin Crystal, and its Clinical Evaluation in Dogs.

PubMed

Miranda-Calderon, Jorge E; Gutierrez, Lilia; Ocampo, Luis; Garcia-Gutierrez, Ponciano; Tapia, Graciela; Sumano, Hector

2018-01-01

The concern about the frequent use of ciprofloxacin in veterinary medicine is linked to increased antimicrobial resistance. The corresponding fluoroquinolone for veterinary use is enrofloxacin. A new solvate form of enrofloxacin, as dihydrate-hydrochloride (enro-C) with higher water solubility than the parent compound, was formulated as an ophthalmic solution (pH 5). A multicentre, longitudinal, non-inferiority clinical study in a non-hospital environment was designed to treat 36 dogs affected by tobramycin-unresponsive conjunctivitis with either the experimental 0.5% enro-C ophthalmic preparation (enro-CG) or a commercial preparation of ciprofloxacin (cipro-G). Other causes of conjunctivitis were ruled out. Pathogens were isolated and minimum inhibitory concentration (MIC) studies of tobramycin were carried out. Three blocks of bacterial resistance were set up, beginning at the established breakpoint i.e., 4 µg/mL; 8 µg/mL and 16 µg/mL. Eighteen dogs were randomly assigned to each block. The enro-CG group was treated with two drops of the referred preparation (10 mg/eye) twice a day for 7 days, and the cipro-G group was treated with four drops of a 0.3% commercially available ciprofloxacin eye-drop preparation (9 mg/eye) twice a day, also for 7 days. Clinical and bacteriological cure rates were evaluated. Enro-C-treated dogs achieved a clinical cure one day earlier than ciprofloxacin-treated dogs, and unlike this latter group, enro-CG achieved bacteriological cure in all cases. No side effects were observed in either group, but dogs treated with enro-C showed no discomfort, allowing easier treatment-compliance. This is the first study reported on the successful formulation of enrofloxacin as an ophthalmic solution. Clinical assessment reveals outstanding clinical efficacy. It is necessary to conduct further research on clinical efficacy and toxicity, with the chronic use of this preparation under different clinical challenges. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Poly(amidoamine) dendrimers as ophthalmic vehicles for ocular delivery of pilocarpine nitrate and tropicamide.

PubMed

Vandamme, Th F; Brobeck, L

2005-01-20

The purpose of this study was to determine the influence of a controlled incremental increase in size, molecular weight and number of amine, carboxylate and hydroxyl surface groups in several series of poly(amidoamine) (PAMAM) dendrimers for controlled ocular drug delivery. The duration of residence time was evaluated after solubilization of several series of PAMAM dendrimers (generations 1.5 and 2-3.5 and 4) in buffered phosphate solutions containing 2 per thousand (w/v) of fluorescein. The New Zealand albino rabbit was used as an in vivo model for qualitative and quantitative assessment of ocular tolerance and retention time after a single application of 25 microl of dendrimer solution to the eye. The same model was also used to determine the prolonged miotic or mydriatic activities of dendrimer solutions, some containing pilocarpine nitrate and some tropicamide, respectively. Residence time was longer for the solutions containing dendrimers with carboxylic and hydroxyl surface groups. No prolongation of remanence time was observed when dendrimer concentration (0.25-2%) increased. The remanence time of PAMAM dendrimer solutions on the cornea showed size and molecular weight dependency. This study allowed novel macromolecular carriers to be designed with prolonged drug residence time for the ophthalmic route.

Topical ketorolac tromethamine 0.5% ophthalmic solution in ocular inflammation after cataract surgery.

PubMed

Solomon, K D; Cheetham, J K; DeGryse, R; Brint, S F; Rosenthal, A

2001-02-01

To compare the efficacy and safety of ketorolac 0.5% ophthalmic solution with its vehicle in the treatment of ocular inflammation after cataract surgery and intraocular lens implantation. Multicenter clinical study. One hundred four patients were prospectively randomized, 52 patients in treatment group, 52 patients in control group. Patients received either ketorolac or vehicle four times daily in the operated eye for 14 days starting the day after surgery in a prospective, double-masked, randomized, parallel group study. Only patients with moderate or greater postoperative inflammation the day after surgery were enrolled. The main outcome measures include inflammation (cell, flare, ciliary flush), intraocular pressure and visual acuity. Ketorolac was significantly more effective than vehicle in reducing the manifestations of postoperative ocular inflammation, including: anterior chamber cells (P: = 0.002) and flare (P: = 0.009), conjunctival erythema (P: = 0.010), ciliary flush (P: = 0.022), photophobia (P: = 0.027), and pain (P: = 0.043). Five times as many patients were dropped from the study for lack of efficacy from the vehicle group (22/52) than from the ketorolac group (4/52; P: = 0.001). Ketorolac was found to be equally as safe as vehicle in terms of adverse events, changes in visual acuity, intraocular pressure, and biomicroscopic and ophthalmoscopic variables. Ketorolac tromethamine 0.5% ophthalmic solution was significantly more effective than vehicle in the treatment of moderate or greater ocular inflammation following routine cataract surgery, while being as safe as vehicle.

In situ-forming hydrogels for sustained ophthalmic drug delivery.

PubMed

Nanjawade, Basavaraj K; Manvi, F V; Manjappa, A S

2007-09-26

Ophthalmic drug delivery is one of the most interesting and challenging endeavors facing the pharmaceutical scientist. The conventional ocular drug delivery systems like solutions, suspensions, and ointments show drawbacks such as increased precorneal elimination, high variability in efficiency, and blurred vision respectively. In situ-forming hydrogels are liquid upon instillation and undergo phase transition in the ocular cul-de-sac to form visco-elastic gel and this provides a response to environmental changes. In the past few years, an impressive number of novel temperature, pH, and ion induced in situ-forming systems have been reported for sustain ophthalmic drug delivery. Each system has its own advantages and drawbacks. The choice of a particular hydrogel depends on its intrinsic properties and envisaged therapeutic use. This review includes various temperature, pH, and ion induced in situ-forming polymeric systems used to achieve prolonged contact time of drugs with the cornea and increase their bioavailability.

Effect of corneal wetting solutions on corneal thickness during ophthalmic surgery.

PubMed

Emre, Sinan; Akkin, Cezmi; Afrashi, Filiz; Yağci, Ayşe

2002-01-01

To measure the changes in corneal thickness with wetting solutions used in ophthalmic surgery. Ege University, School of Medicine, Department of Ophthalmology, Izmir, Turkey. Thirty-one adult pigmented rabbits that weighed about 2.5 kg each were anesthetized with pentobarbital sodium. The rabbits were randomly divided into 3 groups to receive 3 wetting solutions: Group 1, Ringer's lactate; Group 2, balanced salt solution (BSS); and Group 3, BSS with glutation (BSS Plus). The solutions were dropped on the right cornea of the rabbits at a rate of 6.0 cc in 12 minutes using an intravenous infusion pump. Corneal thickness was measured by ultrasonic pachymetry before and after the procedure, and the between-group changes in corneal thickness were compared. The corneal thickness before and after the procedure was 361.27 microm +/- 19.3 (SD) and 380.00 +/- 25.0 microm, respectively, in Group 1 (P =.000); 372.10 +/- 18.8 microm and 388.60 +/- 24.1 microm, respectively, in Group 2 (P =.003); and 358.10 +/- 26.5 microm and 360.10 +/- 24.1 microm, respectively, in Group 3 (P =.316). As a corneal wetting solution, BSS Plus resulted in significantly fewer changes in corneal thickness than Ringer's lactate or BSS. This should be considered in cases involving long intraocular surgery.

Dendritiform Keratopathy Associated with Exposure to Polyquarternium-1, a Common Ophthalmic Preservative.

PubMed

Matoba, Alice Y; Peterson, Jeff R; Wilhelmus, Kirk R

2016-03-01

To describe dendritiform keratopathy associated with exposure to polyquaternium-1, a common preservative found in contact lens solutions and tear replacement products. Case series. Sixteen patients who demonstrated dendritiform keratopathy during topical ophthalmic exposure to polyquaternium-1. Records were reviewed of all patients diagnosed with dendritiform keratopathy between 1999 and 2014 who had documented exposure to contact lens care disinfecting solutions or artificial tear solutions containing polyquaternium-1. Patients were excluded who had coexisting potential causes for dendritiform keratopathy, such as prior herpes simplex keratitis, varicella-zoster viral keratitis, the linear form of Thygeson's superficial keratitis, epithelial regeneration line, Acanthamoeba keratitis, mucus plaque keratopathy, medication-related keratopathy, or limbal stem cell deficiency characterized by conjunctivalization of the corneal epithelium. Effect of discontinuation of exposure to polyquaternium-1 on the dendritiform keratopathy. Sixteen patients demonstrated dendritiform keratopathy after exposure to the preservative polyquaternium-1. Thirteen patients had a history of recent exposure to contact lens disinfecting solutions (Opti-Free, Equate) containing polyquaternium-1. Three patients used a tear replacement product (Systane) containing a polyquaternium-1 preservative. Four patients were treated with antiviral medications for presumed herpes simplex keratitis; 4 patients underwent diagnostic testing for Acanthamoeba keratitis. Two additional patients were diagnosed sequentially with herpes simplex keratitis, then Acanthamoeba keratitis before referral. All dendritiform lesions resolved within 2 to 6 weeks after elimination of exposure to polyquaternium-1. Ophthalmic products containing polyquaternium-1 may cause dendritiform keratopathy that may be confused with infections of the superficial cornea, such as herpes simplex virus keratitis or Acanthamoeba keratitis. Copyright © 2016 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Evaluating the efficacy of epinastine ophthalmic solution using a conjunctivitis allergen challenge model in patients with birch pollen allergic conjunctivitis.

PubMed

Tagawa, Yoshiaki; Namba, Kenichi; Nakazono, Yumi; Iwata, Daiju; Ishida, Susumu

2017-04-01

The efficacy of epinastine 0.05% ophthalmic solution for pollen allergic conjunctivitis has already been shown in a conjunctival allergen challenge (CAC) test using cedar pollen as a challenge. The present study investigated the efficacy of this solution against birch pollen conjunctivitis in a CAC test. Ten adult subjects (eight males and two females) with asymptomatic birch pollen conjunctivitis were enrolled in this study. The average age of the subjects was 41.1 years. This study was conducted during a period without birch pollen dispersion. In each subject, the epinastine 0.05% ophthalmic solution was instilled in one eye, and an artificial tear fluid was instilled in the fellow eye in a double-blind manner. Five minutes or 4 h after the drug instillation, both eyes were challenged with an optimal concentration of birch pollen, and ocular itching and conjunctival hyperemia were then graded. Tears were collected before the drug instillation and 20 min after the pollen challenge, and the histamine level was measured. The ocular itching scores and palpebral conjunctival hyperemia scores of the epinastine-treated eyes were significantly lower than those of the contralateral control eyes when the eyes were pretreated with the drug 4 h before the CAC. There was a significant correlation between the tear histamine level and mean ocular itching score of three time points (3, 5 and 10 min) following the CAC in the control eyes but not the epinastine-treated eyes. Epinastine is effective in suppressing ocular itching and conjunctival hyperemia in birch pollen conjunctivitis. Copyright © 2017 Japanese Society of Allergology. Production and hosting by Elsevier B.V. All rights reserved.

Intravenous Hyaluronidase with Urokinase as Treatment for Rabbit Retinal Artery Hyaluronic Acid Embolism.

PubMed

Chiang, ChengAn; Zhou, ShuangBai; Chen, ChuHsin; Ho, Dave S; Zhang, HuiZhong; Liu, Kai

2016-12-01

Although various salvage methods have been proposed to treat intraretinal artery hyaluronic acid embolism, their applications are still limited by various factors. The authors investigated the effectiveness of intravenous hyaluronidase with urokinase for resolving retinal artery hyaluronic acid embolism. The anatomy of rabbit ophthalmic and fundus arteries (retinal and choroid artery) was studied. Approximately 0.35 ml of hyaluronic acid was injected into the ophthalmic artery to create a retinal artery embolism model. The rabbits were grouped randomly (groups A, B, C, D, E, and F) and given hyaluronidase with urokinase intravenously at different postobstruction time points (10, 20, 30, 40, 50, and 60 minutes). Saline was given to the control group. Fundus vascular (retinal and choroid artery) reperfusion status and the effectiveness of the solution on the obstruction of each group were observed for 5 days. The animal model closely imitated actual hyaluronic acid ophthalmic/retinal artery obstructions. Three vascular conditions were observed after hyaluronidase with urokinase injection: total, partial, and no reperfusion. Groups A, B, and C showed a significantly higher overall solution effectiveness rate (total/partial reperfusion) compared with the control group (p = 0.001, p = 0.001, and p = 0.005, respectively). Solution effectiveness in groups D, E, and F showed no difference compared with the control group (p = 0.628, p = 1.000, and p = 1.000, respectively). The effectiveness of the solution drops dramatically if given after 30 minutes of obstruction. The authors' method can indeed help resolve retinal artery hyaluronic acid obstruction. Intravenous hyaluronidase with urokinase technique shows possible potential to become a standardized treatment protocol for intraretinal artery hyaluronic acid embolism with further clinical tests.

Timolol Ophthalmic

MedlinePlus

... after you instill timolol eye drops or gel-forming solution.tell your doctor if you have or have ever had thyroid, heart, or lung disease; congestive heart failure; myasthenia gravis; or diabetes.tell your doctor if you are pregnant, plan ...

Pharmaceutical Approval Update.

PubMed

Kaufman, Michele B

2018-01-01

Latanoprostene bunod ophthalmic solution (Vyzulta) for the reduction of intraocular pressure; letermovir (Prevymis) for prophylaxis of cytomegalovirus infection and disease after stem cell transplant; benralizumab (Fasenra) for the add-on maintenance treatment of severe asthma of an eosinophilic phenotype.

Short-term effect of topical antiglaucoma medication on tear-film stability, tear secretion, and corneal sensitivity in healthy subjects.

PubMed

Terai, Naim; Müller-Holz, Matthias; Spoerl, Eberhard; Pillunat, Lutz E

2011-01-01

The purpose of this study was to investigate the short-term effect of topical antiglaucoma medication on tear-film stability, tear secretion, and corneal sensitivity in healthy subjects. In this prospective, double-blind crossover trial, break-up time and basal secretion (Jones test) were measured 60 minutes before, and 30, 60, and 90 minutes after topical antiglaucoma drop application in 30 healthy subjects. Corneal sensitivity was measured 60 minutes before, and five, 10, and 15 minutes after drop application using a Cochet-Bonnet esthesiometer. Reduction of break-up time in the latanoprost group was -23.8% after 30 minutes (P = 0.21), -26.7% after 60 minutes (P = 0.03) and -51.4% after 90 minutes (P ≤ 0.003), which was statistically significant. Reduction of break-up time in all other treatment groups was not statistically significant. The Jones test revealed a significant reduction of basal secretion after application of brimonidine (-17.8%, P = 0.002; -22.5%, P < 0.001; -30.5%, P < 0.001), followed by apraclonidine (-10%, P = 0.06; -20.1%, P = 0.02; -22.1%, P = 0.002), latanoprost (-2.4%, P = 0.64; -18.6%, P = 0.001; -20.1%, P = 0.001) and dorzolamide (-0.5%, P = 0.9; 14.3%, P = 0.018; -17.3%, P = 0.004) at 30, 60, and 90 minutes after drop application. Reduction of basal secretion in all other treatment groups was not statistically significant. Latanoprost showed the most statistically significant reduction in break-up time, and brimonidine showed the most significant reduction in basal secretion of all the glaucoma medications used in this study. In conclusion, our data may be helpful for treatment decisions in glaucoma patients who also suffer from ocular surface problems.

Effect of Cromakalim Prodrug 1 (CKLP1) on Aqueous Humor Dynamics and Feasibility of Combination Therapy With Existing Ocular Hypotensive Agents

PubMed Central

Roy Chowdhury, Uttio; Rinkoski, Tommy A.; Bahler, Cindy K.; Millar, J. Cameron; Bertrand, Jacques A.; Holman, Bradley H.; Sherwood, Joseph M.; Overby, Darryl R.; Stoltz, Kristen L.; Dosa, Peter I.; Fautsch, Michael P.

2017-01-01

Purpose Cromakalim prodrug 1 (CKLP1) is a water-soluble ATP-sensitive potassium channel opener that has shown ocular hypotensive properties in ex vivo and in vivo experimental models. To determine its mechanism of action, we assessed the effect of CKLP1 on aqueous humor dynamics and in combination therapy with existing ocular hypotensive agents. Methods Outflow facility was assessed in C57BL/6 mice by ex vivo eye perfusions and by in vivo constant flow infusion following CKLP1 treatment. Human anterior segments with no trabecular meshwork were evaluated for effect on pressure following CKLP1 treatment. CKLP1 alone and in combination with latanoprost, timolol, and Rho kinase inhibitor Y27632 were evaluated for effect on intraocular pressure in C57BL/6 mice and Dutch-belted pigmented rabbits. Results CKLP1 lowered episcleral venous pressure (control: 8.9 ± 0.1 mm Hg versus treated: 6.2 ± 0.1 mm Hg, P < 0.0001) but had no detectable effect on outflow facility, aqueous humor flow rate, or uveoscleral outflow. Treatment with CKLP1 in human anterior segments without the trabecular meshwork resulted in a 50% ± 9% decrease in pressure, suggesting an effect on the distal portion of the conventional outflow pathway. CKLP1 worked additively with latanoprost, timolol, and Y27632 to lower IOP, presumably owing to combined effects on different aspects of aqueous humor dynamics. Conclusions CKLP1 lowered intraocular pressure by reducing episcleral venous pressure and lowering distal outflow resistance in the conventional outflow pathway. Owing to this unique mechanism of action, CKLP1 works in an additive manner to lower intraocular pressure with latanoprost, timolol, and Rho kinase inhibitor Y27632. PMID:29114841

Bimatoprost in the treatment of eyelash hypotrichosis

PubMed Central

Law, Simon K

2010-01-01

Eyelashes hypotrichosis is a condition indicated by an inadequate amount of eyelashes. Hypertrichosis of eyelashes, characterized by excessive eyelash growth, is a regular phenomenon associated with ophthalmic prostaglandin and prostamide analogs. Recently, the US Food and Drug Administration approved Latisse® (bimatoprost 0.03% solution), identical to the ophthalmic solution for glaucoma treatment, for increasing eyelash length, thickness and darkness in patients with hypotrichosis of the eyelashes. When prostaglandin and prostamide analogs interact with the prostanoid receptors in the hair follicle, this most likely stimulates the resting follicles (telogen phase) to growing follicles (anagen phase). Prostaglandin and prostamide analogs may also prolong the anagen phase of eyelashes, leading to an increase of eyelash length. Although bimatoprost is effective in promoting increased growth of healthy eyelashes and adnexal hairs, its effectiveness in patients with eyelash alopecia areata is debatable and its protective effect is not yet studied in patients with eyelash loss secondary to radiation or chemotherapy. Bimatoprost is generally safe when applied to the base of the eyelashes at the lid margin with minimum side effects. However, other ocular or systemic side effects associated with ophthalmic prostaglandin and prostamide analogs may occur when instilled on the surface of the eye, and patients must be informed and monitored. PMID:20463804

Acceptability, Usability, and Views on Deployment of Peek, a Mobile Phone mHealth Intervention for Eye Care in Kenya: Qualitative Study.

PubMed

Lodhia, Vaishali; Karanja, Sarah; Lees, Shelley; Bastawrous, Andrew

2016-05-09

The Portable Eye Examination Kit (Peek) is a mobile phone-based ophthalmic testing system that has been developed to perform comprehensive eye examinations. Shortages in ophthalmic personnel, the high cost, and the difficulty in transporting equipment have made it challenging to offer services, particularly in rural areas. Peek offers a solution for overcoming barriers of limited access to traditional ophthalmic testing methods and has been pilot tested on adults in Nakuru, Kenya, and compared with traditional eye examination tools. This qualitative study evaluated the acceptability and usability of Peek in addition to perceptions regarding its adoption and nationwide deployment. Semistructured interviews were conducted with patients and analyzed using a framework approach. This included analysis of interviews from 20 patients, 8 health care providers (HCPs), and 4 key decision makers in ophthalmic health care provision in Kenya. The participants were purposefully sampled. The coding structure involved predefined themes for assessing the following: (1) the context, that is, environment, user, task, and technology; (2) patient acceptability, that is, patients' perceived benefits, patient preference, and patient satisfaction; (3) usability, that is, efficiency, effectiveness, learnability, and flexibility and operability of Peek; and (4) the benefits of Peek in strengthening eye care provision, that is, capabilities enhancer, opportunity creator, social enabler, and knowledge generator. Emerging themes relating to the objectives were explored from the data using thematic analysis. Patients found Peek to be acceptable because of its benefits in overcoming the barriers to accessing ophthalmic services. Most thought it to be fast, convenient, and able to reach a large population. All patients expressed being satisfied with Peek. The HCPs perceived it to satisfy the criteria for usability and found Peek to be acceptable based on the technology acceptance model. Peek was also found to have features required for strengthening ophthalmic delivery by aiding detection and diagnosis, provision of decision support, improving communication between provider and patient and among providers, linking patients to services, monitoring, and assisting in education and training. Some of the deployment-related issues included the need for government and community involvement, communication and awareness creation, data protection, infrastructure development including capacity creation, and training and maintenance support. According to all parties interviewed, Peek is an acceptable solution, as it provides a beneficial service, supports patients' needs, and fulfills HCPs' roles, overall contributing to strengthening eye health.

Ophthalmic Drug Delivery Systems for Antibiotherapy—A Review

PubMed Central

Dubald, Marion; Bourgeois, Sandrine; Andrieu, Véronique; Fessi, Hatem

2018-01-01

The last fifty years, ophthalmic drug delivery research has made much progress, challenging scientists about the advantages and limitations of this drug delivery approach. Topical eye drops are the most commonly used formulation in ocular drug delivery. Despite the good tolerance for patients, this topical administration is only focus on the anterior ocular diseases and had a high precorneal loss of drugs due to the tears production and ocular barriers. Antibiotics are popularly used in solution or in ointment for the ophthalmic route. However, their local bioavailability needs to be improved in order to decrease the frequency of administrations and the side effects and to increase their therapeutic efficiency. For this purpose, sustained release forms for ophthalmic delivery of antibiotics were developed. This review briefly describes the ocular administration with the ocular barriers and the currently topical forms. It focuses on experimental results to bypass the limitations of ocular antibiotic delivery with new ocular technology as colloidal and in situ gelling systems or with the improvement of existing forms as implants and contact lenses. Nanotechnology is presently a promising drug delivery way to provide protection of antibiotics and improve pathway through ocular barriers and deliver drugs to specific target sites. PMID:29342879

Efficacy and safety of travoprost alone or in combination with other agents for glaucoma and ocular hypertension: patient considerations

PubMed Central

Suzuki, Emilio Rintaro; Suzuki, Cibele Lima Belico

2010-01-01

Travoprost is a prostaglandin analog used in the management of glaucoma and ocular hypertension for reducing intraocular pressure (IOP). The IOP-lowering efficacy of travoprost has been shown to be similar to that of other prostaglandins, including latanoprost and bimatoprost. When compared with fixed combinations of timolol and either latanoprost or dorzolamide, travoprost alone can reduce mean IOP in a similar or superior manner. Concomitant therapy of travoprost and timolol can reach even greater IOP reductions than fixed combinations at some time points, but with no difference in the early morning, when IOP is usually higher. In addition, the long duration of action of travoprost can also provide better control of IOP fluctuation, probably due to its stronger prostaglandin F receptor mechanism. The side effects of travoprost do not represent a risk to the vision or health of the patient. The proven efficacy and safety combined with convenient once-daily dosing for travoprost increases patient compliance with treatment for glaucoma. PMID:21060666

Optics education in an optometric setting

NASA Astrophysics Data System (ADS)

Putnam, Nicole M.

2017-08-01

The first year optics curriculum at the Arizona College of Optometry aims to provide students with an understanding of geometrical, physical, and visual optics principals that will be the foundation of their clinical understanding of the optics of the eye and its correction in advanced courses such as ophthalmic optics and contact lenses. Although the optics of the eye are a fantastic model to use in optics education, the clinical applications may not become apparent until later in the course of study. Successful strategies are needed to engage students and facilitate the understanding of optical principals and the growth of process skills including problem solving, analysis, and critical thinking that will help in their future as health care providers. These include the implementation of ophthalmic applications as early as possible, encouragement of group work including open office hours, and the use of video problem set solutions to supplement traditional static solutions.

Besifloxacin ophthalmic suspension, 0.6%: a novel topical fluoroquinolone for bacterial conjunctivitis.

PubMed

O'Brien, Terrence P

2012-06-01

Acute bacterial conjunctivitis, the most common cause of conjunctivitis, is responsible for approximately 1% of all primary-care consultations. Of the topical ophthalmic antibiotics used to treat acute bacterial conjunctivitis, fluoroquinolones are especially useful because they possess a broad antibacterial spectrum, are bactericidal in action, are generally well tolerated, and have been less prone to development of bacterial resistance. Besifloxacin, the latest advanced fluoroquinolone approved for treating bacterial conjunctivitis, is the first fluoroquinolone developed specifically for topical ophthalmic use. It has a C-8 chlorine substituent and is known as a chloro-fluoroquinolone. Besifloxacin possesses relatively balanced dual-targeting activity against bacterial topoisomerase IV and DNA gyrase (topoisomerse II), two essential enzymes involved in bacterial DNA replication, leading to increased potency and decreased likelihood of bacterial resistance developing to besifloxacin. Microbiological data suggest a relatively high potency and rapid bactericidal activity for besifloxacin against common ocular pathogens, including bacteria resistant to other fluoroquinolones, especially resistant staphylococcal species. Randomized, double-masked, controlled clinical studies demonstrated the clinical efficacy of besifloxacin ophthalmic suspension 0.6% administered three-times daily for 5 days to be superior to the vehicle alone and similar to moxifloxacin ophthalmic solution 0.5% for bacterial conjunctivitis. In addition, besifloxacin ophthalmic suspension 0.6% administered two-times daily for 3 days was clinically more effective than the vehicle alone for bacterial conjunctivitis. Besifloxacin has also been shown in preclinical animal studies to be potentially effective for the "off-label" treatment of infections following ocular surgery, prophylaxis of endophthalmitis, and the treatment of bacterial keratitis. Taken together, clinical and preclinical animal studies indicate that besifloxacin is an important new option for the treatment of ocular infections.

[Safety and efficacy of a new preservative-free levocabastine ophthalmic solution (Levofree®) using the conjunctival provocation test].

PubMed

Allaire, C; Siou-Mermet, R; Bassols, A

2012-09-01

To evaluate the safety and efficacy of preservative-free levocabastine 0.05 % ophthalmic solution compared to placebo (vehicle) and to preserved levocabastine 0.05 % ophthalmic suspension in the prevention of allergic conjunctivitis induced by a conjunctival provocation test. Ninety-two subjects (18-50 years) with a previous history of allergic conjunctivitis to pollen were randomised to receive either preservative-free levocabastine solution in one eye and preserved levocabastine suspension in the fellow eye (n=69), or preservative-free levocabastine in one eye and placebo in the fellow eye (n=23). One drop of each product was administered 10 minutes (visit 3) and 4 hours (visit 4) prior to the provocation test. The primary efficacy criterion was the sum of the itching and conjunctival hyperemia scores assessed at 3, 5 and 10 minutes after the provocation test. The safety evaluation included adverse events, visual acuity, intra-ocular pressure and study drug drop sensation. The efficacy of the preservative-free solution was significantly higher than that of placebo at all time points (P≤0.01) with one exception at visit 4 (3 minutes after the provocation test). It was significantly higher than that of the preserved suspension at visit 3, and equivalent at visit 4. The incidence of adverse events was lower with the preservative-free solution than with the preserved suspension. 94.2 % and 95.7 % subjects rated preservative-free levocabastine drop sensation as "good" or "very good" at visits 3 and 4 respectively, whereas these rates were 68.1 % and 63.8 % with preserved levocabastine. This difference between the two formulations was highly statistically significant (P<0.001). The efficacy of preservative-free levocabastine was superior to that of the placebo and of the preserved suspension at visit 3, at least as effective as the preserved suspension at visit 4, and better tolerated at each visit. Copyright © 2012 Elsevier Masson SAS. All rights reserved.

Improved Ocular Delivery of Nepafenac by Cyclodextrin Complexation.

PubMed

Shelley, Haley; Grant, Makenzie; Smith, Forrest T; Abarca, Eva M; Jayachandra Babu, R

2018-06-13

Nepafenac is a nonsteroidal anti-inflammatory drug (NSAID), currently only available as 0.1% ophthalmic suspension (Nevanac®). This study utilized hydroxypropyl-β-cyclodextrin (HPBCD) to increase the water solubility and trans-corneal permeation of nepafenac. The nepafenac-HPBCD complexation in the liquid and solid states were confirmed by phase solubility, differential scanning calorimetry (DSC), X-ray diffraction (XRD), Fourier transform infrared spectroscopy (FT-IR), and nuclear magnetic resonance spectroscopy (NMR) analyses. Nepafenac 0.1% ophthalmic solution was formulated using HPBCD (same pH and osmolality as that of Nevanac®) and pig eye trans-corneal permeation was studied versus Nevanac®. Furthermore, nepafenac content in cornea, sclera, iris, lens, aqueous humor, choroid, ciliary body, retina, and vitreous humor was studied in a continuous isolated pig eye perfusion model in comparison to the suspension and Nevanac®. Permeation studies using porcine corneas revealed that the solution formulation had a permeation rate 18 times higher than Nevanac®. Furthermore, the solution had 11 times higher corneal retention than Nevanac®. Drug distribution studies using porcine eyes revealed that the solution formulation enables detectable levels in various ocular tissues while the drug was undetectable by Nevanac®. The ocular solution formulation had a significantly higher drug concentration in the cornea compared to the suspension or Nevanac®.

Bacterial Contamination of Multi-dose Eye Drops at Ophthalmology Department, University of Gondar, Northwest Ethiopia.

PubMed

Tsegaw, Asegedech; Tsegaw, Asamere; Abula, Tefera; Assefa, Yared

2017-01-01

Ophthalmic solutions used for both diagnostic and therapeutic purposes were found to be contaminated with bacteria pathogens and caused serious ocular infections such as keratitis and endophthalmitis. The objective was to assess the magnitude and pattern of bacterial contamination of multi-dose ophthalmic medications and investigate the drug susceptibility pattern of the isolates in the Department of Ophthalmology at Gondar University Teaching Hospital. A total of 100 ophthalmic medications in-use by patients and eye-care workers have been taken and cultured for potential bacterial contamination in the Microbiology Department after 1 week and >1 week of use. The dropper tip and the residual eye medications were examined for contamination. The contaminating bacteria were identified using a standard procedure and drug susceptibility testing to selected antimicrobial agents was done. Eleven ophthalmic medications were contaminated by different bacterial species with a prevalence of 11%. Multi-use and longer duration of use of eye medications were associated with higher rate of contamination. The contamination level ranges from 0% for antibiotics, 20% for local anesthetics, and 40% for povidone iodine. Among bacteria identified, Staphylococcus aureus and coagulase-negative Staphylococcus species were resistant to methicillin while others were sensitive to the antibiotics tested. The prevalence of contamination was low, but methicillin-resistant Staphylococcus was a potential risk. It is recommended that the Department of Ophthalmology should design set of rules about duration of use and safe handling of ophthalmic medications by the staff and patients.

Mucoadhesive ophthalmic vehicles: evaluation of polymeric low-viscosity formulations.

PubMed

Saettone, M F; Monti, D; Torracca, M T; Chetoni, P

1994-01-01

A series of polyanionic natural or semi-synthetic polymers (polygalacturonic acid, hyaluronic acid, carboxymethylamylose, carboxymethylchitin, chondroitin sulfate, heparan sulfate and mesoglycan) were evaluated as potential mucoadhesive carriers for ophthalmic drugs. Solutions containing cyclopentolate (CY) or pilocarpine (PI) as salts (or polyanionic complexes) with the acidic polymers, all showing a low viscosity, were tested for miotic (resp. mydriatic) activity in albino rabbits. In the case of some polymeric complexes, small but significant increases of the areas under the activity vs. time curves (AUC) over reference cyclopentolate hydrochloride (CYHC1) or pilocarpine nitrate (PINO3) vehicles, and significant AUC decreases after removal of precorneal mucin by treatment with N-acetylcysteine were observed. A correlation was found between these data, considered indicative of the occurrence of a mucoadhesive interaction "in vivo", and "in vitro" viscometric data expressing the polymers-mucin force of interaction. The advantages and limitations of the mucoadhesive non-viscous approach in the formulation of ophthalmic vehicles are presented and discussed.

In vitro and in vivo ocular safety and eye surface permanence determination by direct and Magnetic Resonance Imaging of ion-sensitive hydrogels based on gellan gum and kappa-carrageenan.

PubMed

Fernández-Ferreiro, Anxo; González Barcia, Miguel; Gil-Martínez, María; Vieites-Prado, Alba; Lema, Isabel; Argibay, Barbara; Blanco Méndez, José; Lamas, Maria Jesus; Otero-Espinar, Francisco Javier

2015-08-01

Gellan gum, kappa-carrageenan and alginates are natural polysaccharides able to interact with different cations that can be used to elaborate ion-activated in situ gelling systems for different uses. The interaction between fluid solutions of these polysaccharides and cations presents into the tear made these biopolymers very interesting to elaborate ophthalmic drug delivery systems. The main purpose of this study is to evaluate the ability of mixtures of these polymers to obtain ion-activated ophthalmic in situ gelling systems with optimal properties for ocular use. To achieve this purpose different proportion of the biopolymers were analyzed using a mixture experimental design evaluating their transparency, mechanical properties and bioadhesion in the absence and presence of simulated tear fluid. Tear induces a rapid sol-to-gel phase transition in the mixtures forming a consistent hydrogel. The solution composed by 80% of gellan gum and 20% kappa-carrageenan showed the best mechanical and mucoadhesive properties. This mixture was evaluated for rheological behavior, microstructure, cytotoxicity, acute corneal irritancy, ex-vivo and in vivo ocular toxicity and in vivo corneal contact time using Magnetic Resonance Images (MRI) techniques. Result indicates that the system is safe at ophthalmic level and produces an extensive ocular permanence higher than 6h. Copyright © 2015 Elsevier B.V. All rights reserved.

Preparation, pharmacokinetics and pharmacodynamics of ophthalmic thermosensitive in situ hydrogel of betaxolol hydrochloride.

PubMed

Huang, Weiwei; Zhang, Nan; Hua, Haiying; Liu, Tuanbing; Tang, Yafang; Fu, Lingling; Yang, Yanan; Ma, Xiujie; Zhao, Yongxing

2016-10-01

Conventional ophthalmic formulations often eliminate rapidly after administration and cannot provide and maintain an adequate concentration of the drug in the precorneal area. To solve those problems, a thermosensitive in situ gelling and mucoadhesive ophthalmic drug delivery system was prepared and evaluated, the system was composed of poloxamer analogs and polycarbophil (PCP) and betaxolol hydrochloride (BH) was selected as model drug. The concentrations of poloxamer 407 (P407) (22% (w/v)) and poloxamer 188 (P188) (3.5% (w/v)) were identified through central composite design-response surface methodology (CCD-RSM). The BH in situ hydrogel (BH-HG) was liquid solution at low temperature and turned to semisolid at eye temperature. BH-HG showed good stability and biocompatibility, which fulfilled the requirements of ocular application. In vitro studies indicated that addition of PCP enhanced the viscosity of BH-HG and the release results of BH from BH-HG demonstrated a sustained release behavior of BH because of the gel dissolution. In vivo pharmacokinetics and pharmacodynamics studies indicated that the BH-HG formulation resulted in an improved bioavailability and a significantly lower intraocular pressure (IOP). The results suggested BH-HG could be potentially used as an in situ gelling system for ophthalmic delivery to enhance the bioavailability and efficacy. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Formulation and Stability of Solutions.

PubMed

Akers, Michael J

2016-01-01

Ready-to-use solutions are the most preferable and most common dosage forms for injectable and topical ophthalmic products. Drugs formulated as solution almost always have chemical and physical stability challenges as well as solubility limitations and the need to prevent inadvertent microbial contamination issues. The first in this series of articles took us through a discussion of optimizing the physical stability of solutions. This article concludes this series of articles with a discussion on foreign particles, protein aggregation, and immunogenicity; optimizing microbiological activity; and osmolality (tonicity) agents, and discusses how these challenges and issues are addressed.

Ultraviolet A: Visible spectral absorbance of the human cornea after transepithelial soaking with dextran-enriched and dextran-free riboflavin 0.1% ophthalmic solutions.

PubMed

Lombardo, Marco; Micali, Norberto; Villari, Valentina; Serrao, Sebastiano; Pucci, Giuseppe; Barberi, Riccardo; Lombardo, Giuseppe

2015-10-01

To evaluate the stromal concentration of 2 commercially available transepithelial riboflavin 0.1% solutions in human donor corneas with the use of spectrophotometry. University of Calabria, Rende, Italy. Experimental study. The absorbance spectra of 12 corneal tissues were measured in the 330 to 700 nm wavelength range using a purpose-designed spectrophotometry setup before and after transepithelial corneal soaking with a 15% dextran-enriched riboflavin 0.1% solution (n = 6) or a hypotonic dextran-free riboflavin 0.1% solution (n = 6). Both ophthalmic solutions contained ethylenediaminetetraacetic acid and trometamol as enhancers. In addition, 4 deepithelialized corneal tissues underwent stromal soaking with a 20% dextran-enriched riboflavin 0.1% solution and were used as controls. All the riboflavin solutions were applied topically for 30 minutes. The stromal concentration of riboflavin was quantified by analysis of absorbance spectra of the cornea collected before and after application of each solution. The mean stromal riboflavin concentration was 0.012% ± 0.003% (SD), 0.0005% ± 0.0003% (P < .001), and 0.004% ± 0.001% (P < .01) in tissues soaked with 20% dextran-enriched, 15% dextran-enriched, and hypotonic dextran-free solutions, respectively. The difference of stromal riboflavin concentration between the 2 transepithelial solutions was statistically significant (P < .01). Dextran-enriched solutions required complete corneal deepithelialization to permit effective stromal soaking with riboflavin. Nevertheless, riboflavin in hypotonic dextran-free solution with enhancers permeates across stroma through an intact epithelium. No author has a financial or proprietary interest in any material or method mentioned. Copyright © 2015 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

Comparison of preservative-free ketotifen fumarate and preserved olopatadine hydrochloride eye drops in the treatment of moderate to severe seasonal allergic conjunctivitis.

PubMed

Mortemousque, B; Bourcier, T; Khairallah, M; Messaoud, R; Brignole-Baudouin, F; Renault, D; Rebika, H; Brémond-Gignac, D

2014-01-01

To compare preservative-free ketotifen 0.025% ophthalmic solution to olopatadine 0.1% ophthalmic solution in with the treatment of seasonal allergic conjunctivitis (SAC) in clinical practice. This was a comparative, randomised, investigator-masked, pilot clinical study in adult patients with documented history of SAC and presenting with moderate to severe itching and conjunctival hyperemia. Eligible patients initiated either ketotifen or olopatadine treatment at a dose of one drop twice daily for 28days. The resolution of ocular signs and symptoms was assessed on day 7 and day 28. Itching was also assessed within 15minutes following the first instillation (day 0). Conjunctival impression cytology was performed at each visit to assess the evolution of ICAM-1 expression (day 0, 7 and 28). Seventy-five patients were randomised (ketotifen: 38 patients; olopatadine: 37 patients). At day 28, the composite score for primary criteria (itching, tearing, and conjunctival hyperemia) improved from 6.8±1.2 to 0.9±1.0 in the Ketotifen group, without statistically significant difference between treatment groups (P=0.67). There was no relevant difference between treatment groups in other efficacy parameters, except a trend for a more rapid resolution of conjunctival hyperemia in the Ketotifen group. Both drugs were well tolerated, with a trend for a better tolerability reported by patients on ketotifen compared to those on olopatadine at day 7 (P=0.054). A rapid and comparable improvement in SAC was achieved after 28days of treatment with both preservative-free ketotifen and preserved olopatadine ophthalmic solutions, with a slightly better ocular tolerance with unpreserved ketotifen 0.025% eye drops. Copyright © 2013. Published by Elsevier Masson SAS.

Alcaftadine Ophthalmic

MedlinePlus

... if your eye(s) is/are red. If your eyes are not red and you wear contact lenses, you should know that alcaftadine solution contains benzalkonium chloride, which can be absorbed by soft contact lenses. Remove your contact lenses before instilling alcaftadine and put them back in 10 minutes later.

Olopatadine Ophthalmic

MedlinePlus

... if your eye(s) is/are red. If your eye is not red and you wear contact lenses, you should know that olopatadine solution contains benzalkonium chloride, which can be absorbed by soft contact lenses. Remove your contact lenses before applying olopatadine and put them back in 10 minutes later.

Azelastine Ophthalmic

MedlinePlus

... if your eye(s) is/are red. If your eye is not red and you wear contact lenses, you should know that azelastine solution contains benzalkonium chloride, which can be absorbed by soft contact lenses. Remove your contact lenses before instilling azelastine and put them back in 10 minutes later.

Ketotifen Ophthalmic

MedlinePlus

... if your eye(s) is/are red. If your eyes are not red and you wear contact lenses, you should know that ketotifen solution contains benzalkonium chloride, which can be absorbed by soft contact lenses. Remove your contact lenses before instilling ketotifen and put them back in 10 minutes later.

21 CFR 524.1982 - Proparacaine ophthalmic solution.

Code of Federal Regulations, 2014 CFR

2014-04-01

... is used as an anesthetic in cauterization of corneal ulcers, removal of foreign bodies and sutures from the cornea, and measurement of intraocular pressure (tonometry) when glaucoma is suspected; as an... cauterization of corneal ulcers, removal of foreign bodies and sutures from the cornea, and measurement of...

In vivo eye surface residence determination by high-resolution scintigraphy of a novel ion-sensitive hydrogel based on gellan gum and kappa-carrageenan.

PubMed

Fernández-Ferreiro, Anxo; Silva-Rodríguez, Jesús; Otero-Espinar, Francisco Javier; González-Barcia, Miguel; Lamas, María Jesús; Ruibal, Alvaro; Luaces-Rodríguez, Andrea; Vieites-Prado, Alba; Lema, Isabel; Herranz, Michel; Gómez-Lado, Noemí; Blanco-Mendez, José; Gil-Martínez, María; Pardo, María; Moscoso, Alexis; Cortes, Julia; Sánchez-Martínez, María; Pardo-Montero, Juan; Aguiar, Pablo

2017-05-01

In last years, sensitive hydrogels have become a breakthrough in ophthalmic pharmaceutical technology aimed at developing new strategies to increase the residence time of active substances. In a previous paper, we qualitatively demonstrated the capacity of a new ion sensitive hydrogel to increase the residence time. Nevertheless, the clearance of the gel from the ocular surface was not quantifiable with the used methodology. The aim of the present work was to use a well-established approach based on scintigraphy to quantitatively estimate the residence time of the previously proposed hydrogel. The rat corneal residence time of a topic ophthalmic formulation containing gellan gum and kappa carragenan (0.82% w/v) labeled with 99m Tc-DTPA radiotracer was evaluated and compared with the residence of an aqueous solution. Ophthalmic safety studies such as eye irritation or passage through the cornea were also carried out. After 1.5h of contact, 77% of the hydrogel remained in the ocular surface, presenting kinetics of disappearance one-phase decay and a half time of 262min. We conclude that the novel ophthalmic hydrogel developed with kappa carrageenan and gellan gum remains for long periods of time on the corneal surface, presenting a drop that fits an exponential decay. Copyright © 2017 Elsevier B.V. All rights reserved.

Mobility experiments with microrobots for minimally invasive intraocular surgery.

PubMed

Ullrich, Franziska; Bergeles, Christos; Pokki, Juho; Ergeneman, Olgac; Erni, Sandro; Chatzipirpiridis, George; Pané, Salvador; Framme, Carsten; Nelson, Bradley J

2013-04-23

To investigate microrobots as an assistive tool for minimally invasive intraocular surgery and to demonstrate mobility and controllability inside the living rabbit eye. A system for wireless magnetic control of untethered microrobots was developed. Mobility and controllability of a microrobot are examined in different media, specifically vitreous, balanced salt solution (BSS), and silicone oil. This is demonstrated through ex vivo and in vivo animal experiments. The developed electromagnetic system enables precise control of magnetic microrobots over a workspace that covers the posterior eye segment. The system allows for rotation and translation of the microrobot in different media (vitreous, BSS, silicone oil) inside the eye. Intravitreal introduction of untethered mobile microrobots can enable sutureless and precise ophthalmic procedures. Ex vivo and in vivo experiments demonstrate that microrobots can be manipulated inside the eye. Potential applications are targeted drug delivery for maculopathies such as AMD, intravenous deployment of anticoagulation agents for retinal vein occlusion (RVO), and mechanical applications, such as manipulation of epiretinal membrane peeling (ERM). The technology has the potential to reduce the invasiveness of ophthalmic surgery and assist in the treatment of a variety of ophthalmic diseases.

76 FR 81806 - Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Topical Solution

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-29

... effectiveness against various species of external and internal parasites when cattle are treated with a topical... control infestations of certain species of external and internal parasites. The supplemental ANADA adds claims for persistent effectiveness against various species of external and internal parasites that were...

21 CFR 524.916 - Fentanyl.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Fentanyl. 524.916 Section 524.916 Food and Drugs..., AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS § 524.916 Fentanyl. (a) Specifications. Each milliliter of solution contains 50 milligrams (mg) fentanyl. (b) Sponsor. See No. 000986 in...

21 CFR 524.916 - Fentanyl.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Fentanyl. 524.916 Section 524.916 Food and Drugs..., AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS § 524.916 Fentanyl. (a) Specifications. Each milliliter of solution contains 50 milligrams (mg) fentanyl. (b) Sponsor. See No. 050929 in...

21 CFR 524.960 - Flumethasone, neomycin, and polymyxin B ophthalmic solution.

Code of Federal Regulations, 2014 CFR

2014-04-01

... use—(1) Amount—(i) Preparation containing hydroxypropyl methylcellulose. Dogs: 1 to 2 drops per eye, every 6 hours. (ii) Preparation without hydroxyproply methylcellulose. Dogs and cats: 2 to 3 drops per eye, every 4 hours. (2) Indications for use. Treatment of the inflammation, edema, and secondary...

21 CFR 886.4230 - Ophthalmic knife test drum.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic knife test drum. 886.4230 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4230 Ophthalmic knife test drum. (a) Identification. An ophthalmic knife test drum is a device intended to test the keenness of ophthalmic surgical...

21 CFR 524.960 - Flumethasone, neomycin sulfate, and polymyxin B sulfate ophthalmic solutions.

Code of Federal Regulations, 2010 CFR

2010-04-01

.... Dogs: 1 to 2 drops per eye, every 6 hours. (ii) Preparation without hydroxyproply methylcellulose. Dogs and cats: 2 to 3 drops per eye, every 4 hours. (2) Indications for use. Treatment of the inflammation, edema, and secondary bacterial infections associated with topical ophthalmological conditions of the eye...

21 CFR 524.960 - Flumethasone, neomycin sulfate, and polymyxin B sulfate ophthalmic solutions.

Code of Federal Regulations, 2011 CFR

2011-04-01

.... Dogs: 1 to 2 drops per eye, every 6 hours. (ii) Preparation without hydroxyproply methylcellulose. Dogs and cats: 2 to 3 drops per eye, every 4 hours. (2) Indications for use. Treatment of the inflammation, edema, and secondary bacterial infections associated with topical ophthalmological conditions of the eye...

21 CFR 524.463 - Copper naphthenate.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Copper naphthenate. 524.463 Section 524.463 Food... DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS § 524.463 Copper naphthenate. (a) Amount. The drug is a 37.5 percent solution of copper naphthenate. (b) Sponsors. See Nos...

21 CFR 524.463 - Copper naphthenate.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Copper naphthenate. 524.463 Section 524.463 Food... DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS § 524.463 Copper naphthenate. (a) Amount. The drug is a 37.5 percent solution of copper naphthenate. (b) Sponsors. See Nos...

75 FR 26647 - Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Topical Solution

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-12

... FURTHER INFORMATION CONTACT: John K. Harshman, Center for Veterinary Medicine (HFV-170), Food and Drug... and redelegated to the Center for Veterinary Medicine, 21 CFR part 524 is amended as follows: PART 524...)(3) of this section. * * * * * (e) * * * (2) Indications for use--(i) It is used for the treatment...

New nanomicelle curcumin formulation for ocular delivery: improved stability, solubility, and ocular anti-inflammatory treatment.

PubMed

Li, Mengshuang; Xin, Meng; Guo, Chuanlong; Lin, Guiming; Wu, Xianggen

2017-11-01

A stable topical ophthalmic curcumin formulation with high solubility, stability, and efficacy is needed for pharmaceutical use in clinics. The objective of this article was to describe a novel curcumin containing a nanomicelle formulation using a polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol (PVCL-PVA-PEG) graft copolymer. Nanomicelle curcumin was formulated and optimized and then further evaluated for in vitro cytotoxicity/in vivo ocular irritation, in vitro cellular uptake/in vivo corneal permeation, and in vitro antioxidant activity/in vivo anti-inflammatory efficacy. The solubility, chemical stability, and antioxidant activity were greatly improved after the encapsulation of the PVCL-PVA-PEG nanomicelles. The nanomicelle curcumin ophthalmic solution was simple to prepare and the nanomicelles are stable to the storage conditions, and it had good cellular tolerance. Nanomicelle curcumin also had excellent ocular tolerance in rabbits. The use of nanomicelles significantly improved in vitro cellular uptake and in vivo corneal permeation as well as improved anti-inflammatory efficacy when compared with a free curcumin solution. These findings indicate that nanomicelles could be promising topical delivery systems for the ocular administration of curcumin.

Ocular perfusion pressure and color Doppler imaging of the external ophthalmic artery of rabbits treated with sildenafil citrate.

PubMed

Costa, Ana Paula Araujo; Lima, Aline Maria Vasconcelos; da Silva, Luiz Henrique; de Oliveira Alves Carvalho, Rosângela; do Amaral, Andréia Vitor Couto; Borges, Naida Cristina

2016-07-22

It has been proposed that sildenafil citrate can increase ocular blood flow, and that this property can be used to treat ocular disorders that involve reflex vasoconstriction. This study therefore proposes to ascertain the vasodilator effect of the drug on retrobulbar circulation in healthy rabbits. For this matter rabbits treated with sildenafil citrate or saline solution had their intraocular pressure (IOP), mean arterial pressure (MAP), ocular perfusion pressure (OPP) and color Doppler imaging of the external ophthalmic artery measured prior to treatment and on days one (moment M1), seven (when M2), fourteen (moment M3), twenty-one (moment M4), and thirty (moment M5) of treatment. The MAP and OPP values of treated group were lower than those of control group at all times, and the mean values differed statistically at moments M1 (S = 71.52 mmHg, C = 84.76 mmHg, p = 0.0356) and M5 (S = 71.38 mmHg, C = 85.52 mmHg, p = 0.0252). The IOP and color Doppler values of the external ophthalmic artery did not differ between tested groups. The dose of 10 mg of sildenafil citrate administered to healthy rabbits causes systemic vasodilation and consequently lower values of MAP and OPP. However, it does not induce changes in IOP and retrobulbar hemodynamics identifiable by color Doppler assessment of the external ophthalmic artery.

Basics of Compounding: Compounding Irrigation Solutions for Sterile and Nonsterile Preparations.

PubMed

Allen, Loyd V

2017-01-01

Compounding pharmacists are sometimes called upon to prepare irrigation solutions, especially in the hospital or clinical setting. Irrigations are indicated for washing or bathing surgical incisions, wounds, and body tissues, including body cavities. Some irrigation solutions coming in contact with exposed tissue, must meet stringent requirements of sterility and bacterial endotoxins. Compounded irrigation solutions may involve wound(s), the bladder, and also may be for ophthalmic, otic, and nasal application. Some vaginal douches/instillations and rectal solutions may also be used as irrigations. As with any medication administered to the body or used on body tissues, there are requirements, and these may vary depending on the type of irrigation solution involved. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

The hen's egg chorioallantoic membrane (HET-CAM) test to predict the ophthalmic irritation potential of a cysteamine-containing gel: Quantification using Photoshop® and ImageJ.

PubMed

McKenzie, Barbara; Kay, Graeme; Matthews, Kerr H; Knott, Rachel M; Cairns, Donald

2015-07-25

A modified hen's egg chorioallantoic membrane (HET-CAM) test has been developed, combining ImageJ analysis with Adobe(®) Photoshop(®). The irritation potential of an ophthalmic medicine can be quantified using this method, by monitoring damage to blood vessels. The evaluation of cysteamine containing hyaluronate gel is reported. The results demonstrated that the novel gel formulation is non-irritant to the ocular tissues, in line with saline solution (negative control). In conclusion, the modification of the established HET-CAM test can quantify the damage to minute blood vessels. These results offer the possibility to formulate cysteamine in an ocular applicable gel formulation. Copyright © 2015 Elsevier B.V. All rights reserved.

Fast and robust estimation of ophthalmic wavefront aberrations

NASA Astrophysics Data System (ADS)

Dillon, Keith

2016-12-01

Rapidly rising levels of myopia, particularly in the developing world, have led to an increased need for inexpensive and automated approaches to optometry. A simple and robust technique is provided for estimating major ophthalmic aberrations using a gradient-based wavefront sensor. The approach is based on the use of numerical calculations to produce diverse combinations of phase components, followed by Fourier transforms to calculate the coefficients. The approach does not utilize phase unwrapping nor iterative solution of inverse problems. This makes the method very fast and tolerant to image artifacts, which do not need to be detected and masked or interpolated as is needed in other techniques. These features make it a promising algorithm on which to base low-cost devices for applications that may have limited access to expert maintenance and operation.

The Effects of Netarsudil Ophthalmic Solution on Aqueous Humor Dynamics in a Randomized Study in Humans.

PubMed

Kazemi, Arash; McLaren, Jay W; Kopczynski, Casey C; Heah, Theresa G; Novack, Gary D; Sit, Arthur J

2018-06-01

Netarsudil, an inhibitor of Rho kinase and a norepinephrine transporter, has been shown to lower elevated intraocular pressure (IOP) in controlled studies of patients with open-angle glaucoma and ocular hypertension, and in healthy volunteers. The mechanism of this ocular hypotensive effect in humans is unknown. The objective of this study was to evaluate the effect of netarsudil 0.02% on aqueous humor dynamics (AHD) parameters. In this double-masked, vehicle-controlled, paired-eye comparison study, 11 healthy volunteers received topical netarsudil ophthalmic solution 0.02% or its vehicle once daily for 7 days (morning dosing). The primary endpoints were the change in AHD parameters, compared between active and vehicle-treated eyes. In netarsudil-treated eyes, diurnal outflow facility increased from 0.27 ± 0.10 μL/min/mmHg to 0.33 ± 0.11 μL/min/mmHg (+22%; P = 0.02) after 7 days of treatment. In placebo-treated eyes, diurnal outflow facility did not significantly change (P = 0.94). The difference between netarsudil and placebo eyes in diurnal change of outflow facility was 0.08 μL/min/mmHg (P < 0.001). Diurnal episcleral venous pressure (EVP) in netarsudil-treated eyes decreased from 7.9 ± 1.2 mmHg to 7.2 ± 1.8 (-10%; P = 0.01). Diurnal EVP was not significantly different between netarsudil- and placebo-treated eyes. There was a trend toward decreasing aqueous humor flow rate (-15%; P = 0.08). No treatment changes were seen in uveoscleral outflow rate. Once-daily dosing of netarsudil ophthalmic solution 0.02% lowered IOP through increasing trabecular outflow facility and reducing EVP. This suggests a combination of mechanisms that affect both the proximal and distal outflow pathways.

Antioxidant content and ultraviolet absorption characteristics of human tears.

PubMed

Choy, Camus Kar Man; Cho, Pauline; Benzie, Iris F F

2011-04-01

Dry eye syndrome is a common age-related disorder, and decreased antioxidant/ultraviolet (UV) radiation protection in tears may be part of the cause. This study aimed to compare the tear antioxidant content and flow rate in young and older adults. The total antioxidant content and UV absorbing properties of various commercially available ophthalmic solutions used to alleviate dry eye symptoms were also examined. Minimally stimulated tears were collected from 120 healthy Chinese adults with no ocular pathology. Two age groups were studied: 19 to 29 years (n = 58) and 50 to 75 years (n = 62). Tear samples from each subject and 13 ophthalmic solutions were analyzed for total antioxidant content (as the Ferric Reducing/Antioxidant Power value). Tear flow rates were estimated from time taken to collect a fixed volume of tear fluid. UV absorbance spectra of pooled fresh reflex tear fluid and the ophthalmic solutions were determined. Results showed that the antioxidant content of minimally stimulated tears from older subjects (398 ± 160 μmol/l) was not significantly lower than that of younger subjects (348 ± 159 μmol/l; p = 0.0915). However, there was a significant difference in the tear flow rates between the two groups (p < 0.0001), with the younger group having three to four fold higher flow rate. None of the commercial preparations tested had detectable antioxidant content, and none showed the UV absorption characteristics of natural reflex tears. The effect of low flow rate on the dynamic antioxidant supply to the corneal surface indicates that older subjects have poorer overall defense against photooxidative and other oxidative processes. This could predispose older persons to corneal stress and development of dry eye syndrome. The commercially available artificial tears tested lack both the antioxidant content and UV absorbing characteristics of natural tears. Artificial tears formulations that help restore natural antioxidant and UV absorbing properties to the tear film of the aging eye may help prevent or improve dry eye symptoms and promote ocular health.

Simulated Leaching (Migration) Study for a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products.

PubMed

Jenke, Dennis; Egert, Thomas; Hendricker, Alan; Castner, James; Feinberg, Tom; Houston, Christopher; Hunt, Desmond G; Lynch, Michael; Nicholas, Kumudini; Norwood, Daniel L; Paskiet, Diane; Ruberto, Michael; Smith, Edward J; Holcomb, Frank; Markovic, Ingrid

2017-01-01

A simulating leaching (migration) study was performed on a model container-closure system relevant to parenteral and ophthalmic drug products. This container-closure system consisted of a linear low-density polyethylene bottle (primary container), a polypropylene cap and an elastomeric cap liner (closure), an adhesive label (labeling), and a foil overpouch (secondary container). The bottles were filled with simulating solvents (aqueous salt/acid mixture at pH 2.5, aqueous buffer at pH 9.5, and 1/1 v/v isopropanol/water), a label was affixed to the filled and capped bottles, the filled bottles were placed into the foil overpouch, and the filled and pouched units were stored either upright or inverted for up to 6 months at 40 °C. After storage, the leaching solutions were tested for leached substances using multiple complementary analytical techniques to address volatile, semi-volatile, and non-volatile organic and inorganic extractables as potential leachables.The leaching data generated supported several conclusions, including that (1) the extractables (leachables) profile revealed by a simulating leaching study can qualitatively be correlated with compositional information for materials of construction, (2) the chemical nature of both the extracting medium and the individual extractables (leachables) can markedly affect the resulting profile, and (3) while direct contact between a drug product and a system's material of construction may exacerbate the leaching of substances from that material by the drug product, direct contact is not a prerequisite for migration and leaching to occur. LAY ABSTRACT: The migration of container-related extractables from a model pharmaceutical container-closure system and into simulated drug product solutions was studied, focusing on circumstances relevant to parenteral and ophthalmic drug products. The model system was constructed specifically to address the migration of extractables from labels applied to the outside of the primary container. The study demonstrated that (1) the extractables that do migrate can be correlated to the composition of the materials used to construct the container-closure systems, (2) the extent of migration is affected by the chemical nature of the simulating solutions and the extractables themselves, and (3) even though labels may not be in direct contact with a contained solution, label-related extractables can accumulate as leachables in those solutions. © PDA, Inc. 2017.

Biopharmaceutical evaluation of surface active ophthalmic excipients using in vitro and ex vivo corneal models.

PubMed

Juretić, Marina; Cetina-Čižmek, Biserka; Filipović-Grčić, Jelena; Hafner, Anita; Lovrić, Jasmina; Pepić, Ivan

2018-07-30

The objective of this study was to systematically investigate the effects of surface active ophthalmic excipients on the corneal permeation of ophthalmic drugs using in vitro (HCE-T cell-based model) and ex vivo (freshly excised porcine cornea) models. The permeation of four ophthalmic drugs (i.e., timolol maleate, chloramphenicol, diclofenac sodium and dexamethasone) across in vitro and ex vivo corneal models was evaluated in the absence and presence of four commonly used surface active ophthalmic excipients (i.e., Polysorbate 80, Tyloxapol, Cremophor® EL and Pluronic® F68). The concentration and self-aggregation-dependent effects of surface active ophthalmic excipients on ophthalmic drug permeability were studied from the concentration region where only dissolved monomer molecules of surface active ophthalmic excipients exist, as well as the concentration region in which aggregates of variable size and dispersion are spontaneously formed. Neither the surface active ophthalmic excipients nor the ophthalmic drugs at all concentrations that were tested significantly affected the barrier properties of both corneal models, as assessed by transepithelial electrical resistance (TEER) monitoring during the permeability experiments. The lowest concentration of all investigated surface active ophthalmic excipients did not significantly affect the ophthalmic drug permeability across both of the corneal models that were used. For three ophthalmic drugs (i.e., chloramphenicol, diclofenac sodium and dexamethasone), depressed in vitro and ex vivo permeability were observed in the concentration range of either Polysorbate 80, Tyloxapol, Cremophor® EL or Pluronic® F68, at which self-aggregation is detected. The effect was the most pronounced for Cremophor® EL (1 and 2%, w/V) and was the least pronounced for Pluronic® F68 (1%, w/V). However, all surface active ophthalmic excipients over the entire concentration range that was tested did not significantly affect the in vitro and ex vivo permeability of timolol maleate, which is the most hydrophilic ophthalmic drug that was investigated. The results of the dynamic light scattering measurements point to the association of ophthalmic drugs with self-aggregates of surface active ophthalmic excipients as the potential mechanism of the observed permeability-depressing effect of surface active ophthalmic excipients. A strong and statistically significant correlation was observed between in vitro and ex vivo permeability of ophthalmic drugs in the presence of surface active ophthalmic excipients, which indicates that the observed permeability-altering effects of surface active ophthalmic excipients were comparable and were mediated by the same mechanism in both corneal models. Copyright © 2018 Elsevier B.V. All rights reserved.

Preoperative Hand Decontamination in Ophthalmic Surgery: A Comparison of the Removal of Bacteria from Surgeons' Hands by Routine Antimicrobial Scrub versus an Alcoholic Hand Rub.

PubMed

Forer, Yaara; Block, Colin; Frenkel, Shahar

2017-09-01

The goal of this experiment was to evaluate and compare the antimicrobial efficacy of routine preoperative hand washing using commercial medicated sponge brushes versus an alcoholic hand rub, by comparing bacterial growth on ophthalmic surgeons' hands after application of each of these methods. Twenty ophthalmic surgeons were recruited at the Hadassah-Hebrew University Medical Center in Jerusalem, Israel. Samples were collected twice from the hands of each surgeon after hand decontamination using two different protocols during routine surgical practice. The routine preparation consisted of a 3-minute surgical scrub using commercial brush-sponges incorporating either 4% chlorhexidine gluconate (CHG) or 1% povidone-iodine (PVP-I) formulations with detergent, followed by drying the hands with a sterile towel, while the 70% ethanol solution was applied for 60-seconds and allowed to air dry. Half of the group was randomly assigned to provide samples first after the routine method and the alcoholic solution a week later, and the other half of the group was sampled in the reverse order. Viable counts of bacteria were evaluated using a modified glove juice method. Bacterial colonies were enumerated after incubation for 24 hours and expressed as colony forming units (CFU)/mL for each pair of hands. Geometric mean counts were 1310 and 39 CFU/mL, in the routine and alcohol rub groups, respectively, representing a mean log 10 reduction in 1.53. The difference between the paired bacterial counts for the routine versus the alcohol rub was statistically significant (p < 0.0001). There was no statistically significant difference between log 10 reductions for CHG and PVP-I (p = 0.97). This study provides evidence that an alcohol rub protocol is more effective in reducing bacterial counts on hands than routine surgical hand preparation with PVP-I and CHG in a population of practicing ophthalmic surgeons in the operative clinical setting. Thus, it provides a safe alternative as a preoperative hand disinfection method.

21 CFR 524.1200b - Kanamycin ophthalmic aqueous solution.

Code of Federal Regulations, 2011 CFR

2011-04-01

...) of this chapter. (c) Conditions of use. It is indicated for use in dogs in various eye infections due..., removal of foreign bodies, and intraocular surgery. Instill a few drops into the affected eye every 3... least 48 hours after the eye appears normal. For use only by or on the order of a licensed veterinarian...

21 CFR 524.1200b - Kanamycin ophthalmic aqueous solution.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) of this chapter. (c) Conditions of use. It is indicated for use in dogs in various eye infections due..., removal of foreign bodies, and intraocular surgery. Instill a few drops into the affected eye every 3... least 48 hours after the eye appears normal. For use only by or on the order of a licensed veterinarian...

21 CFR 524.390b - Chloramphenicol ophthalmic solution.

Code of Federal Regulations, 2011 CFR

2011-04-01

... milligrams of chloramphenicol. (b) Sponsor. See No. 017030 in § 510.600(c) of this chapter. (c) Conditions of use. Dogs and Cats—(1) Amount. Apply one or two drops, 4 to 6 times a day for the first 72 hours...) Limitations. Therapy for cats should not exceed 7 days. As with other antibiotics, prolonged use may result in...

76 FR 71044 - Determination That TRAVATAN (Travoprost Ophthalmic Solution), 0.004%, Was Not Withdrawn From Sale...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-16

... Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and... not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to... or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of...

Diquafosol sodium ophthalmic solution for the treatment of dry eye: clinical evaluation and biochemical analysis of tear composition.

PubMed

Shigeyasu, Chika; Yamada, Masakazu; Akune, Yoko; Tsubota, Kazuo

2015-11-01

To evaluate the clinical efficacy of 3% diquafosol sodium ophthalmic solution for dry eye, and to analyze the concentration of tear proteins and mucin-like substances after the treatment. Fifty eyes of 25 patients with dry eye syndrome were prospectively enrolled. The patients were treated with diquafosol solution at a dose of 1 drop in each eye 6 times daily for 4 weeks. The parameters of clinical efficacy were tear osmolarity, tear breakup time (BUT), fluorescein staining scores for the cornea and conjunctiva, Schirmer test values, and subjective symptoms evaluated using the ocular surface disease index (OSDI). Tears collected with Schirmer test strips were analyzed by high-performance liquid chromatography, and the concentrations of the total protein and the 4 major tear proteins, namely, secretory IgA, lactoferrin, lipocalin-1, lysozyme, and N-acetyl-neuraminic acid (Neu5Ac), were measured. Neu5Ac is a major sialic acid, a marker of secretory mucins. The BUT, keratoconjunctival staining scores, and Schirmer test values were improved with statistical significance after the treatment with diquafosol solution, while changes in the other parameters, including tear osmolarity, corneal staining scores, and OSDI scores were not significant. The Neu5Ac concentration was significantly increased, which was not accompanied by changes in tear proteins. Topical application of diquafosol significantly improved the clinical parameters of the BUT, keratoconjunctival staining scores, and Schirmer test values and was accompanied by increased sialic acid content in the tears of patients with dry eye.

Application of an experimental design for the optimization and validation of a new HPLC method for the determination of vancomycin in an extemporaneous ophthalmic solution.

PubMed

Enrique, Montse; García-Montoya, Encarna; Miñarro, Montserrat; Orriols, Anna; Ticó, Joseph Ramon; Suñé-Negre, Joseph Maria; Pérez-Lozano, Pilar

2008-10-01

An experimental design has been used to develop and optimize a new high-performance liquid chromatographic (HPLC) method for the determination of Vancomycin in an extemporaneous ophthalmic solution. After the preliminary studies and literature review, the optimized method was carried out on a second generation of a C18 reverse-phase column (Luna 150 x 4.6 mm i.d., 5 microm particle size) and using methanol as organic phase, a less toxic solvent than acetonitrile, described in the extended literature. The experimental design consisted of a Placket-Burman design where six different variables were studied (flow rate, mL/min; temperature, degrees C; pH mobile phase; % buffer solution; wavelength; and injection volume) to obtain the best suitability parameters (Capacity factor-K', tailing factor, resolution, and theoretical plates). After the optimization of the chromatographic conditions and statistical treatment of the obtained results, the final method uses a mixture of a buffer solution of water-phosphoric acid (85%) (99.83:0.17, v/v) adjusted to pH 3.0 using triethylamine and mixed with methanol (87:13, v/v). The separation is achieved using a flow rate of 1.0 mL/min at 35 degrees C. The UV detector was operated at 280 nm. The validation study carried out, demonstrates the viability of the method, obtaining a good selectivity, linearity, precision, accuracy, and sensitivity.

21 CFR 886.4250 - Ophthalmic electrolysis unit.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ophthalmic electrolysis unit. 886.4250 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4250 Ophthalmic electrolysis unit. (a) Identification. An ophthalmic electrolysis unit is an AC-powered or battery-powered device intended to destroy...

21 CFR 886.4250 - Ophthalmic electrolysis unit.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic electrolysis unit. 886.4250 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4250 Ophthalmic electrolysis unit. (a) Identification. An ophthalmic electrolysis unit is an AC-powered or battery-powered device intended to destroy...

21 CFR 886.4250 - Ophthalmic electrolysis unit.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic electrolysis unit. 886.4250 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4250 Ophthalmic electrolysis unit. (a) Identification. An ophthalmic electrolysis unit is an AC-powered or battery-powered device intended to destroy...

21 CFR 886.4250 - Ophthalmic electrolysis unit.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ophthalmic electrolysis unit. 886.4250 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4250 Ophthalmic electrolysis unit. (a) Identification. An ophthalmic electrolysis unit is an AC-powered or battery-powered device intended to destroy...

21 CFR 886.4250 - Ophthalmic electrolysis unit.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic electrolysis unit. 886.4250 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4250 Ophthalmic electrolysis unit. (a) Identification. An ophthalmic electrolysis unit is an AC-powered or battery-powered device intended to destroy...

21 CFR 886.5100 - Ophthalmic beta radiation source.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic beta radiation source. 886.5100 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5100 Ophthalmic beta radiation source. (a) Identification. An ophthalmic beta radiation source is a device intended to apply superficial...

21 CFR 886.5100 - Ophthalmic beta radiation source.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ophthalmic beta radiation source. 886.5100 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5100 Ophthalmic beta radiation source. (a) Identification. An ophthalmic beta radiation source is a device intended to apply superficial...

21 CFR 886.5100 - Ophthalmic beta radiation source.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ophthalmic beta radiation source. 886.5100 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5100 Ophthalmic beta radiation source. (a) Identification. An ophthalmic beta radiation source is a device intended to apply superficial...

21 CFR 886.5100 - Ophthalmic beta radiation source.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic beta radiation source. 886.5100 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5100 Ophthalmic beta radiation source. (a) Identification. An ophthalmic beta radiation source is a device intended to apply superficial...

21 CFR 886.5100 - Ophthalmic beta radiation source.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic beta radiation source. 886.5100 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5100 Ophthalmic beta radiation source. (a) Identification. An ophthalmic beta radiation source is a device intended to apply superficial...

Ophthalmic regional blocks: management, challenges, and solutions

PubMed Central

Palte, Howard D

2015-01-01

In the past decade ophthalmic anesthesia has witnessed a major transformation. The sun has set on the landscape of ophthalmic procedures performed under general anesthesia at in-hospital settings. In its place a new dawn has ushered in the panorama of eye surgeries conducted under regional and topical anesthesia at specialty eye care centers. The impact of the burgeoning geriatric population is that an increasing number of elderly patients will present for eye surgery. In order to accommodate increased patient volumes and simultaneously satisfy administrative initiatives directed at economic frugality, administrators will seek assistance from anesthesia providers in adopting measures that enhance operating room efficiency. The performance of eye blocks in a holding suite meets many of these objectives. Unfortunately, most practicing anesthesiologists resist performing ophthalmic regional blocks because they lack formal training. In future, anesthesiologists will need to block eyes and manage common medical conditions because economic pressures will eliminate routine preoperative testing. This review addresses a variety of topical issues in ophthalmic anesthesia with special emphasis on cannula and needle-based blocks and the new-generation antithrombotic agents. In a constantly evolving arena, the sub-Tenon’s block has gained popularity while the deep angulated intraconal (retrobulbar) block has been largely superseded by the shallower extraconal (peribulbar) approach. Improvements in surgical technique have also impacted anesthetic practice. For example, phacoemulsification techniques facilitate the conduct of cataract surgery under topical anesthesia, and suture-free vitrectomy ports may cause venous air embolism during air/fluid exchange. Hyaluronidase is a useful adjuvant because it promotes local anesthetic diffusion and hastens block onset time but it is allergenic. Ultrasound-guided eye blocks afford real-time visualization of needle position and local anesthetic spread. An advantage of sonic guidance is that it may eliminate the hazard of globe perforation by identifying abnormal anatomy, such as staphyloma. PMID:26316814

21 CFR 886.4390 - Ophthalmic laser.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic laser. 886.4390 Section 886.4390 Food... DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4390 Ophthalmic laser. (a) Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin...

21 CFR 886.4390 - Ophthalmic laser.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ophthalmic laser. 886.4390 Section 886.4390 Food... DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4390 Ophthalmic laser. (a) Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin...

21 CFR 886.5800 - Ophthalmic bar reader.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic bar reader. 886.5800 Section 886.5800...) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5800 Ophthalmic bar reader. (a) Identification. An ophthalmic bar reader is a device that consists of a magnifying lens intended for use by a...

21 CFR 886.4750 - Ophthalmic eye shield.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ophthalmic eye shield. 886.4750 Section 886.4750...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4750 Ophthalmic eye shield. (a) Identification. An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended to...

21 CFR 886.4750 - Ophthalmic eye shield.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic eye shield. 886.4750 Section 886.4750...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4750 Ophthalmic eye shield. (a) Identification. An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended to...

21 CFR 886.1410 - Ophthalmic trial lens clip.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic trial lens clip. 886.1410 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1410 Ophthalmic trial lens clip. (a) Identification. An ophthalmic trial lens clip is a device intended to hold prisms, spheres, cylinders, or...

21 CFR 886.1420 - Ophthalmic lens gauge.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic lens gauge. 886.1420 Section 886.1420...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1420 Ophthalmic lens gauge. (a) Identification. An ophthalmic lens gauge is a calibrated device intended to manually measure the curvature of a...

21 CFR 886.1655 - Ophthalmic Fresnel prism.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ophthalmic Fresnel prism. 886.1655 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1655 Ophthalmic Fresnel prism. (a) Identification. An ophthalmic Fresnel prism is a device that is a thin plastic sheet with embossed rulings which...

21 CFR 886.1655 - Ophthalmic Fresnel prism.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ophthalmic Fresnel prism. 886.1655 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1655 Ophthalmic Fresnel prism. (a) Identification. An ophthalmic Fresnel prism is a device that is a thin plastic sheet with embossed rulings which...

21 CFR 886.1655 - Ophthalmic Fresnel prism.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic Fresnel prism. 886.1655 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1655 Ophthalmic Fresnel prism. (a) Identification. An ophthalmic Fresnel prism is a device that is a thin plastic sheet with embossed rulings which...

21 CFR 886.1655 - Ophthalmic Fresnel prism.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic Fresnel prism. 886.1655 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1655 Ophthalmic Fresnel prism. (a) Identification. An ophthalmic Fresnel prism is a device that is a thin plastic sheet with embossed rulings which...

21 CFR 886.1655 - Ophthalmic Fresnel prism.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic Fresnel prism. 886.1655 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1655 Ophthalmic Fresnel prism. (a) Identification. An ophthalmic Fresnel prism is a device that is a thin plastic sheet with embossed rulings which...

21 CFR 886.1670 - Ophthalmic isotope uptake probe.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic isotope uptake probe. 886.1670 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1670 Ophthalmic isotope uptake probe. (a) Identification. An ophthalmic isotope uptake probe is an AC-powered device intended to measure...

21 CFR 886.1670 - Ophthalmic isotope uptake probe.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ophthalmic isotope uptake probe. 886.1670 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1670 Ophthalmic isotope uptake probe. (a) Identification. An ophthalmic isotope uptake probe is an AC-powered device intended to measure...

21 CFR 886.1670 - Ophthalmic isotope uptake probe.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic isotope uptake probe. 886.1670 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1670 Ophthalmic isotope uptake probe. (a) Identification. An ophthalmic isotope uptake probe is an AC-powered device intended to measure...

21 CFR 886.4790 - Ophthalmic sponge.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic sponge. 886.4790 Section 886.4790 Food... DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4790 Ophthalmic sponge. (a) Identification. An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton...

21 CFR 886.4390 - Ophthalmic laser.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic laser. 886.4390 Section 886.4390 Food... DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4390 Ophthalmic laser. (a) Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin...

21 CFR 886.4390 - Ophthalmic laser.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic laser. 886.4390 Section 886.4390 Food... DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4390 Ophthalmic laser. (a) Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin...

21 CFR 886.4390 - Ophthalmic laser.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ophthalmic laser. 886.4390 Section 886.4390 Food... DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4390 Ophthalmic laser. (a) Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin...

21 CFR 886.1140 - Ophthalmic chair.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic chair. 886.1140 Section 886.1140 Food... DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1140 Ophthalmic chair. (a) Identification. An ophthalmic chair is an AC-powered or manual device with adjustable positioning in which a patient is to sit...

21 CFR 886.1405 - Ophthalmic trial lens set.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic trial lens set. 886.1405 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1405 Ophthalmic trial lens set. (a) Identification. An ophthalmic trial lens set is a device that is a set of lenses of various dioptric powers...

21 CFR 886.5810 - Ophthalmic prism reader.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ophthalmic prism reader. 886.5810 Section 886.5810...) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5810 Ophthalmic prism reader. (a) Identification. An ophthalmic prism reader is a device intended for use by a patient who is in a supine position...

21 CFR 886.5810 - Ophthalmic prism reader.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic prism reader. 886.5810 Section 886.5810...) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5810 Ophthalmic prism reader. (a) Identification. An ophthalmic prism reader is a device intended for use by a patient who is in a supine position...

21 CFR 886.5810 - Ophthalmic prism reader.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic prism reader. 886.5810 Section 886.5810...) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5810 Ophthalmic prism reader. (a) Identification. An ophthalmic prism reader is a device intended for use by a patient who is in a supine position...

21 CFR 886.5810 - Ophthalmic prism reader.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ophthalmic prism reader. 886.5810 Section 886.5810...) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5810 Ophthalmic prism reader. (a) Identification. An ophthalmic prism reader is a device intended for use by a patient who is in a supine position...

Determination of ethylene oxide, ethylene chlorohydrin, and ethylene glycol in aqueous solutions and ethylene oxide residues in associated plastics.

PubMed

Ball, N A

1984-09-01

A gas chromatographic (GC) method was developed for the determination of ethylene oxide and its two reaction products, ethylene chlorohydrin and ethylene glycol, in aqueous ophthalmic solutions. Propylene oxide was used as an internal standard. All three components were determined in one isothermal chromatographic analysis in less than 15 min. An extraction method for the determination of ethylene oxide residues in plastic components was also developed, and certain plastics with different ethylene oxide retention characteristics were identified.

Management of hypotrichosis of the eyelashes: Focus on bimatoprost

PubMed Central

Fagien, Steven

2010-01-01

Prominent eyelashes are generally recognized as enhancing beauty and are often desired by women. Until recently, the options available to augment the prominence of eyelashes were limited to makeup, over-the-counter products, artificial eyelashes, and eyelash transplantation. Originally approved for the treatment of ocular hypertension, the prostamide, bimatoprost, is now approved for the treatment of hypotrichosis of the eyelashes. Bimatoprost ophthalmic solution 0.03%, applied once daily to the skin of the upper eyelid margin using sterile single-use-per-eye applicators, increases eyelash growth, including length, thickness, and darkness. The effectiveness of bimatoprost for eyelash growth has been demonstrated by clinician ratings, digital image analysis, and patient-reported measures of satisfaction. The effects of bimatoprost treatment on eyelash length, thickness, and darkness are believed to result from longer anagen duration, increased hair bulb thickness, and increased melanogenesis, respectively. Dermally applied bimatoprost appears to be associated with a lower incidence of adverse events than administration of the medication as an eyedrop. This more favorable safety and tolerability profile is likely mediated by decreased exposure of ocular tissues to bimatoprost when applied dermally. Taken together, available data suggest that cutaneous application of bimatoprost ophthalmic solution 0.03% safely and effectively enhances upper eyelash growth. PMID:21437058

Current gamma knife treatment for ophthalmic branch of primary trigeminal neuralgia

PubMed Central

Shan, Guo-Yong; Liang, Hao-Fang; Zhang, Jian-Hua

2011-01-01

AIM To probe into problems existing in gamma knife treatment of ophthalmic branch of primary trigeminal neuralgia (TN), and propose a safe and effective solution to the problem. METHODS Through sorting the literature reporting gamma knife treatment of refractory TN in recent years, this article analyzed the advantages and problems of gamma knife treatment of primary TN, and proposed reasonable assessment for existing problems and the possible solution. RESULTS Gamma knife treatment of TN has drawn increasing attention of clinicians due to its unique non-invasion, safety and effectiveness, but there are three related issues to be considered. The first one is the uncertainty of the optimal dose (70-90GY); the second one is the difference in radiotherapy target selection (using a single isocenter or two isocenters); and the third one is the big difference of recurrent pains (specific treatment methods need to be summarized and improved). CONCLUSION For patients with refractory TN, gamma knife treatment can be selected when the medical treatment fails or drug side effects emerge. The analysis of a large number of TN patients receiving gamma knife treatment has shown that this is a safe and effective treatment method. PMID:22553625

Sustained ophthalmic delivery of highly soluble drug using pH-triggered inner layer-embedded contact lens.

PubMed

Zhu, Qiang; Cheng, Hongbo; Huo, Yingnan; Mao, Shirui

2018-06-10

In the present work the feasibility of using inner layer-embedded contact lenses (CLs) to achieve sustained release of highly water soluble drug, betaxolol hydrochloride (BH) on the ocular surface was investigated. Blend film of cellulose acetate and Eudragit S100 was selected as the inner layer, while silicone hydrogel was used as outer layer to construct inner layer-embedded contact lenses. Influence of polymer ratio in the blend film on in vitro drug release behavior in phosphate buffered solution or simulated tear fluid was studied and drug-polymer interaction, erosion and swelling of the blend film were characterized to better understand drug-release mechanism. Storage stability of the inner layer-embedded contact lenses in phosphate buffer solution was also conducted, with ignorable drug loss and negligible change in drug release pattern within 30 days. In vivo pharmacokinetic study in rabbits showed sustained drug release for over 240 h in tear fluid, indicating prolonged drug precorneal residence time. In conclusion, cellulose acetate/Eudragit S100 inner layer-embedded contact lenses are quite promising as controlled-release carrier of highly water soluble drug for ophthalmic delivery. Copyright © 2018 Elsevier B.V. All rights reserved.

Utility of Experimental Design in Pre-Column Derivatization for the Analysis of Tobramycin by HPLC-Fluorescence Detection: Application to Ophthalmic Solution and Human Plasma.

PubMed

El-Zaher, Asmaa A; Mahrouse, Marianne A

2013-01-01

A novel, selective, and sensitive reversed phase high-performance liquid chromatography (HPLC) method coupled with fluorescence detection has been developed for the determination of tobramycin (TOB) in pure form, in ophthalmic solution and in spiked human plasma. Since TOB lacks UV absorbing chromophores and native fluorescence, pre-column derivatization of TOB was carried out using fluorescamine reagent (0.01%, 1.5 mL) and borate buffer (pH 8.5, 2 mL). Experimental design was applied for optimization of the derivatization step. The resulting highly fluorescent stable derivative was chromatographed on C18 column and eluted using methanol:water (60:40, v/v) at a flow rate of 1 mL min(-1). A fluorescence detector (λex 390 and λem 480 nm) was used. The method was linear over the concentration range 20-200 ng mL(-1). The structure of the fluorescent product was proposed, the method was then validated and applied for the determination of TOB in human plasma. The results were statistically compared with the reference method, revealing no significant difference.

Utility of Experimental Design in Pre-Column Derivatization for the Analysis of Tobramycin by HPLC—Fluorescence Detection: Application to Ophthalmic Solution and Human Plasma

PubMed Central

El-Zaher, Asmaa A.; Mahrouse, Marianne A.

2013-01-01

A novel, selective, and sensitive reversed phase high-performance liquid chromatography (HPLC) method coupled with fluorescence detection has been developed for the determination of tobramycin (TOB) in pure form, in ophthalmic solution and in spiked human plasma. Since TOB lacks UV absorbing chromophores and native fluorescence, pre-column derivatization of TOB was carried out using fluorescamine reagent (0.01%, 1.5 mL) and borate buffer (pH 8.5, 2 mL). Experimental design was applied for optimization of the derivatization step. The resulting highly fluorescent stable derivative was chromatographed on C18 column and eluted using methanol:water (60:40, v/v) at a flow rate of 1 mL min−1. A fluorescence detector (λex 390 and λem 480 nm) was used. The method was linear over the concentration range 20–200 ng mL−1. The structure of the fluorescent product was proposed, the method was then validated and applied for the determination of TOB in human plasma. The results were statistically compared with the reference method, revealing no significant difference. PMID:23700362

[Antimicrobial Effects of Iodine-Polyvinyl Alcohol Ophthalmic and Eye Washing Solution (PA * IODO) with Special Reference to its Temperature, Concentration and Time and its Preservation Stability].

PubMed

Hatano, Hiroshi; Sakamoto, Masako; Hayashi, Kazuo; Kamiya, Seigo

2015-08-01

Temperature, concentration and time are the three factors that affect the inactivation capacity of iodine antiseptics. We investigated the effect of these factors on the microbe inactivation of Iodine-Polyvinyl Alcohol ophthalmic and eye washing solution (PA * IODO), and also investigated the preservation conditions on stability of the inactivation activity of the PA * IODO. Test microbes were mixed with PA * IODO, varying the three factors. The live microbes were counted after each reaction. The effects of plugging and preservation temperature were investigated to determine the preserving stability. The inactivation capacity of PA * IODO tended to decrease in almost all microbes tested at 4 degrees C. Twenty times or less diluted PA * IODO killed almost all microbes completely. The time effect was more marked in viruses. Plugging and low-temperature made iodine concentration in diluted PA * IODO remain relatively high. The concentration of PA * IODO affected the inactivation ability more than the temperature and time, although all the three factors correlated positively to the inactivation. For preservation the diluted PA * IODO needed plugging and low temperature.

Development and validation of a stability-indicating high performance liquid chromatographic assay for benoxinate.

PubMed

Chorny, Michael; Levy, Daniel; Schumacher, Ilana; Lichaa, Chaim; Gruzman, Boris; Livshits, Oleg; Lomnicky, Yossi

2003-04-24

Benoxinate is a local anaesthetic used for ophthalmic applications. The aim of this study was to develop a rapid and simple stability-indicating method for the determination of benoxinate formulated for ophthalmic use, evaluate its long-term stability and identify its major degradation product. Benoxinate was eluted on a 10 microm Spherisorb phenyl column, 250 x 3.2 mm, with a mobile phase consisting of acetonitrile-buffer (pH 3.5) (35:65, v/v), pumped at 0.8 ml min(-1) flow rate. The buffer was composed of sodium dihydrogen phosphate (50 mM), sodium hydrogen sulfate (2.5 mM) and 1-heptanesulfonic acid sodium salt (5 mM). The analyte was quantified spectrophotometrically at 308 nm. The chromatograms of benoxinate formulations obtained by this method showed benoxinate (t = 4.5 min) well resolved from its degradation product (t = 2.3 min), which was separately identified by means of HPLC-MS as 4-amino-3-butoxybenzoic acid. The assay was demonstrated to have high accuracy, precision and linearity. The method was implemented in investigating the long-term stability of benoxinate 0.4% ophthalmic solutions. The method was found to be simple, quick and selective in determining benoxinate concentrations in fresh and aged preparations.

Identification of leachable impurities in an ophthalmic drug product originating from a polymer additive Irganox 1010 using mass spectroscopy.

PubMed

Singh, Gagandeep; Gollapalli, Ramarao; Blinder, Alejandro; Patel, Milan

2018-04-15

Pharmaceutical packaging employs a wide variety of polymers owing to their desirable features, but the compounds that could leach from the polymers into the drug products can pose serious health risks. Therefore, it is extremely important to identify such compounds so that they can be adequately quantified and evaluated for toxicological impact/safety assessments. Not only the polymer components and the additives should be considered as sources for leachable impurities, their reaction/degradation products should also be evaluated. Irganox 1010 is a common commercial antioxidant (polymer additive) used in the manufacturing of polyolefin materials for container closure systems. In our study, we identified two Irganox1010 related leachable impurities in an ophthalmic drug product using rapid and straightforward orthogonal mass spectroscopy (LC-MS and GC-MS) methods The identified impurities were 7,9-Di-tert-butyl-1 oxaspiro[4.5]deca-6,9-diene-2,8-dione and 3-[3,5-bis(tert-butyl)-1-hydroxy-4-oxocyclohexa-2,5-dienyl]propanoic acid which leached into the ophthalmic drug solution during storage. The analytical methods employed could potentially be used to identify the similar class of compounds as is or in drug products. Copyright © 2018 Elsevier B.V. All rights reserved.

Pharmacokinetic analysis of topical tobramycin in equine tears by automated immunoassay.

PubMed

Czerwinski, Sarah L; Lyon, Andrew W; Skorobohach, Brian; Léguillette, Renaud

2012-08-21

Ophthalmic antibiotic therapy in large animals is often used empirically because of the lack of pharmacokinetics studies. The purpose of the study was to determine the pharmacokinetics of topical tobramycin 0.3% ophthalmic solution in the tears of normal horses using an automated immunoassay analysis. The mean tobramycin concentrations in the tears at 5, 10, 15, 30 minutes and 1, 2, 4, 6 hours after administration were 759 (±414), 489 (±237), 346 (±227), 147 (±264), 27.6 (±28.4), 14.8 (±66.6), 6.7 (±18.6), and 23.4 (±73.4) mg/L. Mean tobramycin concentration was maintained above the MIC90 for commonly isolated bacteria for 68.5 min. A single dose of topical tobramycin resulted in therapeutic concentrations of tobramycin in the tears for 1 h after administration. Therapeutic levels of tobramycin remained in equine tears 6 times longer than was reported in rabbit tears.

21 CFR 886.1760 - Ophthalmic refractometer.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1760 Ophthalmic refractometer. (a) Identification. An ophthalmic refractometer is an automatic AC-powered device that consists of a fixation system... of the eye by measuring light reflexes from the retina. (b) Classification. Class I (general controls...

OIPAV: an integrated software system for ophthalmic image processing, analysis and visualization

NASA Astrophysics Data System (ADS)

Zhang, Lichun; Xiang, Dehui; Jin, Chao; Shi, Fei; Yu, Kai; Chen, Xinjian

2018-03-01

OIPAV (Ophthalmic Images Processing, Analysis and Visualization) is a cross-platform software which is specially oriented to ophthalmic images. It provides a wide range of functionalities including data I/O, image processing, interaction, ophthalmic diseases detection, data analysis and visualization to help researchers and clinicians deal with various ophthalmic images such as optical coherence tomography (OCT) images and color photo of fundus, etc. It enables users to easily access to different ophthalmic image data manufactured from different imaging devices, facilitate workflows of processing ophthalmic images and improve quantitative evaluations. In this paper, we will present the system design and functional modules of the platform and demonstrate various applications. With a satisfying function scalability and expandability, we believe that the software can be widely applied in ophthalmology field.

[Role of community pharmacist in the management of patients in ophthalmology].

PubMed

Delolme, M-P; Law-Ki, A; Belon, J-P; Creuzot-Garcher, C; Bron, A

2011-03-01

To assess the role of community pharmacists in ophthalmology, to evaluate the frequency of giving patients advice, and to report their difficulties in daily practice. An anonymous questionnaire consisting of 13 questions was sent to 620 community pharmacists of Burgundy (France). Pharmacists were asked about their ophthalmic products, their ophthalmic activity in giving patients advice on ocular symptoms, and patients' expectations. For analysis, community pharmacies were separated into three groups: pharmacies in rural areas (under 2000 inhabitants), pharmacies in an urban zone with fewer than 10,000 inhabitants, and pharmacies in an urban zone with more than 10,000 inhabitants. The response rate was 46.9%. Ophthalmic products were mainly glasses for presbyopia (84.5%), eye care hygiene products (76.0%), and contact lens solutions (55.3%). Ophthalmic vitamin supplements were sold by 36.8% of pharmacists, mainly in urban areas. On average, the pharmacist was consulted for ocular problems seven times a week. Acute benign symptoms were most frequent. Advice on prescriptions came next. Then, information on contact lenses and chronic ocular disease were given (cataract, glaucoma, visual acuity loss, age-related maculopathy). Finally, the pharmacist either sold the patient an ocular treatment or oriented the patient to an ophthalmologist when needed. The pharmacist and his staff are active players in providing advice on ocular diseases and taking care of patients. Moreover, pharmacists have to manage ocular therapeutics, urgent symptoms, and chronic diseases. However, in our study, 46.0% of pharmacists felt confident with their knowledge on ophthalmology, 36.4% did not give their opinion, and 7.0% were uncomfortable with some questions. Most community pharmacists mentioned a lack of continuing education from pharmaceutical companies and postgraduate education on ocular diseases and treatment, mainly for age-related maculopathy. Copyright © 2010 Elsevier Masson SAS. All rights reserved.

A comparative study of validated spectrophotometric and TLC- spectrodensitometric methods for the determination of sodium cromoglicate and fluorometholone in ophthalmic solution

PubMed Central

Saleh, Sarah S.; Lotfy, Hayam M.; Hassan, Nagiba Y.; Elgizawy, Samia M.

2013-01-01

The determination of sodium cromoglicate (SCG) and fluorometholone (FLU) in ophthalmic solution was developed by simple, sensitive and precise methods. Three spectrophotometric methods were applied: absorptivity factor (a-Factor method), absorption factor (AFM) and mean centering of ratio spectra (MCR). The linearity ranges of SCG were found to be (2.5–35 μg/mL) for (a-Factor method) and (MCR); while for (AFM), it was found to be (7.5–50 μg/mL). The linearity ranges of FLU were found to be (4–16 μg/mL) for (a-Factor method) and (AFM); while for (MCR), it was found to be (2–16 μg/mL). The mean percentage recoveries/RSD for SCG were found to be 100.31/0.90, 100.23/0.57 and 100.43/1.21; while for FLU, they were found to be 100.11/0.56, 99.97/0.35 and 99.94/0.88 using (a-Factor method), (AFM) and (MCR), respectively. A TLC-spectrodensitometric method was developed by separation of SCG and FLU on silica gel 60 F254 using chloroform:methanol:toluene:triethylamine in the ratio of (5:2:4:1 v/v/v/v) as developing system, followed by spectrodensitometric measurement of the bands at 241 nm. The linearity ranges and the mean percentage recoveries/RSD were found to be (0.4–4.4 μg/band), 100.24/1.44 and (0.2–1.6 μg/band), 99.95/1.50 for SCG and FLU, respectively. A comparative study was conducted between the proposed methods to discuss the advantage of each method. The suggested methods were validated in compliance with the ICH guidelines and were successfully applied for the determination of SCG and FLU in their laboratory prepared mixtures and commercial ophthalmic solution in the presence of benzalkonium chloride as a preservative. These methods could be an alternative to different HPLC techniques in quality control laboratories lacking the required facilities for those expensive techniques. PMID:24227962

21 CFR 886.3100 - Ophthalmic tantalum clip.

Code of Federal Regulations, 2010 CFR

2010-04-01

... blood vessels in the eye. (b) Classification. Class II (special controls). The device is exempt from the...) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3100 Ophthalmic tantalum clip. (a) Identification. An ophthalmic tantalum clip is a malleable metallic device intended to be implanted permanently...

21 CFR 886.5800 - Ophthalmic bar reader.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic bar reader. 886.5800 Section 886.5800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5800 Ophthalmic bar reader. (a...

21 CFR 886.5810 - Ophthalmic prism reader.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic prism reader. 886.5810 Section 886.5810 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5810 Ophthalmic prism reader. (a...

21 CFR 886.1415 - Ophthalmic trial lens frame.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic trial lens frame. 886.1415 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1415 Ophthalmic trial lens frame. (a) Identification. An opthalmic trial lens frame is a mechanical device intended to hold trial lenses for vision...

21 CFR 200.50 - Ophthalmic preparations and dispensers.

Code of Federal Regulations, 2010 CFR

2010-04-01

... intended for ophthalmic use, including preparations for cleansing the eyes, should be sterile. It is... use in the eye. (2) The Food and Drug Administration concludes that all such preparations, if they are... applicable to ophthalmic preparations that are regulated as medical devices. (3) The containers of ophthalmic...

Non-preserved 1% lidocaine solution has less antibacterial properties than currently available anaesthetic eye-drops.

PubMed

Labetoulle, Marc; Frau, Eric; Offret, Hervé; Nordmann, Patrice; Naas, Thierry

2002-08-01

Some anaesthetics inhibit bacterial growth, and thus may lead to low rates of positive cultures from bacterial keratitis. Antibacterial properties of lidocaine were compared with those of oxybuprocaine or tetracaine, either in current commercial eye lotions or in extemporaneous solutions. Forty-eight bacterial strains were used to determine the minimum inhibitory and bactericidal concentrations of four commercial eye lotions containing oxybuprocaine or tetracaine, of a non-ophthalmic 1% lidocaine commercial solution and of extemporaneously prepared solutions of oxybuprocaine, tetracaine, lidocaine and benzalkonium. Most strains had their growth inhibited by 0.2% oxybuprocaine or 0.4% tetracaine, which corresponds to a 1/2 dilution of the commercial eye-drops. Bacterial growth was still observed with a 1% lidocaine solution. Currently available anaesthetic eye-drops that are used before corneal specimen collection may lead to false-negative bacterial cultures. Conversely, a non-preserved 1% lidocaine solution might be more appropriate in corneal specimen collection.

Allergic Contact Dermatitis to Ophthalmic Medications: Relevant Allergens and Alternative Testing Methods.

PubMed

Grey, Katherine R; Warshaw, Erin M

Allergic contact dermatitis is an important cause of periorbital dermatitis. Topical ophthalmic agents are relevant sensitizers. Contact dermatitis to ophthalmic medications can be challenging to diagnose and manage given the numerous possible offending agents, including both active and inactive ingredients. Furthermore, a substantial body of literature reports false-negative patch test results to ophthalmic agents. Subsequently, numerous alternative testing methods have been described. This review outlines the periorbital manifestations, causative agents, and alternative testing methods of allergic contact dermatitis to ophthalmic medications.

Fluid temperature at the corneal endothelium during phacoemulsification: comparison of an ophthalmic viscosurgical device and balanced salt solution using the finite element method.

PubMed

Reepolmaha, Somporn; Limtrakarn, Wiroj; Uthaisang-Tanechpongtamb, Wanlaya; Dechaumphai, Pramote

2010-01-01

The purpose of this study was to estimate and compare the temperatures of two different anterior chamber solutions at the corneal endothelial level during phacoemulsification. An ophthalmic viscosurgical device (OVD) and balanced salt solution (BSS) were compared using the finite element method (FEM). The thermal properties of an OVD (IAL-F) and BSS were studied in an experimental setting. A computer-aided design model of ocular anatomy was created in two dimensions. The phaco needle was considered to be the only source of heat generation. Then, the FEM was used to demonstrate the transient temperature distribution in the two ocular models at 10, 20, 30, 40, 50 and 60 s. In these models, the anterior chamber was filled with IAL-F (IAL-F model) or BSS (BSS model). The heat generation rate of the phaco needle was 0.0004 cal/s/mm(2). The maximum corneal endothelial temperatures for the two models at 60 s were 52.67 and 41.57 degrees C, respectively. The experimental IAL-F model showed fewer changes in temperature for any given time and location. At larger distances from the heat source, less temperature variation was detected. Phacoemulsification is a potential heat-generating procedure performed between the delicate anterior chamber structures. During this procedure, IAL-F protects the endothelium against heat better than BSS. Copyright 2009 S. Karger AG, Basel.

Aqueous Humor Penetration and Biological Activity of Moxifloxacin 0.5% Ophthalmic Solution Alone or with Dexamethasone 0.1.

PubMed

Gomes, Rachel L R; Viana, Rodrigo Galvão; Melo, Luiz Alberto S; Cruz, Alessandro Carvalho; Suenaga, Eunice Mayumi; Kenyon, Kenneth R; Campos, Mauro

2017-03-01

To compare aqueous humor concentrations of topically applied moxifloxacin 0.5% ophthalmic solution alone or in combination with dexamethasone 0.1% and to correlate these concentrations with the minimum inhibitory concentrations (MICs) for common endophthalmitis-causing organisms. Sixty-eight patients undergoing routine phacoemulsification with intraocular lens implantation received either moxifloxacin 0.5% alone or moxifloxacin 0.5% combined with dexamethasone. For both groups, 1 drop of the test solution was instilled 4 times daily 1 day preoperatively and 1 drop 1 h preoperatively. An aqueous humor sample obtained immediately before paracentesis was submitted to high-performance liquid chromatography-tandem mass spectrometry to determine the moxifloxacin concentration. The mean concentrations of moxifloxacin were 986.6 ng/mL in the moxifloxacin with dexamethasone group and 741.3 ng/mL in the moxifloxacin group (P = 0.13). Moxifloxacin concentrations of all samples exceeded the MICs for Staphylococcus epidermidis, S. aureus, and Streptococcus pneumoniae. All samples in the moxifloxacin with dexamethasone group and 94% in the moxifloxacin group achieved the MIC for Enterococcus species. For quinolone-resistant S. aureus, the MIC was achieved in 29% in the moxifloxacin with dexamethasone group and 9% in the moxifloxacin group (P = 0.06). Aqueous humor moxifloxacin concentrations were higher when topically administrated in combination with dexamethasone compared to the moxifloxacin alone. However, this difference was not statistically significant. Nevertheless, the MICs of the most common pathogens associated with endophthalmitis were exceeded in both study groups.

The Risk of Microbial Contamination in Multiple-Dose Preservative-Free Ophthalmic Preparations.

PubMed

Saisyo, Atsuyuki; Shimono, Rima; Oie, Shigeharu; Kimura, Kazuhiro; Furukawa, Hiroyuki

2017-01-01

Multiple-dose ophthalmic preparations that do not contain preservatives carry high risks of microbial contamination. However, there are various types of hospital preparations, with different physicochemical properties. In the present study, we evaluated the association between physicochemical properties and microbial contamination in ophthalmic preparations. The investigated hospital preparations included ophthalmic preparations of physiological saline, 0.2% fluconazole, 0.5% vancomycin hydrochloride, and 2% cyclosporine. We investigated the microbial dynamics of each ophthalmic preparation and microbial contamination in ophthalmic preparations used by patients. Remarkable growth of Pseudomonas aeruginosa, Burkholderia cepacia, and Serratia marcescens was observed in ophthalmic preparations of physiological saline and 0.2% fluconazole. All tested microorganisms displayed decreased counts after inoculation in 0.5% vancomycin hydrochloride. In 2% cyclosporine, all investigated microorganisms were below the limit of detection after inoculation for 6 h. The microbial contamination rates of ophthalmic preparations used by patients were 16.7% (3/18 samples) for 0.5% vancomycin hydrochloride and 0% (0/30 samples) for 2% cyclosporine. All detected contaminants in 0.5% vancomycin hydrochloride were Candida spp., one of which was present at a level of 1×10 4 colony-forming units/mL. The storage method for in-use ophthalmic preparations should be considered on the basis of their physicochemical properties.

Two Patients with Dry Eye Disease Followed Up Using an Expression Assay of Ocular Surface Mucin.

PubMed

Machida, Yumiko; Shoji, Jun; Harada, Natsuko; Inada, Noriko

2016-01-01

We report 2 patients with dry eye disease followed up using the expression levels of ocular surface mucin. Patient 1: a 57-year-old woman with Sjögren's syndrome-associated dry eyes experienced severe dryness and foreign body sensation in both her eyes, and instilled sodium hyaluronate ophthalmic solution 0.3% about 10-15 times daily. We measured the expression levels of MUC5AC mRNA (MUC5AC) and MUC16 mRNA (MUC16) by using real-time reversed transcription polymerase chain reaction for the specimens of modified impression cytology. Expression levels of MUC5AC and MUC16 on her ocular surface were very low. Subjective symptoms and expression levels of ocular surface mucin improved after combined treatment of rebamipide (4 times daily) and fluorometholone (once daily) ophthalmic suspension. Patient 2: a 62-year-old man with chronic graft-versus-host disease-associated dry eye experienced severe foreign body sensation and developed superficial punctate keratopathy with mucous thread and filamentary keratitis. Expression level of MUC5AC was very high at baseline. Subjective symptoms and expression levels of ocular surface mucin improved by combined treatment of rebamipide (4 times daily) and fluorometholone (once daily) ophthalmic suspension. Clinical test for MUC gene expression on the ocular surface was found to be useful in the follow-up of dry eye treatment.

Thermosetting gels with modulated gelation temperature for ophthalmic use: the rheological and gamma scintigraphic studies.

PubMed

Wei, Gang; Xu, Hui; Ding, Ping Tian; Li, San Ming; Zheng, Jun Min

2002-09-18

For ophthalmic drug delivery, Pluronic F127 solutions have a phase transition temperature too low for them to be instilled into the eye at room temperature. Refrigerator storage is usually required to make administration easier, whereas the potential irritation of cold to the sensitive ocular tissues may result in poor topical bioavailability. The purpose of this study is to develop a thermosetting gel with a suitable phase transition temperature by combining Pluronic analogs and to examine the influence of incorporating mucoadhesive polysaccharide, sodium hyaluronate (HA-Na), on the ocular retention of the gel. Dynamic rheological method and single photon emission computing tomography (SPECT) technique were used to ex/in vivo evaluate the thermosetting gels, respectively. An optimized formulation containing 21% F127 and 10% F68 increased the phase transition temperature by 9 degrees C as evaluated by elasticity modulus compared to that of individual 21% F127 solution. Rheological behaviors of the Pluronic solutions showed that the combined Pluronic formulation was free flowing liquid below 25 degrees C and converted to a firm gel under the physiological condition. Furthermore, this formulation possessed the highest viscosity both before and after tear dilution at 35 degrees C. Gamma scintigraphic data demonstrated that the clearance of the thermosetting gel labeled with 99mTc-DTPA was significantly delayed with respect to the phosphate buffered solution, and at least a threefold increase of the corneal residence time was achieved. However, no further improvement in the ocular retention was observed when adding HA-Na into the thermosetting gel due to the substantially decreased gel strength. Copyright 2002 Elsevier Science B.V.

Scintigraphic studies on the corneal residence of a New Ophthalmic Delivery System (NODS): rate of clearance of a soluble marker in relation to duration of pharmacological action of pilocarpine.

PubMed Central

Greaves, J L; Wilson, C G; Birmingham, A T; Richardson, M C; Bentley, P H

1992-01-01

1. A gamma scintigraphic study has been carried out on the precorneal residence and pharmacodynamic action of a radiolabelled New Ophthalmic Delivery System (NODS) containing pilocarpine nitrate in 12 healthy volunteers. 2. The NODS was radiolabelled with the soluble marker technetium-99m labelled diethylenetriaminepentaacetic acid, to mark the release characteristics of soluble drugs contained within the matrix. 3. The relationship between the precorneal residence time of the marker and the duration of drug effect on intraocular pressure and pupil diameter was monitored. Results obtained following administration of the NODS were compared with those obtained after administration of a 25 microliters drop of a 2% w/v pilocarpine nitrate solution. Each formulation was administered to one eye only, the other eye acting as a control. 4. Dissolution of the radiolabel from the NODS in vivo showed considerable intersubject variation with half-times of dissolution ranging from 46 s to 833 s (mean +/- s.d. -280 +/- 217 s), the mean (+/- s.d.) half-time of clearance of the radiolabel from the NODS and corneal region of interest was 406 +/- 214 s whereas the radiolabelled solution had a mean (+/- s.d.) ocular surface residence time of 2.9 +/- 1.5 s. 5. Pupil diameter and intraocular pressure were measured for 5 h post-administration of the NODS and the solution. After both treatments pupil diameter was significantly constricted in the test eye when compared with the control eye (P less than 0.001; Student's paired t-test). Pupil diameter was constricted by 52% after administration of the NODS and by 35% after administration of the solution.(ABSTRACT TRUNCATED AT 250 WORDS) Images Figure 1 PMID:1389932

Scintigraphic studies on the corneal residence of a New Ophthalmic Delivery System (NODS): rate of clearance of a soluble marker in relation to duration of pharmacological action of pilocarpine.

PubMed

Greaves, J L; Wilson, C G; Birmingham, A T; Richardson, M C; Bentley, P H

1992-06-01

1. A gamma scintigraphic study has been carried out on the precorneal residence and pharmacodynamic action of a radiolabelled New Ophthalmic Delivery System (NODS) containing pilocarpine nitrate in 12 healthy volunteers. 2. The NODS was radiolabelled with the soluble marker technetium-99m labelled diethylenetriaminepentaacetic acid, to mark the release characteristics of soluble drugs contained within the matrix. 3. The relationship between the precorneal residence time of the marker and the duration of drug effect on intraocular pressure and pupil diameter was monitored. Results obtained following administration of the NODS were compared with those obtained after administration of a 25 microliters drop of a 2% w/v pilocarpine nitrate solution. Each formulation was administered to one eye only, the other eye acting as a control. 4. Dissolution of the radiolabel from the NODS in vivo showed considerable intersubject variation with half-times of dissolution ranging from 46 s to 833 s (mean +/- s.d. -280 +/- 217 s), the mean (+/- s.d.) half-time of clearance of the radiolabel from the NODS and corneal region of interest was 406 +/- 214 s whereas the radiolabelled solution had a mean (+/- s.d.) ocular surface residence time of 2.9 +/- 1.5 s. 5. Pupil diameter and intraocular pressure were measured for 5 h post-administration of the NODS and the solution. After both treatments pupil diameter was significantly constricted in the test eye when compared with the control eye (P less than 0.001; Student's paired t-test). Pupil diameter was constricted by 52% after administration of the NODS and by 35% after administration of the solution.(ABSTRACT TRUNCATED AT 250 WORDS)

16 CFR 315.2 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-01-01

... contact lens fitting. Ophthalmic goods are contact lenses, eyeglasses, or any component of eyeglasses. Ophthalmic services are the measuring, fitting, and adjusting of ophthalmic goods subsequent to an eye...

16 CFR 315.2 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... contact lens fitting. Ophthalmic goods are contact lenses, eyeglasses, or any component of eyeglasses. Ophthalmic services are the measuring, fitting, and adjusting of ophthalmic goods subsequent to an eye...

16 CFR 315.2 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-01-01

... contact lens fitting. Ophthalmic goods are contact lenses, eyeglasses, or any component of eyeglasses. Ophthalmic services are the measuring, fitting, and adjusting of ophthalmic goods subsequent to an eye...

16 CFR 315.2 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-01-01

... contact lens fitting. Ophthalmic goods are contact lenses, eyeglasses, or any component of eyeglasses. Ophthalmic services are the measuring, fitting, and adjusting of ophthalmic goods subsequent to an eye...

16 CFR 315.2 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-01-01

... contact lens fitting. Ophthalmic goods are contact lenses, eyeglasses, or any component of eyeglasses. Ophthalmic services are the measuring, fitting, and adjusting of ophthalmic goods subsequent to an eye...

Eye health care in Hungary.

PubMed

Németh, J; Molnár, F; Kocur, I

2002-01-01

To describe eye health-care services provided by in patient Departments of Ophthalmology in Hungary as of 1998. A standardised questionnaire was sent to all Hungarian in-patient ophthalmic departments. The response rate was 100%, and data from six university departments and 56 hospitals with ophthalmic units are summarised. During the 12-month period, a total of 78,008 ophthalmic operations were performed, by 489 ophthalmologists. They worked in 62 in-patient ophthalmic units having a total of 1952 beds. The cataract rate was 3564 operations per million inhabitants; intraocular lens implantation was performed on 97% of the cases. There were 591 corneal transplants, 1698 operations for retinal detachment and 510 vitrectomies for diabetic eye complications. The level of ophthalmic care in Hungary, judged on the basis of key objective parameters including number of ophthalmic specialists, number of ophthalmic beds, and the rates of surgery, generally conforms to standards prevailing in Western Europe, in spite of financial difficulties and the consequent lack of investment in new equipment and instruments, both major and minor.

Thin Film Coating Technology For Ophthalmic Lenses

NASA Astrophysics Data System (ADS)

Guenther, K. H.

1986-05-01

Coating of ophthalmic lenses is an application of high-vacuum coating technology which must satisfy not only physical and technical requirements but also customer demands with respect to aesthetics, color fidelity, and exchangeability of coated ophthalmic lenses. Because this application caters specifically to the consumer market, ophthalmic lenses are subject to certain fashion trends which frequently require quick adaptation of the coating technique. The state-of-the-art of ophthalmic lens coating is reviewed in this paper, with particular emphasis on the durability requirements in daily use by untrained consumers as well as on the applicable testing methods.

What Is an Ophthalmologist?

MedlinePlus

... medical tests and minor office surgery. Ophthalmic Registered Nurse These clinicians have undergone special nursing training and ... with hospital or office surgery. Some ophthalmic registered nurses also serve as clinic or hospital administrators. Ophthalmic ...

Molecular Solutions to Low Vision Resulting from Battlefield Injuries. Addendum

DTIC Science & Technology

2009-05-01

determining how to minimize dry eye after LASIK refractive surgery by developing new tests to predict pre-disposition to refractive surgery induced dry eye...enrolled a total of 132 subjects. Three withdrew without treatment leaving 129 enrolled - 128 have been treated (70 PRK and 58 LASIK ) and 1 is scheduled...granulomatous anterior uveitis OS 2 weeks following uncomplicated LASIK . The subject was treated with Prednisolone Acetate 1.0% ophthalmic suspension

Evaluation of the effectiveness of ophthalmic assistants as screeners for glaucoma in North India

PubMed Central

Sinha, S K; Astbury, N

2011-01-01

Aim To assess whether ophthalmic assistants are effective in screening people for glaucoma in India. Methodology The study subjects were examined by both trained ophthalmic assistants and an ophthalmologist in both hospital and community settings. Specific tests for the diagnosis of glaucoma suspects included visual field examination using frequency doubling technology perimetry, intraocular pressure measurement (Tonopen), A-scan central anterior chamber depth measurement and dilated optic disc examination. The findings recorded by the ophthalmic assistants were masked to the ophthalmologist to avoid measurement bias. Results In the hospital setting, there was a substantial level of agreement between the ophthalmic assistants and the ophthalmologist in the diagnosis of glaucoma suspects (89.29%, k=0.7, 95% confidence interval (CI)=0.54–0.86). The diagnostic accuracy of the ophthalmic assistants in detecting glaucoma suspects was high for sensitivity (95.2%, 95% CI=91.4–97.7%) but lower for specificity at 71.4% (95% CI=60.0–78.7%). In the community setting, there was a moderate level of agreement between the ophthalmic assistants and the ophthalmologist in the diagnosis of glaucoma suspects (78.23%, k=0.50, 95% CI=0.37–0.64). The diagnostic accuracy of the ophthalmic assistants in detecting glaucoma suspects was moderate for sensitivity (82.9, 95% CI=69.7–91.5%) but lower for specificity at 76.8% (95% CI=72.7–79.5%). Conclusion Ophthalmic assistants can be used for opportunistic case detection of glaucoma suspects in the community. Structured training of the ophthalmic assistants together with enhanced clinical experience would improve their performance in detecting glaucoma suspects in the community. PMID:21720416

Referral patterns to an ophthalmic outpatient clinic by general practitioners and ophthalmic opticians and the role of these professionals in screening for ocular disease.

PubMed

Harrison, R J; Wild, J M; Hobley, A J

1988-11-05

Case notes of 1113 consecutive new patients referred to a consultant ophthalmologist at a district general hospital were reviewed to determine the source and efficacy of referrals and the current screening practices of general practitioners and ophthalmic opticians. General practitioners initiated referral in 546 cases (49%) and ophthalmic opticians referral in 439 (39%). Visual loss or visual disturbance was the most important single reason for referral (345 cases; 31%), followed by suspected glaucoma (145 cases; 13%), abnormalities of binocular vision (140; 12.5%), disorders of eyelids or ocular adnexa (127; 11%), and red eye (86; 8%). General practitioners referred many more patients with disorders of the eyelids and adnexa and ophthalmic opticians many more patients with suspected glaucoma. Ophthalmic opticians were far more likely than general practitioners to refer patients with suspected glaucoma correctly. A total of 180 patients (16%) were referred from ocular screening, in 149 cases by ophthalmic opticians and in 10 by general practitioners. Seventy patients had glaucoma or incomplete features of glaucoma, all of them referred by ophthalmic opticians. Of eight diabetic patients referred by ophthalmic opticians, three had asymptomatic disease and in two diabetes was diagnosed as a result of ocular screening. No patient was referred for asymptomatic diabetic retinopathy from screening by general practitioners. Ophthalmic opticians were more likely than general practitioners to diagnose retinopathy requiring photocoagulation. Use of a community based service to screen for glaucoma could save unnecessary consultant outpatient appointments. A similar service could facilitate detection of diabetic retinopathy at a stage when treatment is most effective.

Referral patterns to an ophthalmic outpatient clinic by general practitioners and ophthalmic opticians and the role of these professionals in screening for ocular disease.

PubMed Central

Harrison, R. J.; Wild, J. M.; Hobley, A. J.

1988-01-01

Case notes of 1113 consecutive new patients referred to a consultant ophthalmologist at a district general hospital were reviewed to determine the source and efficacy of referrals and the current screening practices of general practitioners and ophthalmic opticians. General practitioners initiated referral in 546 cases (49%) and ophthalmic opticians referral in 439 (39%). Visual loss or visual disturbance was the most important single reason for referral (345 cases; 31%), followed by suspected glaucoma (145 cases; 13%), abnormalities of binocular vision (140; 12.5%), disorders of eyelids or ocular adnexa (127; 11%), and red eye (86; 8%). General practitioners referred many more patients with disorders of the eyelids and adnexa and ophthalmic opticians many more patients with suspected glaucoma. Ophthalmic opticians were far more likely than general practitioners to refer patients with suspected glaucoma correctly. A total of 180 patients (16%) were referred from ocular screening, in 149 cases by ophthalmic opticians and in 10 by general practitioners. Seventy patients had glaucoma or incomplete features of glaucoma, all of them referred by ophthalmic opticians. Of eight diabetic patients referred by ophthalmic opticians, three had asymptomatic disease and in two diabetes was diagnosed as a result of ocular screening. No patient was referred for asymptomatic diabetic retinopathy from screening by general practitioners. Ophthalmic opticians were more likely than general practitioners to diagnose retinopathy requiring photocoagulation. Use of a community based service to screen for glaucoma could save unnecessary consultant outpatient appointments. A similar service could facilitate detection of diabetic retinopathy at a stage when treatment is most effective. PMID:3144331

Trends in ophthalmic antimicrobial utilization pattern in Bahrain between 1993 and 2000: a resurgence of chloramphenicol?

PubMed

Jassim Al Khaja, K A; Sequeira, R R; Mathur, V S

2003-01-01

The occurrence of aplastic anemia following topical administration of ophthalmic chloramphenicol is controversial and debated internationally. We have determined the influence of such debate on the utilization of ophthalmic chloramphenicol in Bahrain, through studying the utilization patterns of ophthalmic antimicrobial preparations by the Ministry of Health, with an emphasis on chloramphenicol, between 1993 and 2000. Cost-implications of these patterns are examined. Information on the annual purchase of ophthalmic antimicrobial drug preparations and their unit price was obtained from the Directorate of Materials Management, Ministry of Health, and analyzed. In 1993, the 3 most commonly purchased ophthalmic antibacterial preparations were oxytetracycline 1% eye ointment (40.1%); sulfacetamide 10% and 20% eye drops (25.3%); and chloramphenicol 0.5% eye drops and 1% eye ointment (10.8%). In 2000, oxytetracycline remained the most frequently purchased preparation (33%), followed by chloramphenicol (21.2%). Between 1993 and 1999, chloramphenicol purchases fluctuated between 10% to 16.4% with a remarkable increase to 21.2%, in 2000. Chloramphenicol accounted for 8.6% and 15.1% of cost of total ophthalmic preparations purchased in 1993 and 2000, respectively. Despite continued concerns of potential risks of ophthalmic chloramphenicol, this preparation is extensively utilized in Bahrain. We are of the opinion that for minor infections, chloramphenicol ophthalmic preparations should be replaced by safer alternatives. Further, we recommend that their use be reserved for ocular infections that are resistant to other antimicrobials, and that ophthalmologists, at the secondary care level, should supervise such treatment.

Digital mobile telephones and interference of ophthalmic equipment.

PubMed

Ang, G S; Lian, P; Ng, W S; Whyte, I; Ong, J M

2007-01-01

To assess the effect of mobile telephone electromagnetic interference on electronic ophthalmic equipment. Prospective audit with mobile telephones placed at distances of 3 m, 1 m, and 30 cm from, and in contact with, electronic ophthalmic equipment. Any interruption or cessation of the function of the ophthalmic device was assessed with the mobile telephones in standby, and in dialling or receiving modes. Any alterations of displayed digital figures or numbers were also assessed. A total of 23 electronic ophthalmic devices in two hospital ophthalmology outpatient departments were evaluated. All six mobile telephones used, and 22 (95.7%) of the 23 ophthalmic equipment evaluated had the Conformité Européene (CE) mark. No device showed any interruption or cessation of function. There were no alterations of displayed digital figures or numbers. The only effect of any kind was found with four instruments (1 non-CE marked), where there was temporary flickering on the screen, and only occurred when the mobile telephones were dialling or receiving at a distance of 30 cm or less from the instruments. This study shows that among the electronic ophthalmic devices tested, none suffered failure or interruption of function, from mobile telephone interference. Although not comprehensive for all ophthalmic equipment, the results question the need for a complete ban of mobile telephones in ophthalmic departments. It highlights the need for a controlled, objectively measured study of the clinically relevant effects of mobile telephones in the ophthalmology outpatient setting.

A workforce in crisis: a case study to expand allied ophthalmic personnel.

PubMed

Astle, William; Simms, Craig; Anderson, Lynn

2016-08-01

To examine how the development of allied ophthalmic personnel training programs affects human resource capacity. Using a qualitative case study method conducted at a single Ontario institution, this article describes 6 years of establishing a 2-tiered allied ophthalmic personnel training program. The Kingston Ophthalmic Training Centre participated in the study with 8 leadership and program graduate interviews. To assess regional eye health workforce needs, a case study and iterative process used triangulations of the literature, case study, and qualitative interviews with stakeholders. This research was used to develop a model for establishing allied ophthalmic personnel training programs that would result in expanding human resource capacity. Current human resource capacity development and deployment is inadequate to provide the needed eye care services in Canada. A competency-based curriculum and accreditation model as the platform to develop formal academic training programs is essential. Access to quality eye care and patient services can be met by task-shifting from ophthalmologists to appropriately trained allied ophthalmic personnel. Establishing formal training programs is one important strategy to supplying a well-skilled, trained, and qualified ophthalmic workforce. This initiative meets the criteria required for quality, relevance, equity, and cost-effectiveness to meet the future demands for ophthalmic patient care. Copyright © 2016 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.

Cyclopentolate Ophthalmic

MedlinePlus

... e.g., use sunglasses). Cyclopentolate may make your eyes sensitive to sunlight.you should know that ophthalmic cyclopentolate contains benzalkonium chloride, which can be absorbed by soft contact lenses. If you wear contact lenses, remove them before instilling ophthalmic cyclopentolate.

The effect of latanoprost on vitiligo: a preliminary comparative study.

PubMed

Anbar, Tag S; El-Ammawi, Tarek S; Abdel-Rahman, Amal T; Hanna, Michel R

2015-01-01

Latanoprost (LT), a prostaglandin F 2alpha (PGF2a ) analogue used in the treatment of glaucoma, was found to induce skin pigmentation in guinea pigs in addition to its known periocular and iridal pigmentation side effects. This study aims to evaluate the efficacy of topical LT in the induction of skin repigmentation in patients with vitiligo and to compare its potency with narrow band ultraviolet (UV) B (NB-UVB). The result of their combination was also assessed. This study involved 22 patients with bilateral and symmetrical vitiligo lesions, stable for the last three months, divided into three groups: group I, to evaluate LT vs. placebo; group II, to evaluate LT vs. NB-UVB; and group III, to evaluate the effect of their combination. The response to treatment was evaluated by taking photographic records of the treated lesions with follow-up photography every two weeks. After three months, assessment of the degree and extent of repigmentation was performed. Follow-up assessment was done six months after termination of the trial for the persistence of pigmentation, recurrence, or development of any side effects. LT was found to be better than placebo and comparable with the NB-UVB in inducing skin repigmentation. This effect was enhanced by the addition of NB-UVB. LT could be a promising treatment for vitiligo, especially the periocular variant. Its effect on skin repigmentation could be enhanced by NB-UVB exposure. © 2014 The International Society of Dermatology.

Impact of patient access to Internet health records on glaucoma medication: randomized controlled trial.

PubMed

Kashiwagi, Kenji; Tsukahara, Shigeo

2014-01-15

Glaucoma is one of the leading causes of blindness. Reduction of intraocular pressure is the only proven way to prevent progression of glaucomatous optic neuropathy. The majority of glaucoma patients need to use antiglaucoma ophthalmic solutions over the course of their life. Thus, good adherence and persistency of glaucoma treatment are important factors for better glaucoma care. The purpose of this study was to investigate the impact of an Internet-based glaucoma care support system on glaucoma medication use. Patients were randomly divided into two groups. The non-Internet access (NIA) group consisted of patients who had access to the Internet-based glaucoma care support system during the 4-year period only when they were examined by ophthalmologists. The Internet access (IA) group consisted of patients who had the same Internet-based glaucoma care support system access as the NIA group for the first 2 years following enrollment but who were also given free access to the glaucoma care support system for the remaining 2 years. Changes in glaucoma medication use were investigated. In total, 81 patients in the IA group and 90 patients in the NIA group satisfied the study protocol. The number of antiglaucoma ophthalmic solutions used during the study period significantly increased in the NIA group (P<.03) but not in the IA group. The percentages of patients with unchanged, increased, and decreased antiglaucoma ophthalmic solution use during the study period were 61.1% (55/90), 17.8% (16/90), and 3.3% (3/90), respectively, in the NIA group, and 56.8% (46/81), 8.6% (7/81), and 13.6% (11/81), respectively, in the IA group (P<.001). Internet access significantly shifted from an increasing intraocular pressure trend to a decreasing trend in the IA group (P=.002) among the patients who did not have any medication changes. Allowing patients to browse their medical data may reduce the use and improve the effectiveness of glaucoma medication. UMIN-CTR Clinical Trial Number: UMIN000006982; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000008238&language=E (Archived by WebCite at http://www.webcitation.org/6MRPQeEAv).

Conjunctiva-Associated Lymphoid Tissue (CALT) Reactions to Antiglaucoma Prostaglandins with or without BAK-Preservative in Rabbit Acute Toxicity Study

PubMed Central

Liang, Hong; Baudouin, Christophe; Labbe, Antoine; Riancho, Luisa; Brignole-Baudouin, Françoise

2012-01-01

Conjunctiva-associated lymphoid tissue (CALT) is closely associated with ocular surface immunity. This study investigated the effects of antiglaucoma prostaglandin analogs with or without benzalkonium chloride (BAK) preservative on organized CALT using an acute toxic model. A total of 48 albino rabbits were used and seven groups of treatments were constituted. Solutions (50 µl) of PBS, 0.02%BAK, 0.02%BAK+latanoprost, 0.015%BAK+travoprost, 0.005%BAK+bimatoprost, BAK-freetravoprost preserved with the SofZia® system or BAK-freetafluprost were instilled 15 times at 5-min intervals in both eyes. CALT changes were analyzed using in vivo confocal microscopy (IVCM), immunohistology in cryosections for detecting MUC-5AC+ mucocytes and CD45+ hematopoietic cells. Antiglaucoma eye drops stimulated inflammatory cell infiltration in the CALT, and seemed to be primarily related to the concentration of their BAK content. The CALT reaction after instillation of BAK-containing eye drops was characterized by inflammatory cell infiltration in the dome and intrafollicular layers and by cell circulation inside the lymph vessels. CD45 was strongly expressed in the CALT after instillation of all BAK-containing solutions at 4 h and decreased at 24 h. The number of MUC-5AC+ mucocytes around the CALT structure decreased dramatically after instillation of BAK-containing solutions. This study showed for the first time the in vivo aspect of rabbit CALT after toxic stimuli, confirming the concentration-dependent toxic effects of BAK. IVCM-CALT analysis could be a pertinent tool in the future for understanding the immunotoxicologic challenges in the ocular surface and would provide useful criteria for evaluating newly developed eye drops. PMID:22442734

Ophthalmic adverse drug reactions to systemic drugs: a systematic review.

PubMed

Miguel, Ana; Henriques, Filipe; Azevedo, Luís Filipe; Pereira, Altamiro Costa

2014-03-01

To perform a comprehensive and systematic review regarding ophthalmic adverse drug reactions (ADRs) to systemic drugs to: (i) systematically summarize existing evidence, (ii) identify areas, ophthalmic ADRs or drugs that lacked systematization or assessment (namely drugs with original studies characterizing specific ophthalmic ADRs but without causality assessment nor without meta-analysis). Systematic review of several electronic databases (last search 1/7/2012): Medline, SCOPUS, ISI web of knowledge, ISI Conference Proceedings, International Pharmaceutical Abstracts and Google scholar. Search query included: eye, ocular, ophthalmic, ophthalmology, adverse and reaction. Inclusion criteria were: (i) Primary purpose was to assess an ophthalmic ADR to a systemic medication; (ii) Patient evaluation performed by an ophthalmologist; (iii) Studies that specified diagnostic criteria for an ocular ADR. Different types of studies were included and analyzed separately. Two independent reviewers assessed eligibility criteria, extracted data and evaluated risk of bias. From 562 studies found, 32 were included (1 systematic review to sildenafil, 11 narrative reviews, 1 trial, 1 prospective study, 6 transversal studies, 6 spontaneous reports and 6 case series). Drugs frequently involved included amiodarone, sildenafil, hydroxychloroquine and biphosphonates. Frequent ophthalmic ADRs included: keratopathy, dry eye and retinopathy. To increase evidence about ophthalmic ADRs, there is a need for performing specific systematic reviews, applying strictly the World Health Organization's (WHO) definition of ADR and WHO causality assessment of ADRs. Some ophthalmic ADRs may be frequent, but require ophthalmological examination; therefore, ophthalmologists' education and protocols of collaboration between other specialties whenever they prescribe high-risk drugs are suggestions for the future. Copyright © 2014 John Wiley & Sons, Ltd.

International Council of Ophthalmology: Refocusing Ophthalmic Education in the Asia-Pacific Region and Beyond.

PubMed

Golnik, Karl; Mayorga, Eduardo; Spivey, Bruce; Ritch, Robert; Gauthier, Tina-Marie

2012-01-01

The International Council of Ophthalmology (ICO) is a global organization with a regional focus. Working in partnership with supranational and ICO member societies, the ICO is building a "World Alliance for Sight" to improve access to the highest-quality eye care worldwide. Designed to preserve and restore vision on an international scale, the ICO initiative, "Refocusing Ophthalmic Education," enhances ophthalmic education of residents, subspecialists, medical students, and allied eye care personnel by redefining the most effective ways to teach and in creating beneficial educational opportunities. The "Teaching the Teachers" program helps ophthalmic educators incorporate more effective methods of training and continuing professional development to meet societal needs, achieved in part through regional courses for residency program directors; symposia, and keynote talks presented by ICO's World Ophthalmology Educational Colloquium, Conferences for Ophthalmic Educators, and ophthalmic surgical competency rubrics. Recognizing that standardized curricula are essential for consistent ophthalmic education, the ICO has developed a curricular framework whereby goals, expectations, knowledge base, competencies, and technical training are delineated. The ICO is defining worldwide models of team training and compiling best practice, which will include training-program accreditation to ensure improvement in the education of ophthalmologists. International Council of Ophthalmology Web-based teaching courses, a Webinar Network, and a technology blog further support information and communication technologies for teaching and learning. At the ICO's Center for Ophthalmic Educators (educators.icoph.org), trainers will find valuable teaching resources in multiple languages as well as ways to share ideas and collaborate with peers and other ophthalmic educators.

Comparison of the clinical efficacy and tolerability of olopatadine hydrochloride 0.1% ophthalmic solution and loteprednol etabonate 0.2% ophthalmic suspension in the conjunctival allergen challenge model.

PubMed

Berdy, Gregg J; Stoppel, Juan O; Epstein, Arthur B

2002-06-01

Olopatadine hydrochloride 0.1% ophthalmic solution and loteprednol etabonate 0.2% ophthalmic suspension are topical antiallergic agents indicated for treatment of the signs and symptoms of allergic conjunctivitis and seasonal allergic conjunctivitis (SAC), respectively. The purpose of this study was to compare the efficacy and tolerability of olopatadine, loteprednol, and placebo in inhibiting the early-phase allergic reaction (within 30 minutes) after conjunctival allergen challenge (CAC). This was a single-center, randomized, double-masked, parallel-controlled CAC study. It consisted of 3 visits, with CAC performed at visit 1, confirmation and randomization at visit 2, and evaluation of the treatments at visit 3. Subjects with a history of allergic conjunctivitis were randomized to receive olopatadine, loteprednol, or placebo in a 2:2:1 ratio. Because loteprednol requires a loading period to achieve maximum efficacy, subjects assigned to this treatment received loteprednol QID bilaterally for a 14-day period; the olopatadine and placebo groups received placebo QID bilaterally during this period. At the evaluation visit, subjects received 1 drop of the assigned treatment in each eye. Fifteen minutes later, they were challenged with allergen. Subjects evaluated itching at 3, 5, and 10 minutes after challenge using a standardized 5-point scale; the investigator evaluated redness at 10, 15, and 20 minutes after challenge. Intraocular pressure (IOP) was measured at baseline and after the 14-day loading period. Nonparametric analyses were performed on the change from visit 2 to visit 3 in mean itching and redness scores for each time point, and on the change in mean IOP from visit 1 to visit 3. Fifty subjects (86% white; 42% male, 58% female; age range, 21-71 years) were enrolled and completed the study (20 olopatadine, 20 loteprednol, 10 placebo). The allergens to which subjects reacted were ragweed pollen (40%), cat hair or dander (30%), grass pollen (24%), and tree pollen (6%). The difference in inhibition of itching and redness was clinically significant (> or =1 unit difference) and statistically significant (P < 0.05) in favor of olopatadine compared with loteprednol at all 3 time points. The loteprednol group had a statistically significant increase in IOP after 2 weeks of treatment (P < 0.001). In the population studied, olopatadine was more efficacious than loteprednol in reducing the acute signs and symptoms of SAC during the early phase of the ocular allergic reaction and appeared to be better tolerated.

Alternative methods of ophthalmic treatment in Russia.

PubMed

Vader, L

1994-04-01

Russian ophthalmic nurses and physicians are using alternative methods of treatment to supplement traditional eye care. As acupuncture and iridology become more popular in the United States, ophthalmic nurses need to be more knowledgeable about these treatments and the implications for patients.

The international council of ophthalmology: vision for ophthalmic education in an interdependent world.

PubMed

Lee, Andrew G; Golnik, Karl C; Tso, Mark O M; Spivey, Bruce; Miller, Kathleen; Gauthier, Tina-Marie

2012-10-01

To describe the emerging strategic global perspective of the International Council of Ophthalmology (ICO) efforts in ophthalmic education. A global perspective describing how the development of sophisticated educational tools in tandem with information technology can revolutionize ophthalmic education worldwide. Review of ICO educational tools, resources, and programs that are available to ophthalmic educators across the globe. With the explosive growth of the Internet, the ability to access medical information in the most isolated of locations is now possible. Through specific ICO initiatives, including the ICO curricula, the "Teaching the Teachers" program, and the launching of the new ICO Center for Ophthalmic Educators, the ICO is providing ophthalmic educators across the globe with access to standardized but customizable educational programs and tools to better train ophthalmologists and allied eye care professionals throughout the world. Access to educational tools and strengthening of global learning will help providers meet the goals of VISION 2020 and beyond in eliminating avoidable blindness. It is the intent of the ICO that its programs for ophthalmic educators, including conferences, courses, curricula, and online resources, result in better-trained ophthalmologists and eye care professionals worldwide. Copyright © 2012 Elsevier Inc. All rights reserved.

16 CFR 456.1 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-01-01

... the use of objective or subjective tests. (c) Ophthalmic goods are eyeglasses, or any component of eyeglasses, and contact lenses. (d) Ophthalmic services are the measuring, fitting, and adjusting of... Practices FEDERAL TRADE COMMISSION TRADE REGULATION RULES OPHTHALMIC PRACTICE RULES (EYEGLASS RULE) § 456.1...

16 CFR 456.1 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-01-01

... the use of objective or subjective tests. (c) Ophthalmic goods are eyeglasses, or any component of eyeglasses, and contact lenses. (d) Ophthalmic services are the measuring, fitting, and adjusting of... Practices FEDERAL TRADE COMMISSION TRADE REGULATION RULES OPHTHALMIC PRACTICE RULES (EYEGLASS RULE) § 456.1...

16 CFR 456.1 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-01-01

... the use of objective or subjective tests. (c) Ophthalmic goods are eyeglasses, or any component of eyeglasses, and contact lenses. (d) Ophthalmic services are the measuring, fitting, and adjusting of... Practices FEDERAL TRADE COMMISSION TRADE REGULATION RULES OPHTHALMIC PRACTICE RULES (EYEGLASS RULE) § 456.1...

76 FR 23640 - Small Business Size Standards: Waiver of the Nonmanufacturer Rule

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-27

... (Ophthalmic Instruments, Equipment, and Supplies), under the North American Industry Classification System...(a) Business Development (BD) program. DATES: Comments and source information must be submitted May... under PSC 6540 (Ophthalmic Instruments, Equipment, and Supplies), under NAICS code 339115 (Ophthalmic...

75 FR 36101 - Dermatologic and Ophthalmic Drugs Advisory Committee; Cancellation

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-24

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Dermatologic and Ophthalmic Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee...

21 CFR 886.4350 - Manual ophthalmic surgical instrument.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Manual ophthalmic surgical instrument. 886.4350 Section 886.4350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor...

Association of Midfacial Fractures with Ophthalmic Injury

PubMed Central

Politis, Constantinus; Kluyskens, Alexandra; Dormaar, Titiaan

2017-01-01

The aim of this study is to evaluate the incidence of ophthalmic complications following midfacial fractures and investigate its relation to surgical or nonsurgical treatment. This article is a retrospective study, describing the spectrum and incidence of ophthalmic injury in 106 patients presenting with midfacial fractures at the Department of Oral and Maxillofacial Surgery of the University Hospitals Leuven over a period of 16 months (January 2013 to April 2014). The mean age of the patients was 45.6 years with a gender distribution of 68 men and 38 women. The main cause of trauma was road traffic accidents. Forty-one patients suffered an ophthalmic injury following the fracture. Twelve of them had a persistent ophthalmic problem. Ophthalmic examination is necessary during the initial management. The time window for preservation of sight is small and treatment should be started immediately. Development of an emergency trauma scale that includes fractures, symptoms of visual impairment, and patient history is recommended and should stimulate a multidisciplinary approach of complex cases. PMID:28523083

ANAESTHESIA FOR OPHTHALMIC SURGICAL PROCEDURES.

PubMed

Onakpoya, O H; Asudo, F D; Adeoye, A O

2014-03-01

Ophthalmic surgical procedures are performed under anaesthesia to enhance comfort and cooperation of patient. To review factors influencing the choice of anaesthesia for ophthalmic surgical procedures. Restrospective descriptive study. Eye unit of a tertiary hospital. All patients who had ophthalmic surgeries in the operating theatre from January 2002 to December 2009. Two hundred and ninety ophthalmic surgeries were carried out during the study period. Age range was 1-95 years and mean of 61.0 ± 1.9; most (55%) were elderly while 4.8% were children. One hundred and fourty seven (50.7%) were males, 143(49.3%) females; male:female of 1.03:1. Local anaesthesia was the more commonly (92.1%) employed while general anaesthesia was used in 23(7.9%) patients. General anaesthesia was used more frequently (71.4%) in children compared to other age groups; the mean age and standard error of means for patients who had general anaesthesia (27.2 /5.4 years) is smaller compared to 63.9/0.93 years for patients who had local anaesthesia (p < 0.0001). Regional anaesthesia was the most frequently used for all types of procedures except for eye wall repairs in which general anaesthesia was used for 71.4% of patients (p < 0.0001). General anaesthesia was indicated in seven (41.2%) of emergency ophthalmic surgical procedures as compared to 16 (5.9%) of elective ophthalmic procedures P < 0.0001. General anaesthesia was more commonly employed in children, eye wall repairs and emergency ophthalmic surgical procedures.

21 CFR 524.390d - Chloramphenicol-prednisolone ophthalmic ointment.

Code of Federal Regulations, 2010 CFR

2010-04-01

... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS § 524.390d Chloramphenicol-prednisolone ophthalmic ointment. (a) Specifications. Each gram...) Limitations. Therapy for cats should not exceed 7 days, prolonged use in cats may produce blood dyscrasia. As...

Laser technologies in ophthalmic surgery

NASA Astrophysics Data System (ADS)

Atezhev, V. V.; Barchunov, B. V.; Vartapetov, S. K.; Zav'yalov, A. S.; Lapshin, K. E.; Movshev, V. G.; Shcherbakov, I. A.

2016-08-01

Excimer and femtosecond lasers are widely used in ophthalmology to correct refraction. Laser systems for vision correction are based on versatile technical solutions and include multiple hard- and software components. Laser characteristics, properties of laser beam delivery system, algorithms for cornea treatment, and methods of pre-surgical diagnostics determine the surgical outcome. Here we describe the scientific and technological basis for laser systems for refractive surgery developed at the Physics Instrumentation Center (PIC) at the Prokhorov General Physics Institute (GPI), Russian Academy of Sciences.

21 CFR 524.1484 - Neomycin sulfate ophthalmic and topical dosage forms.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Neomycin sulfate ophthalmic and topical dosage forms. 524.1484 Section 524.1484 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... NEW ANIMAL DRUGS § 524.1484 Neomycin sulfate ophthalmic and topical dosage forms. ...

21 CFR 524.1044 - Gentamicin sulfate ophthalmic and topical dosage forms.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Gentamicin sulfate ophthalmic and topical dosage forms. 524.1044 Section 524.1044 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... NEW ANIMAL DRUGS § 524.1044 Gentamicin sulfate ophthalmic and topical dosage forms. ...

21 CFR 524.1484 - Neomycin sulfate ophthalmic and topical dosage forms.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Neomycin sulfate ophthalmic and topical dosage forms. 524.1484 Section 524.1484 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... NEW ANIMAL DRUGS § 524.1484 Neomycin sulfate ophthalmic and topical dosage forms. ...

21 CFR 524.1044c - Gentamicin sulfate ophthalmic ointment.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Gentamicin sulfate ophthalmic ointment. 524.1044c... § 524.1044c Gentamicin sulfate ophthalmic ointment. (a) Specifications. Each gram of ointment contains gentamicin sulfate equivalent to 3 milligrams of gentamicin. (b) Sponsors. See Nos. 000061 and 043264 in...

21 CFR 524.1044c - Gentamicin sulfate ophthalmic ointment.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Gentamicin sulfate ophthalmic ointment. 524.1044c... § 524.1044c Gentamicin sulfate ophthalmic ointment. (a) Specifications. Each gram of ointment contains gentamicin sulfate equivalent to 3 milligrams of gentamicin. (b) Sponsors. See Nos. 000061 and 025463 in...

21 CFR 524.1484 - Neomycin sulfate ophthalmic and topical dosage forms.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Neomycin sulfate ophthalmic and topical dosage forms. 524.1484 Section 524.1484 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... NEW ANIMAL DRUGS § 524.1484 Neomycin sulfate ophthalmic and topical dosage forms. ...

21 CFR 524.1044c - Gentamicin sulfate ophthalmic ointment.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Gentamicin sulfate ophthalmic ointment. 524.1044c... § 524.1044c Gentamicin sulfate ophthalmic ointment. (a) Specifications. Each gram of ointment contains gentamicin sulfate equivalent to 3 milligrams of gentamicin. (b) Sponsors. See Nos. 000061 and 025463 in...

21 CFR 524.1044 - Gentamicin sulfate ophthalmic and topical dosage forms.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Gentamicin sulfate ophthalmic and topical dosage forms. 524.1044 Section 524.1044 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... NEW ANIMAL DRUGS § 524.1044 Gentamicin sulfate ophthalmic and topical dosage forms. ...

21 CFR 524.1044 - Gentamicin sulfate ophthalmic and topical dosage forms.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Gentamicin sulfate ophthalmic and topical dosage forms. 524.1044 Section 524.1044 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... NEW ANIMAL DRUGS § 524.1044 Gentamicin sulfate ophthalmic and topical dosage forms. ...

21 CFR 524.1044 - Gentamicin sulfate ophthalmic and topical dosage forms.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Gentamicin sulfate ophthalmic and topical dosage forms. 524.1044 Section 524.1044 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... NEW ANIMAL DRUGS § 524.1044 Gentamicin sulfate ophthalmic and topical dosage forms. ...

21 CFR 524.1484 - Neomycin sulfate ophthalmic and topical dosage forms.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Neomycin sulfate ophthalmic and topical dosage forms. 524.1484 Section 524.1484 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... NEW ANIMAL DRUGS § 524.1484 Neomycin sulfate ophthalmic and topical dosage forms. ...

21 CFR 524.1044c - Gentamicin sulfate ophthalmic ointment.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Gentamicin sulfate ophthalmic ointment. 524.1044c... § 524.1044c Gentamicin sulfate ophthalmic ointment. (a) Specifications. Each gram of ointment contains gentamicin sulfate equivalent to 3 milligrams of gentamicin. (b) Sponsors. See Nos. 000061 and 025463 in...

21 CFR 886.1430 - Ophthalmic contact lens radius measuring device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic contact lens radius measuring device... lens radius measuring device. (a) Identification. An ophthalmic contact lens radius measuring device is... lens. (b) Classification. Class I (general controls). The device is exempt from the premarket...

21 CFR 524.1662 - Oxytetracycline hydrochloride ophthalmic and topical dosage forms.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Oxytetracycline hydrochloride ophthalmic and topical dosage forms. 524.1662 Section 524.1662 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... DOSAGE FORM NEW ANIMAL DRUGS § 524.1662 Oxytetracycline hydrochloride ophthalmic and topical dosage forms. ...

21 CFR 524.390a - Chloramphenicol ophthalmic ointment.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Chloramphenicol ophthalmic ointment. 524.390a Section 524.390a Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS...

21 CFR 524.390a - Chloramphenicol ophthalmic ointment.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Chloramphenicol ophthalmic ointment. 524.390a Section 524.390a Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS...

Serum sialic acid levels in patients with sympathetic ophthalmitis.

PubMed

Lamba, P A; Pandey, P K; Sarin, G S; Mathur, M D

1993-12-01

Serum sialic acid levels were measured in 16 patients with sympathetic ophthalmitis, 36 with neglected traumatic uveitis following penetrating injury and 40 healthy subjects. There was no significant alteration of its level in patients with traumatic uveitis. However, its level was significantly elevated in patients with sympathetic ophthalmitis. It was high even in the early stage of the disease. It decreased significantly at the remission stage. It is proposed that measurement of sialic acid level in serum can be used as a diagnostic aid when the diagnosis of sympathetic ophthalmitis remains doubtful on clinical grounds. The extent of rise in its level may be considered a good parameter of the degree of severity of sympathetic ophthalmitis. It may also act as a useful tool to evaluate the drug efficacy in this disease.

Dose uniformity of loteprednol etabonate ophthalmic gel (0.5%) compared with branded and generic prednisolone acetate ophthalmic suspension (1%).

PubMed

Marlowe, Zora T; Davio, Stephen R

2014-01-01

Loteprednol etabonate (LE) ophthalmic gel 0.5% (Lotemax®) is a new polycarbophil-based, nonsettling topical ophthalmic formulation. The formulation is a semisolid gel at rest and a shear thinning fluid when expressed through a dropper tip. The present study was undertaken to determine how the nonsettling character of LE ophthalmic gel affects dose uniformity. Prednisolone acetate ophthalmic suspension 1% (Pred Forte®) and a generic prednisolone acetate suspension 1% were used as comparators. Drug concentrations of LE ophthalmic gel, Pred Forte, and a generic prednisolone acetate suspension were determined following simulated dosing - consisting of 2 drops, expressed four times daily for 2 weeks, with bottles that were shaken or not shaken immediately prior to expressing the drops. Drug concentrations were determined using a reverse-phase high-performance liquid chromatography (HPLC) method and reported as a percentage of the declared (labeled) concentration. Comparative kinetics of drug particle sedimentation were also determined for each formulation, using dispersion analysis under gravity. Mean drug concentrations in drops of all three formulations were within a few percentage points of the declared concentration when the bottles were shaken for 5 seconds prior to dispensing. Only LE ophthalmic gel showed consistent and on-target concentrations when the bottles were unshaken prior to dispensing, with a mean (standard deviation [SD]) percent declared concentration of 102% (1.92%) over the 2-week dosing regimen. Drug concentrations for the branded and generic prednisolone acetate suspensions following expression from unshaken bottles were highly variable (overall relative SDs of 16.8% and 20.3%, respectively), with mean concentrations for both falling significantly below the declared concentration for drops expressed at the beginning of the 2-week dosing regimen and significantly above the declared concentration for drops expressed near the end of the dosing regimen. Dispersion analysis at 120× g showed no drug particle sedimentation for LE ophthalmic gel over the 24-hour testing period, whereas the prednisolone acetate suspensions settled in less than 6 hours. LE ophthalmic gel 0.5% provided consistent dose uniformity at the declared concentration whether or not the bottle was shaken prior to dispensing, whereas Pred Forte® and the generic prednisolone acetate required shaking to provide consistent drug concentrations. LE ophthalmic gel may be beneficial to patients because it eliminates the potential impact on the clinical response of both under- and overdosing.

Corneal anesthesia following application of 0.4% oxybuprocaine hydrochloride ophthalmic solution to normal feline eyes.

PubMed

Giudici, Valentina; Baeza, Sophia; Douet, Jean-Yves; Regnier, Alain

2015-03-01

To evaluate the loss and recovery of corneal sensitivity after instillation of 0.4% oxybuprocaine hydrochloride solution in the normal feline eye. Eighteen European shorthair cats free of ocular disease Baseline corneal touch threshold (CTT) readings were obtained bilaterally with a Cochet-Bonnet aesthesiometer prior to treatment. Subsequently, each cat received a single drop of 0.4% oxybuprocaine ophthalmic solution in the right eye and one drop of sterile 0.9% NaCl in the left eye to serve as control. The corneal touch threshold (CTT) of both eyes was then measured 1 min after drug administration and every 5 min for 60 min. The potential for ocular irritation following oxybuprocaine application was also evaluated. Baseline CTT readings were not significantly different (P > 0.05) between the control and oxybuprocaine-treated eyes with values of 1.75 ± 0.31 cm and 1.75 ± 0.30 cm, respectively. In control eyes, mean CTT did not significantly change (P > 0.05) during the study period. By contrast, after oxybuprocaine application mean CTT was significantly reduced from baseline (P < 0.05) for 45 min. Maximal corneal anesthesia, with a CTT value of 0, was achieved at 1 and 5 min in all treated eyes. A markedly reduced mean CTT of 0.14 ± 0.23 cm was still present at 20 min. Age and gender did not significantly affect corneal anesthesia. No clinically relevant ocular side effects occurred during the observation period. This is the first study that provides objective information on the depth and duration of corneal anesthesia following instillation of oxybuprocaine in healthy feline eyes. © 2014 American College of Veterinary Ophthalmologists.

Clinical and Antiviral Efficacy of an Ophthalmic Formulation of Dexamethasone Povidone-Iodine in a Rabbit Model of Adenoviral Keratoconjunctivitis

PubMed Central

Clement, Christian; Capriotti, Joseph A.; Kumar, Manish; Hobden, Jeffery A.; Foster, Timothy P.; Bhattacharjee, Partha S.; Thompson, Hilary W.; Mahmud, Rashed; Liang, Bo

2011-01-01

Purpose. To determine the efficacy of a new formulation of topical dexamethasone 0.1%/povidone-iodine 0.4% (FST-100) in reducing clinical symptoms and infectious viral titers in a rabbit model of adenoviral keratoconjunctivitis. Methods. Rabbit corneas were inoculated bilaterally with 2 × 106 plaque-forming-units (PFU) of adenovirus type 5 (Ad5) after corneal scarification. Animals were randomized 1:1:1:1 (five rabbits per group) to FST-100, 0.5% cidofovir, tobramycin/dexamethasone (Tobradex; Alcon Laboratories, Fort Worth, TX) ophthalmic suspension, and balanced salt solution (BSS; Alcon Laboratories). Treatment began 12 hours after viral inoculation and continued for 7 consecutive days. The eyes were clinically scored daily for scleral inflammation (injection), ocular neovascularization, eyelid inflammation (redness), friability of vasculature, inflammatory discharge (pus), and epiphora (excessive tearing). Eye swabs were collected daily before treatment for the duration of the study. Virus was eluted from the swabs and PFU determined by titration on human A549 cells, according to standard procedures. Results. The FST-100 treatment resulted in significantly lower clinical scores (P < 0.05) than did the other treatments. The 0.5% cidofovir exhibited the most ocular toxicity compared with FST-100, tobramycin/dexamethasone, and balanced salt solution treatments. FST-100 and 0.5% cidofovir significantly (P < 0.05) reduced viral titers compared with tobramycin/dexamethasone or balanced salt solution. Conclusions. FST-100 was the most efficacious in minimizing the clinical symptoms of adenovirus infection in rabbit eyes. FST-100 and 0.5% cidofovir were both equally effective in reducing viral titers and decreasing the duration of viral shedding. By providing symptomatic relief in addition to reducing infectious virus titers, FST-100 should be a valuable addition to treatment of epidemic adenoviral keratoconjunctivitis. PMID:20702820

21 CFR 886.4570 - Ophthalmic surgical marker.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ophthalmic surgical marker. 886.4570 Section 886.4570 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...) Identification. An ophthalmic surgical marker is a device intended to mark by use of ink, dye, or indentation the...

21 CFR 886.4570 - Ophthalmic surgical marker.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic surgical marker. 886.4570 Section 886.4570 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...) Identification. An ophthalmic surgical marker is a device intended to mark by use of ink, dye, or indentation the...

21 CFR 886.4570 - Ophthalmic surgical marker.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic surgical marker. 886.4570 Section 886.4570 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...) Identification. An ophthalmic surgical marker is a device intended to mark by use of ink, dye, or indentation the...

21 CFR 886.4570 - Ophthalmic surgical marker.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ophthalmic surgical marker. 886.4570 Section 886.4570 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...) Identification. An ophthalmic surgical marker is a device intended to mark by use of ink, dye, or indentation the...

21 CFR 886.4570 - Ophthalmic surgical marker.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic surgical marker. 886.4570 Section 886.4570 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...) Identification. An ophthalmic surgical marker is a device intended to mark by use of ink, dye, or indentation the...

78 FR 77688 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-24

...] Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Ophthalmic Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To... Swink, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave...

The Water-Drinking Test Revisited: An Analysis of Test Results in Subjects with Glaucoma.

PubMed

Razeghinejad, M Reza; Tajbakhsh, Zahra; Nowroozzadeh, M Hossein; Havens, Shane J; Ghate, Deepta; Gulati, Vikas

2018-01-01

The Water-Drinking Test (WDT) has been shown to predict the diurnal IOP change. This study evaluates the factors that may affect the WDT results. This study was conducted on 203 glaucoma patients who had undergone trabeculectomy (53) or tube surgery (31), or had a medically controlled open-angle (82) or closed-angle (37) glaucoma. IOP was measured at baseline and then every 15 minutes over a one-hour period after drinking water. The main outcome measures were IOP change (increase in IOP from baseline) at all measurement time points, IOP peak (highest IOP after drinking water), IOP fluctuation (difference between IOP peak and baseline), and assessing the association of these IOPs with a patient's demographic and management modalities. The mean age of the participants was 54±18 years, and 113 (56%) were male. Female patients showed greater IOP fluctuation than males (7.28 vs. 5.92 mm Hg; P=0.016), and a greater IOP peak (22.7 vs. 20.1 mm Hg; P=0.001). The observed associations between gender and IOP changes were only significant in <50 years. IOP at 60 minutes was greater in tube than trabeculectomy (5.6 vs. 3.1 mm Hg; P=0.007). The number of topical medications showed a direct independent association with IOP changes (P<0.001). Compared to other classes of topical medications, latanoprost showed lower WDT-IOP profile (P=0.0003). WDT-IOP change was diminished in subjects on latanoprost, and was greater in females <50 years, and those on greater number of medications.

Meta-analysis of medical intervention for normal tension glaucoma.

PubMed

Cheng, Jin-Wei; Cai, Ji-Ping; Wei, Rui-Li

2009-07-01

To evaluate the intraocular pressure (IOP) reduction achieved by the most frequently prescribed antiglaucoma drugs in patients with normal tension glaucoma (NTG). Systematic review and meta-analysis. Fifteen randomized clinical trials reported 25 arms for peak IOP reduction, 16 arms for trough IOP reduction, and 13 arms for diurnal curve IOP reduction. Pertinent publications were identified through systematic searches of PubMed, EMBASE, and the Cochrane Controlled Trials Register. The patients had to be diagnosed as having NTG. Methodological quality was assessed by the Delphi list on a scale from 0 to 18. The pooled 1-month IOP-lowering effects were calculated using the 2-step DerSimonian and Laird estimate method of the random effects model. Absolute and relative reductions in IOP from baseline for peak and trough moments. Quality scores of included studies were generally high, with a mean quality score of 12.7 (range, 9-16). Relative IOP reductions were peak, 15% (12%-18%), and trough, 18% (8%-27%) for timolol; peak, 14% (8%-19%), and trough, 12% (-7% to 31%) for dorzolamide; peak, 24% (17%-31%), and trough, 11% (7%-14%) for brimonidine; peak, 20% (17%-24%), and trough, 20% (18%-23%) for latanoprost; peak, 21% (16%-25%), and trough, 18% (14%-22%) for bimatoprost. The differences in absolute IOP reductions between prostaglandin analogues and timolol varied from 0.9 to 1.0 mmHg at peak and -0.1 to 0.2 mmHg at trough. Latanoprost, bimatoprost, and timolol are the most effective IOP-lowering agents in patients with NTG.

Imaging the Effects of Prostaglandin Analogues on Cultured Trabecular Meshwork Cells by Coherent Anti-Stokes Raman Scattering

PubMed Central

Lei, Tim C.; Masihzadeh, Omid; Kahook, Malik Y.; Ammar, David A.

2013-01-01

Purpose. The aim of this study was to nondestructively monitor morphological changes to the lipid membranes of primary cultures of living human trabecular meshwork cells (hTMC) without the application of exogenous label. Methods. Live hTMC were imaged using two nonlinear optical techniques: coherent anti-Stokes Raman scattering (CARS) and two-photon autofluorescence (TPAF). The hTMC were treated with a commercial formulation of latanoprost (0.5 μg/mL) for 24 hours before imaging. Untreated cells and cells treated with vehicle containing the preservative benzalkonium chloride (BAK; 2 μg/mL) were imaged as controls. After CARS/TPAF imaging, hTMC were fixed, stained with the fluorescent lipid dye Nile Red, and imaged by conventional confocal microscopy to verify lipid membrane structures. Results. Analysis of CARS/TPAF images of hTMC treated with latanoprost revealed multiple intracellular lipid membranes absent from untreated or BAK-treated hTMC. Treatment of hTMC with sodium fluoride or ouabain, agents shown to cause morphological changes to hTMC, also did not induce formation of intracellular lipid membranes. Conclusions. CARS microscopy detected changes in living hTMC morphology that were validated by subsequent histological stain. Prostaglandin-induced changes to hTMC involved rearrangement of lipid membranes within these cells. These in vitro results identify a novel biological response to a class of antiglaucoma drugs, and further experiments are needed to establish how this effect is involved in the hypotensive action of prostaglandin analogues in vivo. PMID:23900606

Microbead-induced ocular hypertensive mouse model for screening and testing of aqueous production suppressants for glaucoma.

PubMed

Yang, Qiang; Cho, Kin-Sang; Chen, Huihui; Yu, Dekuang; Wang, Wan-Heng; Luo, Gang; Pang, Iok-Hou; Guo, Wenyi; Chen, Dong Feng

2012-06-20

To characterize the microbead-induced ocular hypertension (OHT) mouse model and investigate its potential use for preclinical screening and evaluation of ocular hypotensive agents, we tested the model's responses to major antiglaucoma drugs. Adult C57BL/6J mice were induced to develop OHT unilaterally by intracameral injection of microbeads. The effects of the most commonly used ocular hypotensive drugs, including timolol, brimonidine, brinzolamide, pilocarpine, and latanoprost, on IOP and glaucomatous neural damage were evaluated. Degeneration of retinal ganglion cells (RGCs) and optic nerve axons were quantitatively assessed using immunofluorescence labeling and histochemistry. Thickness of the ganglion cell complex (GCC) was also assessed with spectral-domain optical coherence tomography (SD-OCT). A microbead-induced OHT model promptly responded to drugs, such as timolol, brimonidine, and brinzolamide, that lower IOP through suppressing aqueous humor production and showed improved RGC and axon survival as compared to vehicle controls. Accordingly, SD-OCT detected significantly less reduction of GCC thickness in mice treated with all three aqueous production suppressants as compared to the vehicle contol-treated group. In contrast, drugs that increase aqueous outflow, such as pilocarpine and latanoprost, failed to decrease IOP in the microbead-induced OHT mice. Microbead-induced OHT mice carry dysfunctional aqueous outflow facility and therefore offer a unique model that allows selective screening of aqueous production suppressant antiglaucoma drugs or for studying the mechanisms regulating aqueous humor production. Our data set the stage for using GCC thickness assessed by SD-OCT as an imaging biomarker for noninvasive tracking of neuronal benefits of glaucoma therapy in this model.

A temperature-induced and shear-reversible assembly of latanoprost-loaded amphiphilic chitosan colloids: characterization and in vivo glaucoma treatment.

PubMed

Hsiao, Meng-Hsuan; Chiou, Shih-Hwa; Larsson, Mikael; Hung, Kuo-Hsuan; Wang, Yi-Ling; Liu, Catherine Jui-Ling; Liu, Dean-Mo

2014-07-01

Hydrogels composed of assembled colloids is a material class that is currently receiving much interest and shows great promise for use in biomedical applications. This emerging material class presents unique properties derived from the combination of nanosized domains in the form of colloidal particles with a continuous gel network and an interspersed liquid phase. Here we developed an amphiphilic chitosan-based, thermogelling, shear-reversible colloidal gel system for improved glaucoma treatment and addressed how preparation procedures and loading with the anti-glaucoma drug latanoprost and commonly used preservative benzalkonium chloride influenced the mechanical properties of and drug release from the colloidal gels. The results highlight that incorporated substances and preparation procedures have effects both on mechanical properties and drug release, but that the release of drug loaded in the colloidal carriers is mainly limited by transport out of the carriers, rather than by diffusion within the gel. The developed colloidal chitosan based gels hold outstanding biomedical potential, as confirmed by the ease of preparation and administration, low cytotoxicity in MTT assay, excellent biocompatibility and lowering of intraocular pressure for 40 days in a rabbit glaucoma model. The findings clearly justify further investigations towards clinical use in the treatment of glaucoma. Furthermore, the use of this shear-reversible colloidal gel could easily be extended to localized treatment of a number of critical conditions, from chronic disorders to cancer, potentially resulting in a number of new therapeutics with improved clinical performance. Copyright © 2014 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.

Assessing blood vessel perfusion and vital signs through retinal imaging photoplethysmography.

PubMed

Hassan, Harnani; Jaidka, Sheila; Dwyer, Vincent M; Hu, Sijung

2018-05-01

One solution to the global challenge of increasing ocular disease is a cost-effective technique for rapid screening and assessment. Current ophthalmic imaging techniques, e.g. scanning and ocular blood flow systems, are expensive, complex to operate and utilize invasive contrast agents during assessment. The work presented here demonstrates a simple retinal imaging photoplethysmography (iPPG) system with the potential to provide screening, diagnosis, monitoring and assessment that is non-invasive, painless and radiationless. Time series of individual retinal blood vessel images, captured with an eye fundus camera, are processed using standard filtering, amplitude demodulation and principle component analysis (PCA) methods to determine the values of the heart rate (HR) and respiration rate (RR), which are in compliance with simultaneously obtained measurements using commercial pulse oximetry. It also seems possible that some information on the dynamic changes in oxygen saturation levels ( SpO 2 ) in a retinal blood vessel may also be obtained. As a consequence, the retinal iPPG modality system demonstrates a potential avenue for rapid ophthalmic screening, and even early diagnosis, against ocular disease without the need for fluorescent or contrast agents.

75 FR 35495 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-22

...] Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Ophthalmic Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To... Glaukos iStent Trabecular Micro-Bypass Stent, Model GTS-100 L/R, sponsored by Glaukos Corp. The device is...

10 CFR 35.433 - Decay of strontium-90 sources for ophthalmic treatments.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Decay of strontium-90 sources for ophthalmic treatments... Brachytherapy § 35.433 Decay of strontium-90 sources for ophthalmic treatments. (a) Only an authorized medical physicist shall calculate the activity of each strontium-90 source that is used to determine the treatment...

10 CFR 35.433 - Decay of strontium-90 sources for ophthalmic treatments.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Decay of strontium-90 sources for ophthalmic treatments... Brachytherapy § 35.433 Decay of strontium-90 sources for ophthalmic treatments. (a) Only an authorized medical physicist shall calculate the activity of each strontium-90 source that is used to determine the treatment...

10 CFR 35.433 - Decay of strontium-90 sources for ophthalmic treatments.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Decay of strontium-90 sources for ophthalmic treatments... Brachytherapy § 35.433 Decay of strontium-90 sources for ophthalmic treatments. (a) Only an authorized medical physicist shall calculate the activity of each strontium-90 source that is used to determine the treatment...

10 CFR 35.433 - Decay of strontium-90 sources for ophthalmic treatments.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false Decay of strontium-90 sources for ophthalmic treatments... Brachytherapy § 35.433 Decay of strontium-90 sources for ophthalmic treatments. (a) Only an authorized medical physicist shall calculate the activity of each strontium-90 source that is used to determine the treatment...

10 CFR 35.433 - Decay of strontium-90 sources for ophthalmic treatments.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false Decay of strontium-90 sources for ophthalmic treatments... Brachytherapy § 35.433 Decay of strontium-90 sources for ophthalmic treatments. (a) Only an authorized medical physicist shall calculate the activity of each strontium-90 source that is used to determine the treatment...

validated microbiological and HPLC methods for the determination of moxifloxacin in pharmaceutical preparations and human plasma.

PubMed

Abdelaziz, Ahmed A; Elbanna, Tarek E; Gamaleldeen, Noha M

2012-10-01

The article presents a comparison between microbiological and high performance liquid chromatographic (HPLC) assays for quantification of moxifloxacin in tablets, ophthalmic solutions and human plasma. The microbiological method employed a cylinder-plate agar diffusion assay using a strain of Esherichia coli ATCC 25922 as the test organism and phosphate buffer (pH8) as the diluent. The calibration curves were linear (R(2) > 0.98) over a concentration range of 0.125 to 16 µgml(-1). The within day and between days precisions were ≤ 4.47% and ≤ 6.39% respectively. Recovery values were between 89.4 and 110.2%. The HPLC assay used Hypersil(®) BDS C18 reversed phase column (250×4.6 mm, 5µm) with a mobile phase comprising 20 mM ammonium dihydrogen orthophosphate (pH3) and acetonitrile (75:25) and flowing at 1.5 ml/min. The detection was at 295nm. The calibration curves were linear (R(2) > 0.999) over the range of 0.125 to 16 µg ml(-1). The within day and between days precisions were ≤ 4.07% and ≤ 5.09% respectively. Recovery values were between 97.7 and 107.6%. Similar potencies were obtained after the analysis of moxifloxacin tablets and ophthalmic solutions by both methods. Also pharmacokinetic parameters were calculated after the analysis of plasma samples of six male healthhy volunteers by both validated methods.

Multidose Preservative Free Eyedrops by Selective Removal of Benzalkonium Chloride from Ocular Formulations.

PubMed

Hsu, Kuan-Hui; Gupta, Karishma; Nayaka, Harish; Donthi, Aashrit; Kaul, Siddarth; Chauhan, Anuj

2017-12-01

About 70% of eye drops contain benzalkonium chloride (BAK) to maintain sterility. BAK is an effective preservative but it can cause irritation and toxicity. We propose to mitigate ocular toxicity without compromising sterility by incorporating a filter into an eye drop bottle to selectively remove BAK during the process of drop instillation. The filter is a packed bed of particles made from poly(2-hydroxyethyl methacrylate) (pHEMA), which is a common ophthalmic material. We showed that pHEMA particle prepared by using ethoxylated trimethylolpropane triacrylate as crosslinker can be incorporated into a modified eyedrop bottle tip to selectively remove the preservative as the formulation is squeezed out of the bottle. Hydraulic permeability of the plug is measured to determine the resistance to eye drop squeezing, and % removal of BAK and drugs are determined. The modified tip has a hydraulic permeability of about 2 Darcy, which allows eyedrops formulations to flow through without excessive resistance. The tip is designed such that the patients can create an eyedrop of solution of 1-10 cP viscosity in 4 s with a nominal pressure. During this short contact time, the packed particles removed nearly 100% of benzalkonium chloride (BAK) from a 15 mL, 0.012% BAK solution but have only minimal impact on the concentration of contained active components. Our novel design can eliminate the preservative induced toxicity from eye drops thereby impacting hundreds of millions of patients with chronic ophthalmic diseases like glaucoma and dry eyes.

A comparison of Fluoracaine and Fluorox on corneal epithelial cell desquamation after Goldmann Applanation Tonometry.

PubMed

Yeung, K K; Kageyama, J Y; Carnevali, T

2000-01-01

The purpose of this study was to quality the frequency and amount of corneal desquamation from a sodium fluorescein/proparacaine combination (Fluoracaine) as compared with sodium fluorescein/benoxinate combination ophthalmic solution (Fluorox) after Goldmann Applanation Tonometry. One drop of Fluoracaine was randomly instilled into one eye and one drop of Fluorox was instilled into the opposite eye of the same patient. Intraocular pressures (IOPs) by GAT and tear break-up times (TBUTs) were taken. Corneal stinging was compared. Corneal integrity by Cornea and Contact Lens Research Unit (CCLRU) standards was evaluated at 0, 3, 7, 10, 15, and 20 minutes after instillation of the ophthalmic solutions. Sixty eyes of 30 patients were observed Forty-seven percent of the patients reported Fluorox to string more than Fluoracaine; 23% of the patients reported that Fluoracaine stings more than Fluorox; and 30% the patients reported no difference. Average TBUTs were 6.87 and 7.17 seconds with Fluoracaine and Fluorox, respectively. Fluoracaine produced micro- and macropunctate keratitis of the superficial epithelium in 31% to 45% of the cornea. Fluorox caused superficial micropunctate keratitis in about 16% to 30% of the cornea. At 20 minutes, all eyes with Fluoracaine and all eyes but one with Fluorox had corneal desquamation. Fluoracaine causes marginally less stinging--however, clinically and statistically more corneal desquamation--than Fluorox after GAT. Corneal integrity after use of Fluoracaine should be evaluated even 20 minutes after GAT procedures for corneal disruption.

METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS INFECTIONS OF THE EYE AND ORBIT (AN AMERICAN OPHTHALMOLOGICAL SOCIETY THESIS)

PubMed Central

Blomquist, Preston Howard

2006-01-01

Purpose To ascertain if methicillin-resistant Staphyloccocus aureus (MRSA) ophthalmic infections are increasing. Methods A retrospective review of all patients with a culture positive for MRSA in the Parkland Health and Hospital System, the urban public healthcare system for Dallas County, Texas, for the years 2000 through 2004 was performed. Patients with ocular, orbital, and ocular adnexal infection were identified, and isolates were categorized as nosocomial or community-acquired (CA). Results A total of 3,640 patients with a culture positive for MRSA were identified, with 1,088 patients (30%) considered to have acquired the isolate via nosocomial transmission and 2,552 patients (70%) considered to have CA-MRSA. Forty-nine patients (1.3%) had ophthalmic MRSA involvement. For both ophthalmic and nonophthalmic cases, the number of CA-MRSA patients increased each year, whereas the numbers of nosocomial patients remained fairly constant. Patients with ophthalmic MRSA tended to be younger than other MRSA patients (P = .023). The most common manifestation of ophthalmic MRSA infection was preseptal cellulitis and/or lid abscess followed by conjunctivitis, but sight-threatening infections, including corneal ulcers, endophthalmitis, orbital cellulitis, and blebitis, also occurred. Empirical antibiotic coverage was initially prescribed in 48 (98%) of ophthalmic cases and did not adequately cover for the MRSA isolate in 24 (50%). Conclusions CA-MRSA is becoming increasingly prevalent, and ophthalmologists will see more ophthalmic MRSA infections. Although ophthalmic CA-MRSA commonly presents as preseptal lid infection and conjunctivitis, sight-threatening infections also occur. Ophthalmologists must identify MRSA patients, adjust empirical treatment regimens where MRSA is endemic, and take steps to control emergence of resistant organisms in both inpatient and outpatient practices. PMID:17471350

Iatrogenic occlusion of the ophthalmic artery after cosmetic facial filler injections: a national survey by the Korean Retina Society.

PubMed

Park, Kyu Hyung; Kim, Yong-Kyu; Woo, Se Joon; Kang, Se Woong; Lee, Won Ki; Choi, Kyung Seek; Kwak, Hyung Woo; Yoon, Ill Han; Huh, Kuhl; Kim, Jong Woo

2014-06-01

Iatrogenic occlusion of the ophthalmic artery and its branches is a rare but devastating complication of cosmetic facial filler injections. To investigate clinical and angiographic features of iatrogenic occlusion of the ophthalmic artery and its branches caused by cosmetic facial filler injections. Data from 44 patients with occlusion of the ophthalmic artery and its branches after cosmetic facial filler injections were obtained retrospectively from a national survey completed by members of the Korean Retina Society from 27 retinal centers. Clinical features were compared between patients grouped by angiographic findings and injected filler material. Visual prognosis and its relationship to angiographic findings and injected filler material. Ophthalmic artery occlusion was classified into 6 types according to angiographic findings. Twenty-eight patients had diffuse retinal and choroidal artery occlusions (ophthalmic artery occlusion, generalized posterior ciliary artery occlusion, and central retinal artery occlusion). Sixteen patients had localized occlusions (localized posterior ciliary artery occlusion, branch retinal artery occlusion, and posterior ischemic optic neuropathy). Patients with diffuse occlusions showed worse initial and final visual acuity and less visual gain compared with those having localized occlusions. Patients receiving autologous fat injections (n = 22) had diffuse ophthalmic artery occlusions, worse visual prognosis, and a higher incidence of combined brain infarction compared with patients having hyaluronic acid injections (n = 13). Clinical features of iatrogenic occlusion of the ophthalmic artery and its branches following cosmetic facial filler injections were diverse according to the location and extent of obstruction and the injected filler material. Autologous fat injections were associated with a worse visual prognosis and a higher incidence of combined cerebral infarction. Extreme caution and care should be taken during these injections, and physicians should be aware of a diverse spectrum of complications following cosmetic facial filler injections.

EyeMIAS: a cloud-based ophthalmic image reading and auxiliary diagnosis system

NASA Astrophysics Data System (ADS)

Wu, Di; Zhao, Heming; Yu, Kai; Chen, Xinjian

2018-03-01

Relying solely on ophthalmic equipment is unable to meet the present health needs. It is urgent to find an efficient way to provide a quick screening and early diagnosis on diabetic retinopathy and other ophthalmic diseases. The purpose of this study is to develop a cloud-base system for medical image especially ophthalmic image to store, view and process and accelerate the screening and diagnosis. In this purpose the system with web application, upload client, storage dependency and algorithm support is implemented. After five alpha tests, the system bore the thousands of large traffic access and generated hundreds of reports with diagnosis.

Ophthalmic community perception of new medication needs.

PubMed

Stewart, William C; Stewart, Jeanette A; Nelson, Lindsay A

2018-01-01

To survey ophthalmologists (who have participated previously in clinical research) and ophthalmic industry professionals (who have been involved in ocular research and development) to indicate perceived needs for new pharmaceuticals in various ophthalmic subspecialties. A prospective, industry-based survey was sent to ophthalmologists and ophthalmic industry professionals about the perceived needs for new pharmaceutical products. This survey was sent to 559 ophthalmic pharma professionals and ophthalmologists. We received 82 (15%) responses. The results showed that the most commonly perceived need for new pharmaceuticals were dry and wet age-related macular degeneration, glaucoma, diabetic macular edema and dry eye. There was a statistical difference found between response groups ( P <0.0001). Respondents indicated they would express their commitment to a new product they perceived as needed by recommending to colleagues (63%), prescribing (60%), participating as principle investigator in a related clinical trial (52%), advising the company (52%), lecturing on behalf of the product (43%), investing in the product (38%), taking no action (7%) or obtain a position in the company (1%). Ophthalmic pharma professionals and ophthalmologists perceive the greatest need for new medicines in ophthalmology to be in dry and wet age-related macular degeneration, glaucoma, diabetic macular edema and dry eye.

Serum beta-2 microglobulin level in sympathetic ophthalmitis.

PubMed

Sen, D K; Sarin, G S; Mathur, M D

1990-04-01

Serum beta-2 microglobulin (beta 2-m) levels were measured in 12 patients with sympathetic ophthalmitis, 34 with neglected traumatic uveitis following penetrating injury and 36 healthy subjects by ELISA technique. There was no significant alteration of its level in patients with traumatic uveitis. However, its levels were significantly increased in patients with sympathetic ophthalmitis. They were high even in the early stage of the disease. Serum beta 2-m levels paralleled the severity of disease. It decreased significantly at the remission stage. Four patients came back with relapse of the condition and the level of serum beta 2-m was again found to be elevated in them. It is proposed that estimation of beta 2-m can be used as a diagnostic aid when the diagnosis of sympathetic ophthalmitis remains doubtful on clinical grounds. It is also suggested that a rise in serum beta 2-m in patients with traumatic uveitis following perforating injuries may point to the onset of sympathetic ophthalmitis. The extent of rise in its level may be considered a good parameter of the degree of severity of sympathetic ophthalmitis. It may also act as a useful tool to evaluate the drug efficacy in this disease and predict relapse.

[Medical Studies + Internship + Vocational Training = A Complete Ophthalmic Surgeon? A Theoretical Analysis of the Ophthalmic Surgery Training from the Perspective of Medical and Educational Sciences].

PubMed

Köffler, N M; Kastl, G

2017-02-01

"Let's have the courage to train young doctors to conduct ophthalmic surgery!" - This is the final plea of this theoretical article, which appeals for greater collaboration between medical and educational sciences in the training of ophthalmic surgeons. It will be discussed whether surgery-based training is adequate, from the point of view of both medical knowledge and learning theory. Standard requirements for the specialist qualification in ophthalmic surgery are presented for Bavaria, Austria and Switzerland; these are then compared and contrasted with the experience-based practice of vocational training. Assuming that vocational training can be understood as providing the context for action-oriented learning, the relevance of procedural knowledge will be discussed for the development of practical surgical skills. A model for expertise in ophthalmic surgery will be outlined. Instructors' didactic skills and expertise will be discussed in relation to the requirements and guidelines for receiving the license to train assistants. In general, the article highlights the relevance of performance in learning surgery, and calls for the provision of sufficient possibilities to learn surgery in the course of assistant doctors' vocational training. This article addresses those who are involved in ophthalmologists' and ophthalmic surgeons' vocational training (e.g. medical instructors, medical associations, assistant doctors) and who welcome thought-provoking impulses from unfamiliar academic disciplines on key questions and concerns in practical vocational training. Georg Thieme Verlag KG Stuttgart · New York.

10 CFR 35.2433 - Records of decay of strontium-90 sources for ophthalmic treatments.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Records of decay of strontium-90 sources for ophthalmic... Records § 35.2433 Records of decay of strontium-90 sources for ophthalmic treatments. (a) A licensee shall maintain a record of the activity of a strontium-90 source required by § 35.433 for the life of the source...

10 CFR 35.2433 - Records of decay of strontium-90 sources for ophthalmic treatments.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false Records of decay of strontium-90 sources for ophthalmic... Records § 35.2433 Records of decay of strontium-90 sources for ophthalmic treatments. (a) A licensee shall maintain a record of the activity of a strontium-90 source required by § 35.433 for the life of the source...

10 CFR 35.2433 - Records of decay of strontium-90 sources for ophthalmic treatments.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Records of decay of strontium-90 sources for ophthalmic... Records § 35.2433 Records of decay of strontium-90 sources for ophthalmic treatments. (a) A licensee shall maintain a record of the activity of a strontium-90 source required by § 35.433 for the life of the source...

10 CFR 35.2433 - Records of decay of strontium-90 sources for ophthalmic treatments.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false Records of decay of strontium-90 sources for ophthalmic... Records § 35.2433 Records of decay of strontium-90 sources for ophthalmic treatments. (a) A licensee shall maintain a record of the activity of a strontium-90 source required by § 35.433 for the life of the source...

10 CFR 35.2433 - Records of decay of strontium-90 sources for ophthalmic treatments.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Records of decay of strontium-90 sources for ophthalmic... Records § 35.2433 Records of decay of strontium-90 sources for ophthalmic treatments. (a) A licensee shall maintain a record of the activity of a strontium-90 source required by § 35.433 for the life of the source...

Smart ophthalmics: the future in tele-ophthalmology has arrived

NASA Astrophysics Data System (ADS)

Fink, Wolfgang; Tarbell, Mark A.; Garcia, Kevin

2016-05-01

Smart Ophthalmics© extends ophthalmic healthcare to people who operate/live in austere environments (e.g., military, third world, natural disaster), or are geographically dispersed (e.g., rural populations), where time, cost, and the possibility of travel/transportation make access to even adequate medical care difficult, if at all possible. Operators attach optical devices that act as ophthalmic examination extensions to smartphones and run custom apps to perform examinations of specific areas of the eye. The smartphone apps submit over wireless networks the collected examination data to a smart remote expert system, which provides in-depth medical analyses that are sent back in near real-time to the operators for subsequent triage.

Updates in ophthalmic pathology.

PubMed

Mendoza, Pia R; Grossniklaus, Hans E

2017-05-01

Ophthalmic pathology has a long history and rich heritage in the field of ophthalmology. This review article highlights updates in ophthalmic pathology that have developed significantly through the years because of the efforts of committed individuals and the confluence of technology such as molecular biology and digital pathology. This is an exciting period in the history of ocular pathology, with cutting-edge techniques paving the way for new developments in diagnostics, therapeutics, and research. Collaborations between ocular oncologists and pathologists allow for improved and comprehensive patient care. Ophthalmic pathology continues to be a relevant specialty that is important in the understanding and clinical management of ocular disease, education of eye care providers, and overall advancement of the field.

Recent advances in developing ophthalmic formulations: a patent review.

PubMed

Lu, Guang Wei

2010-01-01

In an effort to improve the drug solubility, stability and/or ocular bioavailability of ophthalmic formulations,various approaches have been explored in the recent past. Additionally, different formulations have been investigated in order to seek those preservative systems that are more tolerable to the ocular tissue. Over the past ten years, inventions in ophthalmic formulations directed toward front-of-eye instillations have concentrated in the areas of new excipients' applications, novel and combined use of conventional excipients, and developments of novel dosage forms. Among these areas, applications of polymeric excipients, cyclodextrins and stabilized chloride dioxide (SCD) have been the most actively studied fields. In addition, oil-in-water (O/W) emulsions have been becoming more popular as an ophthalmic dosage form due to the potentials in increasing drug solubility, stabilizing active pharmaceutical ingredients (APIs), improving ocular tolerance, and providing palliative effects. Some of these innovations from the past decade have the capability of leading to new commercial products. This patent review has a useful knowledge in the advancement for treating various ophthalmic diseases.

Evaluation and Referral of Diabetic Eye Disease in the Endocrinology and Primary Care Office Settings.

PubMed

Silva, Fabiana Q; Adhi, Mehreen; Wai, Karen M; Olansky, Leann; Lansang, M Cecilia; Singh, Rishi P

2016-10-01

The purpose of this study was to identify whether endocrinologists and primary care physicians (PCP) adequately screen for ophthalmic symptoms/signs within office visits and provide timely ophthalmology referrals in patients with diabetes. Patients between the ages of 18 years and 80 years with diabetes who underwent an office visit with an endocrinologist or a PCP between January 1, 2014, and December 31, 2014, were identified. Demographics, ophthalmic assessments, and referral information were collected. A total of 1,250 patient records were reviewed. Providers asked about ophthalmic symptoms/signs in 95.5% and 71% of endocrinology and primary care office encounters, respectively (P < .0001). Past and/or future ophthalmology appointments were verified in 86.1% and 49.7% of patients during endocrinology and PCP visits, respectively (P < .0001). Ophthalmic complications from diabetes are not adequately screened, especially within the primary care setting, and further quality improvement measures may improve adherence to recommended screening protocols. [Ophthalmic Surg Lasers Imaging Retina. 2016;47:930-934.]. Copyright 2016, SLACK Incorporated.

Enhancement of scleral macromolecular permeability with prostaglandins.

PubMed Central

Weinreb, R N

2001-01-01

PURPOSE: It is proposed that the sclera is a metabolically active and pharmacologically responsive tissue. These studies were undertaken to determine whether prostaglandin exposure can enhance scleral permeability to high-molecular-weight substances. METHODS: Topical prostaglandin F2 alpha (PGF2 alpha) was administered to monkeys to determine if this altered the amount of scleral matrix metalloproteinases (MMPs). Experiments also were performed to determine whether the prostaglandin F (FP) receptor and gene transcripts are expressed in normal human sclera. Permeability of organ-cultured human sclera following prostaglandin exposure then was studied and the amount of MMP released into the medium measured. Finally, the permeability of human sclera to basic fibroblast growth factor (FGF-2) was determined following prostaglandin exposure. RESULTS: Topical prostaglandin administration that reduced scleral collagen also increased scleral MMP-1, MMP-2, and MMP-3 by 63 +/- 35%, 267 +/- 210%, and 729 +/- 500%, respectively. FP receptor protein was localized in scleral fibroblasts, and FP receptor gene transcript was identified in sclera. Exposure to prostaglandin F2 alpha, 17-phenyltrinor, PGF2 alpha, or latanoprost acid increased scleral permeability by up to 124%, 183%, or 213%, respectively. In these cultures, MMP-1, MMP-2, and MMP-3 were increased by up to 37%, 267%, and 96%, respectively. Finally, transscleral absorption of FGF-2 was increased by up to 126% with scleral exposure to latanoprost. CONCLUSIONS: These studies demonstrate that the sclera is metabolically active and pharmacologically responsive to prostaglandins. Further, they demonstrate the feasibility of cotreatment with prostaglandin to enhance transscleral delivery of peptides, such as growth factors and high-molecular-weight substances, to the posterior segment of the eye. PMID:11797317

Facilitating the quality of care in a specialist Pacific ophthalmic nursing workforce.

PubMed

du Toit, R; Hughes, F; Mason, I; Tousignant, B

2011-03-01

Sufficient, appropriately trained health personnel need to be retained in the workforce, and their performance maintained, to achieve quality care. Mid-level ophthalmic personnel in Western Pacific Island Countries and Territories (WPICT) are no exception. The study aims to assess influences on the quality of care provided by specialist mid-level ophthalmic personnel in WPICT and devise strategies to train, retain and maintain performance of these personnel. A situational assessment employed a checklist and semi-structured interviews with specialist mid-level ophthalmic personnel, nursing bodies and Ministry of Health representatives from seven WPICT. A selective literature review guided strategies to address the issues identified. Appropriate training allows nurses to fulfill a mid-level role in WPICT as specialist ophthalmic nurses. Resources generally do not restrict practice. Nursing structures have generally failed to support professionalism: scope and conditions of service, clinical supervision, career structures, professional recognition and opportunities for continuing professional development are rudimentary. Ophthalmic nurses were dissatisfied with the lack of specialty recognition, career progression and salary increase. Regional and local strategies tailored to each country have been devised to establish sustainable processes for support. Salary was a major cause of dissatisfaction. It should be addressed along with professional recognition and related processes. Without professional support, specialist and advanced cadres within nursing may cease to exist, nurses' performance may be affected or they may leave. Specialist ophthalmic nursing, recognized, situated within and properly supported by nursing structures can provide a model for specialist clinical care for other specialties and in other countries. © 2010 The Authors. International Nursing Review © 2010 International Council of Nurses.

Ophthalmic presentation of giant cell arteritis in African-Americans

PubMed Central

Garrity, S T; Pistilli, M; Vaphiades, M S; Richards, N Q; Subramanian, P S; Rosa, P R; Lam, B L; Osborne, B J; Liu, G T; Duncan, K E; Shin, R K; Volpe, N J; Shindler, K S; Lee, M S; Moster, M L; Tracey, E H; Cuprill-Nilson, S E; Tamhankar, M A

2017-01-01

Purpose To determine the differences in the presentation of ophthalmic giant cell arteritis between African-Americans and Caucasians. Methods This was a multicenter retrospective case series comparing African-American patients with ophthalmic GCA to a previously published Caucasian cohort. Neuro-ophthalmic centers across the United States were contacted to provide data on African-American patients with biopsy-proven ophthalmic giant cell arteritis. The differences between African-American and Caucasian patients with respect to multiple variables, including age, sex, systemic and ophthalmic signs and symptoms, ocular ischemic lesions, and laboratory results were studied. Results The Caucasian cohort was slightly older (mean=76.1 years) than the African-American cohort (mean=72.6 years, P=0.03), and there was no difference in sex distribution between the two cohorts. Headache, neck pain, and anemia were more frequent, while jaw claudication was less frequent in African-Americans (P<0.01, <0.001, 0.02, and 0.03 respectively). Acute vision loss was the most common presentation of giant cell arteritis in both groups, though it was less common in African-Americans (78 vs 98% of Caucasians, P<0.001). Eye pain was more common in African-Americans (28 vs 8% of Caucasians, P<0.01). Conclusions The presenting features of ophthalmic giant cell arteritis in African-Americans and Caucasians are not markedly different, although a few significant differences exist, including higher rates of headache, neck pain, anemia, and eye pain, and lower rates of jaw claudication and acute vision loss in African-Americans. Persons presenting with suspicious signs and symptoms should undergo evaluation for giant cell arteritis regardless of race. PMID:27636230

SOCIETAL COSTS ASSOCIATED WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION IN THE UNITED STATES.

PubMed

Brown, Melissa M; Brown, Gary C; Lieske, Heidi B; Tran, Irwin; Turpcu, Adam; Colman, Shoshana

2016-02-01

The purpose of this study was to use a cross-sectional prevalence-based health care economic survey to ascertain the annual, incremental, societal ophthalmic costs associated with neovascular age-related macular degeneration. Consecutive patients (n = 200) with neovascular age-related macular degeneration were studied. A Control Cohort included patients with good (20/20-20/25) vision, while Study Cohort vision levels included Subcohort 1: 20/30 to 20/50, Subcohort 2: 20/60 to 20/100, Subcohort 3: 20/200 to 20/400, and Subcohort 4: 20/800 to no light perception. An interviewer-administered, standardized, written survey assessed 1) direct ophthalmic medical, 2) direct nonophthalmic medical, 3) direct nonmedical, and 4) indirect medical costs accrued due solely to neovascular age-related macular degeneration. The mean annual societal cost for the Control Cohort was $6,116 and for the Study Cohort averaged $39,910 (P < 0.001). Study Subcohort 1 costs averaged $20,339, while Subcohort 4 costs averaged $82,984. Direct ophthalmic medical costs comprised 17.9% of Study Cohort societal ophthalmic costs, versus 74.1% of Control Cohort societal ophthalmic costs (P < 0.001) and 10.4% of 20/800 to no light perception subcohort costs. Direct nonmedical costs, primarily caregiver, comprised 67.1% of Study Cohort societal ophthalmic costs, versus 21.3% ($1,302/$6,116) of Control Cohort costs (P < 0.001) and 74.1% of 20/800 to no light perception subcohort costs. Total societal ophthalmic costs associated with neovascular age-related macular degeneration dramatically increase as vision in the better-seeing eye decreases.

Rapid detection of bacterial endotoxins in ophthalmic viscosurgical device materials by direct analysis in real time mass spectrometry.

PubMed

Li, Hongli; Hitchins, Victoria M; Wickramasekara, Samanthi

2016-11-02

Bacterial endotoxins are lipopolysaccharides bound to the bacterial cell wall and released when bacteria rupture or disintegrate. Possible contamination of endotoxin in ophthalmic devices can cause a painful eye inflammation or result in toxic anterior segment syndrome after cataract surgery. Measurement of bacterial endotoxin in medical device materials is difficult since endotoxin binds with polymer matrix and some of the materials are very viscous and non-water soluble, where traditional enzyme-based Limulus amebocyte lysate (LAL) assay cannot be applied. Here we propose a rapid and high throughput ambient ionization mass spectrometric (MS) method using direct analysis in real time (DART) for the evaluation of endotoxin contamination in medical device materials. Large and structurally complex endotoxin instantaneously breaks down into low-mass characteristic fragment ions using DART and is detected by MS in both positive and negative ion modes. This method enables the identification and separation of endotoxin from medical materials with a detection limit of 0.03 ng mL -1 endotoxins in aqueous solution. Ophthalmic viscosurgical device materials including sodium hyaluronate (NaHA), non-water soluble perfluoro-n-octane (PFO) and silicone oil (SO) were spiked with different known concentrations of endotoxin and analyzed by DART MS, where the presence of endotoxin was successfully detected and featured small mass fragment ions were generated for NaHA, PFO and SO as well. Current findings showed the feasibility of measuring endotoxin contamination in medical device materials using DART-MS, which can lead to a one-step analysis of endotoxins in different matrices, avoiding any potential contamination during sample pre-treatment steps. Published by Elsevier B.V.

Dacryocystitis following a nasolacrimal duct obstruction caused by an ectopic intranasal tooth in a dog.

PubMed

Voelter-Ratson, Katrin; Hagen, Regine; Grundmann, Stefan; Spiess, Bernhard Martin

2015-09-01

To describe a nasolacrimal duct (NLD) obstruction secondary to an ectopic tooth in a 5-year-old male Border collie. The dog was presented with a 1-month history of mucopurulent discharge from the left eye (OS) preceded by a lifelong history of epiphora OS. Treatment with neomycin/polymyxin B/dexamethasone ophthalmic solution had not improved the clinical signs, and the NLD was not patent when irrigated by the referring veterinarian. A complete ophthalmologic examination was performed followed by dacryocystorhinography and computed tomography (CT). The ophthalmologic examination revealed marked mucopurulent discharge, mild conjunctivitis, slightly elevated STT measurements, and a negative Jones test OS. Both nasolacrimal puncta OS could be cannulated without resistance for approximately 1.5 cm. Upon irrigation, copious amounts of mucopurulent discharge were exited through the corresponding punctum, while no fluid could be detected at the nares. Dacryocystorhinography was performed. Radiographs revealed an ectopic left canine tooth within the left nasal cavity. A cystic dilation of the NLD was observed proximal to the ectopic tooth. Computed tomography was performed to determine the exact position of the tooth and possible involvement of adjacent structures; CT confirmed the previous imaging findings. Treatment with systemic antibiotics, NSAIDs, and ofloxacin ophthalmic solution led to resolution of the clinical signs within several days. Surgery was declined by the owner. This is the first case report describing a blocked NLD due to an ectopic tooth in a dog. Ectopic teeth should be included as a differential diagnosis in cases of dacryocystitis and chronic epiphora in dogs. © 2014 American College of Veterinary Ophthalmologists.

Effect of topical 3% diquafosol sodium on eyes with dry eye disease and meibomian gland dysfunction.

PubMed

Amano, Shiro; Inoue, Kenji

2017-01-01

To prospectively evaluate the effect of topical diquafosol sodium on eyes with dry eye disease (DED) and meibomian gland dysfunction (MGD). The subjects were consecutive patients diagnosed with both DED and MGD at Inouye Eye Hospital between March and September of 2016. The subjects were administered topical 3% diquafosol sodium ophthalmic solution six times a day for 3 months. At each study visit, subjects underwent slit-lamp examination and completed MGD symptoms and dry eye-related quality of life score (DEQS) questionnaires. Meibum quality (meibum score) and meibomian gland loss (meiboscore) were evaluated. Tear lipid layer thickness was measured in both eyes with an ocular surface interferometer immediately after clinic arrival and 20 minutes after instillation of one drop of topical diquafosol. Thirteen patients (3 men, 10 women) with a mean age of 69.5±8.3 years completed the 3-month study. The number of telangiectasia and plugged meibomian gland orifices significantly decreased from baseline after 1 month of diquafosol use. The meibum score and the meiboscore significantly decreased from baseline at 3 months. Also, the lipid layer thickness was greater after diquafosol administration than before administration at baseline and 1, 2, and 3 months by 12.2, 11.5, 9.5, and 17.0 nm, respectively, but this difference was only significant at 3 months ( p =0.039). The DEQS ocular symptom ( p =0.065) and MGD questionnaire ( p =0.081) scores tended to be lower than baseline at 3 months. Diquafosol sodium ophthalmic solution improves DED- and MGD-related signs in eyes with MGD.

Evaluation of endothelial mucin layer thickness after phacoemulsification with next generation ophthalmic irrigating solution.

PubMed

Ghate, Deepta A; Holley, Glenn; Dollinger, Harli; Bullock, Joseph P; Markwardt, Kerry; Edelhauser, Henry F

2008-10-01

To evaluate human corneal endothelial mucin layer thickness and ultrastructure after phacoemulsification and irrigation-aspiration with either next generation ophthalmic irrigating solution (NGOIS) or BSS PLUS. Paired human corneas were mounted in an artificial anterior chamber, exposed to 3 minutes of continuous ultrasound (US) at 80% power using the Alcon SERIES 20000 LEGACY surgical system (n = 9) or to 2 minutes of pulsed US at 50% power, 50% of the time at 20 pps using the Alcon INFINITI Vision System (n = 5), and irrigated with 250 mL of either NGOIS or BSS PLUS. A control group of paired corneas did not undergo phacoemulsification or irrigation-aspiration (n = 5). Corneas were divided and fixed for mucin staining or transmission electron microscopy. Mucin layer thickness was measured on the transmission electron microscopy prints. The mucin layer thickness in the continuous phaco group was 0.77 +/- 0.02 microm (mean +/- SE) with NGOIS and 0.51 +/- 0.01 microm with BSS PLUS (t test, P < 0.001). The mucin layer thickness in the pulsed phaco group was 0.79 +/- 0.02 microm with NGOIS and 0.54 +/- 0.01 microm with BSS PLUS (P < 0.001). The mucin layer thickness in the untreated control group was 0.72 +/- 0.02 microm. The endothelial ultrastructure was normal in all corneas. In this in vitro corneal model, NGOIS, due to its lower surface tension and higher viscosity, preserved endothelial mucin layer thickness better than BSS PLUS with both the INFINITI Vision System (pulsed US) and the LEGACY surgical system (continuous US).

Dendrimeric Systems and Their Applications in Ocular Drug Delivery

PubMed Central

Yavuz, Burçin; Bozdağ Pehlivan, Sibel; Ünlü, Nurşen

2013-01-01

Ophthalmic drug delivery is one of the most attractive and challenging research area for pharmaceutical scientists and ophthalmologists. Absorption of an ophthalmic drug in conventional dosage forms is seriously limited by physiological conditions. The use of nonionic or ionic biodegradable polymers in aqueous solutions and colloidal dosage forms such as liposomes, nanoparticles, nanocapsules, microspheres, microcapsules, microemulsions, and dendrimers has been studied to overcome the problems mentioned above. Dendrimers are a new class of polymeric materials. The unique nanostructured architecture of dendrimers has been studied to examine their role in delivery of therapeutics and imaging agents. Dendrimers can enhance drug's water solubility, bioavailability, and biocompatibility and can be applied for different routes of drug administration successfully. Permeability enhancer properties of dendrimers were also reported. The use of dendrimers can also reduce toxicity versus activity and following an appropriate application route they allow the delivery of the drug to the targeted site and provide desired pharmacokinetic parameters. Therefore, dendrimeric drug delivery systems are of interest in ocular drug delivery. In this review, the limitations related to eye's unique structure, the advantages of dendrimers, and the potential applications of dendrimeric systems to ophthalmology including imaging, drug, peptide, and gene delivery will be discussed. PMID:24396306

Lodoxamide Ophthalmic

MedlinePlus

Ophthalmic lodoxamide is used to treat redness, burning, itching, and swelling of the eyes that is caused by allergic reactions. Lodoxamide is in a class of medications called mast cell stabilizers. ...

Latanoprostene Bunod Ophthalmic

MedlinePlus

Latanoprostene bunod ophthalmic is used to treat glaucoma (condition in which increased pressure in the eye can lead to gradual loss of vision) and ocular hypertension (condition which causes increased pressure ...

An investigation of prescription and over-the-counter supply of ophthalmic chloramphenicol in Wales in the 5 years following reclassification.

PubMed

Du, Hank C T; John, Dai N; Walker, Roger

2014-02-01

The aims of the study were to (i) quantify the sales of over-the-counter (OTC) ophthalmic chloramphenicol from all community pharmacies in Wales and investigate the impact on primary care prescriptions up to 5 years after reclassification and (ii) investigate the temporal relationship between items supplied OTC and on NHS primary care prescriptions. Primary care prescription data (2004-2010) and OTC sales data (2005-2010) for ophthalmic chloramphenicol were obtained. The quantity sold OTC was calculated from pharmacy wholesale records and sales data from a large pharmacy multiple. Spearman's rank correlation for prescription and OTC supplies of ophthalmic chloramphenicol was calculated for data from January 2008 to December 2010. OTC supply of chloramphenicol eye drops and ointment were both highest in 2007-2008 and represented 68% (57,708/84,304) and 48% (22,875/47,192) of the corresponding prescription volume, respectively. There was a steady year-on-year increase in the combined supply of OTC ophthalmic chloramphenicol and that dispensed on prescription from 144,367 items in 2004-2005 to 210,589 in 2007-2008 before stabilising in 2008-2009 and 2009-2010. A significant positive correlation was observed between prescription items and OTC sales of chloramphenicol eye drops and ointment combined (r=0.7, P<0.001). OTC availability increased the total quantity of ophthalmic chloramphenicol supplied in primary care compared to that seen prior to reclassification. Although growth in the sales of ophthalmic chloramphenicol OTC has stabilised and the supply pattern mirrors primary care prescribers, further work is required to investigate whether use is appropriate and whether the publication of updated practice guidance has changed this. © 2013 The Authors. IJPP © 2013 Royal Pharmaceutical Society.

The incidence of neuro-ophthalmic diseases in Singapore: a prospective study in public hospitals.

PubMed

Lim, Su Ann; Wong, Wan Ling; Fu, Esther; Goh, Kong Yong; Seah, Alvin; Tan, Clement; Tow, Sharon; Cullen, James F; Wong, Tien Y

2009-01-01

To describe the incidence of neuro-ophthalmic diseases in a multi-ethnic Asian population in Singapore. Prospective study in public hospitals in Singapore. All neuro-ophthalmic cases seen in four public sector hospitals over a 22-month period (September 2002 to June 2004) were identified using a standardized protocol. The 2004 Singapore population was used as a denominator to estimate annual incidence. The prevalence of ischemic risk factors (hypertension, diabetes, and hypercholesterolemia) among cases was compared to population data. A total of 1,356 patients with neuro-ophthalmic diseases were seen during the study period, of which 627 were new incident cases. The overall annual incidence of neuro-ophthalmic diseases was 9.81 per 100,000 (95% confidence interval, 8.80-10.90). The incidence increased with age. After controlling for age, the annual incidence was similar between men (10.75 per 100,000) and women (9.00 per 100,000), but was higher in Chinese (10.33 per 100,000) and Indians (9.34 per 100,000) than in Malays (6.62 per 100,000). The three commonest specific neuro-ophthalmic conditions were abducens nerve palsy (1.27 per 100,000), anterior ischemic optic neuropathy (1.08 per 100,000) and oculomotor nerve palsy (0.91 per 100,000). The incidence of optic neuritis was 0.83 per 100,000. Compared with the Singapore general population, the prevalence of diabetes was significantly higher in people aged 40-59, while the prevalence of hypercholesterolemia was significantly higher in 60-69 year age group. In this study of public hospitals in Singapore, the incidence of neuro-ophthalmic diseases was higher in Chinese and Indians compared to Malays.

Outpatients flow management and ophthalmic electronic medical records system in university hospital using Yahgee Document View.

PubMed

Matsuo, Toshihiko; Gochi, Akira; Hirakawa, Tsuyoshi; Ito, Tadashi; Kohno, Yoshihisa

2010-10-01

General electronic medical records systems remain insufficient for ophthalmology outpatient clinics from the viewpoint of dealing with many ophthalmic examinations and images in a large number of patients. Filing systems for documents and images by Yahgee Document View (Yahgee, Inc.) were introduced on the platform of general electronic medical records system (Fujitsu, Inc.). Outpatients flow management system and electronic medical records system for ophthalmology were constructed. All images from ophthalmic appliances were transported to Yahgee Image by the MaxFile gateway system (P4 Medic, Inc.). The flow of outpatients going through examinations such as visual acuity testing were monitored by the list "Ophthalmology Outpatients List" by Yahgee Workflow in addition to the list "Patients Reception List" by Fujitsu. Patients' identification number was scanned with bar code readers attached to ophthalmic appliances. Dual monitors were placed in doctors' rooms to show Fujitsu Medical Records on the left-hand monitor and ophthalmic charts of Yahgee Document on the right-hand monitor. The data of manually-inputted visual acuity, automatically-exported autorefractometry and non-contact tonometry on a new template, MaxFile ED, were again automatically transported to designated boxes on ophthalmic charts of Yahgee Document. Images such as fundus photographs, fluorescein angiograms, optical coherence tomographic and ultrasound scans were viewed by Yahgee Image, and were copy-and-pasted to assigned boxes on the ophthalmic charts. Ordering such as appointments, drug prescription, fees and diagnoses input, central laboratory tests, surgical theater and ward room reservations were placed by functions of the Fujitsu electronic medical records system. The combination of the Fujitsu electronic medical records and Yahgee Document View systems enabled the University Hospital to examine the same number of outpatients as prior to the implementation of the computerized filing system.

Effect of rebamipide ophthalmic suspension on the success of lacrimal stent intubation.

PubMed

Mimura, Masashi; Ueki, Mari; Oku, Hidehiro; Sato, Bunpei; Ikeda, Tsunehiko

2016-02-01

To evaluate the effect of the postoperative administration of rebamipide ophthalmic suspension on the success rate of lacrimal stent intubation (LSI) for the treatment of primary acquired nasolacrimal duct obstruction (PANDO). This comparative interventional cohort study investigated 110 consecutive patients with PANDO who were treated with LSI and followed up for 12 months postoperatively at one institution. LSI was performed by one surgeon, and all patients received identical postoperative care. Among the total 110 patients, 71 underwent LSI with postoperative administration of rebamipide ophthalmic suspension, and 39 underwent LSI without administration of the suspension. Data related to patient age, gender, laterality, and postoperative administration of rebamipide ophthalmic suspension were collected and used as independent variables, and logistic regression analyses were performed to compare the anatomical success rate at 12 months postoperatively between patients with and without postoperative administration of the suspension. The anatomical success rate of LSI in patients with and without postoperative administration of rebamipide ophthalmic suspension was 90.1 and 69.2 %, respectively. A comparison of these success rates showed statistical significance, in that the rate of treatment success was higher in PANDO patients who underwent LSI with postoperative administration of the suspension [odds ratio (OR), 3.37; P < 0.05]. The findings of this study show that postoperative administration of rebamipide ophthalmic suspension increases the rate of anatomical success in patients who undergo LSI for the treatment of PANDO.

In Vivo Pharmacokinetics of Bromfenac Ophthalmic Solution 0.075%, Bromfenac Ophthalmic Solution 0.07%, and Nepafenac/Amfenac Ophthalmic Suspension 0.3% in Rabbits.

PubMed

Sheppard, John D; Cockrum, Paul C; Justice, Angela; Jasek, Mark C

2018-05-14

Little is known of the ocular distribution characteristics of currently branded non-steroidal anti-inflammatory drugs (NSAIDs) in the United States. This study was designed to predict the ocular bioavailability characteristics in humans using Dutch Belted rabbits as a surrogate. Commercially available, topically-applied NSAIDs containing bromfenac or nepafenac/amfenac were evaluated. 126 healthy adult Dutch Belted rabbits were randomly assigned to three treatment cohorts (BromSite ® twice daily [BID] in the right eye, BromSite ® once daily [QD] in the right eye, Prolensa ® QD in the right eye and Ilevro™ QD in the left eye) and 7 post-dosing time points (0.5, 1, 2, 4, 8, 12, 24 h after final instillation). The study eyes received 40 µL of the assigned drug for a consecutive 9 days. Samples of aqueous humor, iris-ciliary body, choroid, sclera, and retina were harvested from the study eyes at the assigned time point after the last dose on the 9th day. NSAID content in ocular tissues was analyzed using high-performance liquid chromatography (HPLC), and area under the curve (AUC 0.5-24h ), maximum concentration (C max ), and time to maximum concentration (T max ) were determined. Peak NSAID concentrations were reached within 1-3 h in the anterior segment and within 1-3 h in the posterior segment after last dose. Throughout the ocular tissues, both AUC and C max for BromSite ® (BID and QD) were consistently higher than respective NSAID concentrations of Prolensa ® QD and Ilevro ® QD. When comparing BromSite ® BID to QD, the BID regimen produced generally higher but statistically similar bromfenac concentrations throughout the ocular tissues except in the aqueous humor and iris-ciliary body, where the AUC BID was statistically significantly higher with BromSite ® BID. As a surrogate to human ocular bioavailability, BromSite ® demonstrated significantly greater NSAID compared to Prolensa ® QD and Ilevro ® QD. The DuraSite ® component of BromSite ® appears to enhance ocular penetration throughout both anterior and posterior tissues. Sun Pharmaceutical Industries Ltd.

Efficacy of sucrose to reduce pain in premature infants during eye examinations for retinopathy of prematurity.

PubMed

Gal, Peter; Kissling, Grace E; Young, William O; Dunaway, Kimberly K; Marsh, Virginia A; Jones, Susan M; Shockley, Dawn H; Weaver, Nicole L; Carlos, Rita Q; Ransom, J Laurence

2005-06-01

Eye examinations for retinopathy of prematurity (ROP) are painful to the neonate. The use of topical anesthetic for eye examinations to evaluate ROP is routine in our neonatal intensive care unit (NICU), but does not completely suppress painful responses. Sweet solutions have been shown to reduce procedural pain in newborns. To examine whether the addition of sucrose 24% to topical anesthetic improves procedural pain control during the ROP eye examination. Neonates born at < or = 30 weeks' gestation were included in this placebo-controlled, double-blind, crossover study. Patients were randomly assigned to receive treatment with either proparacaine HCl ophthalmic solution 0.5% plus 2 mL of sucrose 24% or proparacaine HCl ophthalmic solution 0.5% plus 2 mL of sterile water (placebo) prior to an eye examination. In a subsequent eye examination, each patient received the alternate treatment. Oral sucrose and sterile water were prepared in the pharmacy in identical syringes, and physicians, nurses, and pharmacists in the NICU were blinded to the treatment given. Pain was measured using the Premature Infant Pain Profile (PIPP) scoring system, which measures both physical and physiologic measures of pain, and the scores were simultaneously assessed by 2 study nurses. PIPP scores were recorded 1 and 5 minutes before and after the eye examination and during initial placement of the eye speculum. The same ophthalmologist performed all eye examinations. Several different definitions of a pain response were investigated. Twenty-three infants were studied, with 12 receiving sucrose and 11 receiving placebo as the first treatment. For 3 of the 5 definitions of pain response, patients experienced significantly less pain at speculum insertion with sucrose than with placebo. After the ROP examination, pain responses were similar with either sucrose or placebo. Oral sucrose may reduce the immediate pain response in premature infants undergoing eye examination for ROP.

Duration of IOP reduction with travoprost BAK-free solution.

PubMed

Gross, Ronald L; Peace, James H; Smith, Stephen E; Walters, Thomas R; Dubiner, Harvey B; Weiss, Mark J; Ochsner, Katherine I

2008-01-01

To compare the duration of action of travoprost ophthalmic solution 0.004% (Travatan Z) formulated without benzalkonium chloride (BAK) to travoprost ophthalmic solution 0.004% formulated with BAK (Travatan). This was a prospective, randomized, double-masked study. Patients with open-angle glaucoma or ocular hypertension were randomized to receive 2 weeks of once-daily therapy with travoprost BAK-free or travoprost with BAK. Patients received the last dose of medication on day 13 and then intraocular pressure (IOP) was assessed every 12 hours for 60 hours. Statistical analysis included change in IOP from baseline for each group and comparison of mean IOP between groups. Of the 109 patients enrolled, 106 patients completed the study. Untreated mean baseline IOP at 8 AM was 26.9 mm Hg in the travoprost BAK-free group and 27.1 mm Hg in the travoprost with BAK group. At 12, 24, 36, 48, and 60 hours after the last dose, mean IOP in the travoprost BAK-free group was 18.7, 17.2, 19.5, 18.7, and 20.8 mm Hg, respectively; whereas mean IOP in the travoprost with BAK group was 18.5, 16.8, 19.7, 18.0, and 20.8 mm Hg, respectively. Mean IOP at all time points after the last dose of medication was >6 mm Hg lower than the 8 AM baseline in both groups. Between-group differences were within +/-0.6 mm Hg at all postdose time points. There were no statistically significant differences between the 2 treatment groups at baseline or at any postdose time point. Drug-related side effects were uncommon, mild in intensity, and comparable between groups. Travoprost without BAK has similar IOP-lowering efficacy and safety compared with travoprost preserved with BAK. Both formulations of travoprost have a prolonged duration of action, with statistically and clinically significant reductions from baseline persisting up to 60 hours after the last dose.

Ability of bottle cap color to facilitate accurate glaucoma patient-physician communication regarding medication identity

PubMed Central

Dave, Pujan; Villarreal, Guadalupe; Friedman, David S.; Kahook, Malik Y.; Ramulu, Pradeep Y.

2015-01-01

Objective To determine the accuracy of patient-physician communication regarding topical ophthalmic medication use based on bottle cap color, particularly amongst individuals who may have acquired color vision deficiency from glaucoma. Design Cross-sectional, clinical study. Participants Patients ≥ 18 years old with primary open-angle, primary angle-closure, pseudoexfoliation, or pigment dispersion glaucoma, bilateral visual acuity of 20/400 or better, and no concurrent conditions that may affect color vision. Methods One hundred patients provided color descriptions of 11 distinct medication bottle caps. Patient-produced color descriptors were then presented to three physicians. Each physician matched each color descriptor to the medication they thought the descriptor was describing. Main Outcome Measures Frequency of patient-physician agreement, occurring when all three physicians accurately matched the patient-produced color descriptor to the correct medication. Multivariate regression models evaluated whether patient-physician agreement decreased with degree of better-eye visual field (VF) damage, color descriptor heterogeneity, and/or color vision deficiency, as determined by Hardy-Rand-Rittler (HRR) score and the Lanthony D15 testing index (D15 CCI). Results Subjects had a mean age of 69 (±11) years, with mean VF mean deviation of −4.7 (±6.0) and −10.9 (±8.4) dB in the better- and worse-seeing eyes, respectively. Patients produced 102 unique color descriptors to describe the colors of the 11 tested bottle caps. Among individual patients, the mean number of medications demonstrating patient-physician agreement was 6.1/11 (55.5%). Agreement was less than 15% for 4 medications (prednisolone acetate [generic], betaxolol HCl [Betoptic], brinzolamide/brimonidine [Simbrinza], and latanoprost [Xalatan]). Lower HRR scores and higher D15 CCI (both indicating worse color vision) were associated with greater VF damage (p<0.001). Extent of color vision deficiency and color descriptor heterogeneity were the only significant predictors of patient-physician agreement in multivariate models (odds of agreement = 0.90 per 1 point decrement in HRR score, p<0.001; odds of agreement = 0.30 for medications exhibiting high heterogeneity [≥ 11 descriptors], p=0.007). Conclusions Physician understanding of patient medication usage based solely on bottle cap color is frequently incorrect, particularly in glaucoma patients who may have color vision deficiency. Errors based on communication using bottle cap color alone may be common and could lead to confusion and harm. PMID:26260280

21 CFR 886.1120 - Opthalmic camera.

Code of Federal Regulations, 2010 CFR

2010-04-01

... DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1120 Opthalmic camera. (a) Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area...

Challenges Encountered Using Ophthalmic Anesthetics in Space Medicine

NASA Technical Reports Server (NTRS)

Bayuse, T.; Law, J.; Alexander, D.; Moynihan, S.; LeBlanc, C.; Langford, K.; Magalhaes, L.

2015-01-01

On orbit, ophthalmic anesthetics are used for tonometry and off-nominal corneal examinations. Proparacaine has been flown traditionally. However, the manufacturers recently changed its storage requirements from room temperature storage to refrigerated storage to preserve stability and prolong the shelf-life. Since refrigeration on orbit is not readily available and there were stability concerns about flying proparacaine unrefrigerated, tetracaine was selected as an alternative ophthalmic anesthetic in 2013. We will discuss the challenges encountered flying and using these anesthetics on the International Space Station.

Marfan syndrome presenting with headache and coincidental ophthalmic artery aneurysm.

PubMed

Vandersteen, Anthony Martin; Kenny, Joanna; Khan, Naheed L; Male, Alison

2013-03-15

A 24-year-old Ugandan woman was referred for a neurology opinion after complaining of a year long history of right-sided retro-orbital stabbing pain. Brain imaging revealed a coincidental 3 mm left ophthalmic artery aneurysm. Marfanoid habitus was noted; after further investigations she was diagnosed with mild aortic root dilatation, subtle lens dislocation and Marfan syndrome. Her symptoms were secondary to temporomandibular joint dysfunction, an under-recognised complication of Marfan syndrome. Her ophthalmic artery aneurysm is likely to be a coincidental finding.

[Biological availability of ophthalmic drugs. 1. Increasing drug permeability in the cornea].

PubMed

Masteiková, R; Chalupová, Z; Savickiene, N

2004-03-01

Most eye diseases are treated by topical administration of ophthalmic preparations. Low ophthalmic bioavailability is due to a number of physiological and physicochemical factors. The main obstacle to the penetration of active ingredients to the eye is the layered character of the cornea. Formulation of ophthalmic preparations enabling easier penetration of this biological barrier thus ranks among the most effective ways of improving bioavailability. Penetrability of the cornea can be increased by the following methods: a) adjustment of the actual acidity in such a way that pH of the preparation makes it possible to produce the optimal portion of non-ionized particles; b) incorporation of absorption enhancers (non-ionic tensides, salts of bile acids, some antimicrobial substances, EDTA, cyclodextrins, etc.) into the composition of the preparation, and c) production of prodrugs or ionic pairs.

Screening of diabetics for retinopathy by ophthalmic opticians.

PubMed Central

Burns-Cox, C J; Hart, J C

1985-01-01

Diabetes mellitus is a major cause of blindness in England and Wales in those aged between 30 and 64. Photocoagulation can frequently prevent blindness provided the retinopathy is detected at an appropriate stage but unfortunately the benefits are small if the changes are advanced. Early detection of diabetic retinopathy by regular examination is needed. We have shown that ophthalmic opticians have the skill to detect retinal changes at a treatable stage. Out of 844 eye checks, 80 were reported by ophthalmic opticians to justify referral to an ophthalmologist and 20 of these required photocoagulation treatment. Of a sample of 197 patients rechecked by an ophthalmologist reported by ophthalmic opticians not to justify referral, only one needed treatment. With local agreement this system of detecting retinopathy could be easily applied anywhere in the United Kingdom. No extra personnel or facilities are needed. PMID:3921106

Screening of diabetics for retinopathy by ophthalmic opticians.

PubMed

Burns-Cox, C J; Hart, J C

1985-04-06

Diabetes mellitus is a major cause of blindness in England and Wales in those aged between 30 and 64. Photocoagulation can frequently prevent blindness provided the retinopathy is detected at an appropriate stage but unfortunately the benefits are small if the changes are advanced. Early detection of diabetic retinopathy by regular examination is needed. We have shown that ophthalmic opticians have the skill to detect retinal changes at a treatable stage. Out of 844 eye checks, 80 were reported by ophthalmic opticians to justify referral to an ophthalmologist and 20 of these required photocoagulation treatment. Of a sample of 197 patients rechecked by an ophthalmologist reported by ophthalmic opticians not to justify referral, only one needed treatment. With local agreement this system of detecting retinopathy could be easily applied anywhere in the United Kingdom. No extra personnel or facilities are needed.

Ophthalmic Manifestations of Congenital Zika Syndrome in Colombia and Venezuela.

PubMed

Yepez, Juan B; Murati, Felipe A; Pettito, Michele; Peñaranda, Carlos F; de Yepez, Jazmin; Maestre, Gladys; Arevalo, J Fernando

2017-05-01

The ocular manifestations and sequelae of Zika virus infection are not well known. Recently, the World Health Organization changed the declaration of Zika as a public health emergency and designated the viral outbreak and related microcephaly clusters as a long-term program of work. This change indicates the urgent need to evaluate and document ophthalmic manifestations in patients for timely management of this disease. In addition, confirmation whether the public health problem in Brazil extends to other regions in South America is needed. To report the ocular manifestations of congenital Zika syndrome with microcephaly in Colombia and Venezuela. This prospective case series included 43 patients from 2 ophthalmic centers in Colombia and Venezuela who underwent evaluation from October 1, 2015, through June 30, 2016, and were clinically diagnosed with congenital Zika syndrome. Twenty patients were Hispanic; 13, African; 8, white; and 2, Native American. Ophthalmic and systemic evaluations and serologic testing were performed on all infants. Patients underwent external ocular examination and dilated ophthalmoscopy. Serologic testing ruled out toxoplasmosis, rubella, cytomegalovirus, syphilis, and human immunodeficiency virus. Ophthalmic manifestations of congenital Zika syndrome. Of the 43 patients included in this series (28 female and 15 male), the mean (SD) age at examination was 2.1 (1.5) months. The mothers of all the children had no ophthalmic findings and did not report ocular symptoms during pregnancy. All patients had bilateral ophthalmic manifestations. Optic nerve findings included hypoplasia with the double-ring sign, pallor, and increased cup-disc ratio in 5 patients (11.6%). Macular abnormalities included mild to severe pigment mottling in 27 patients (63%) and lacunar maculopathy in 3 (6.9%). Chorioretinal scarring was present in 3 patients (7%). Eleven patients (26%) had a combination of lesions in the posterior pole. Five patients (12%) were diagnosed with congenital glaucoma, characterized by the clinical triad of epiphora, photophobia, and blepharospasm; increased intraocular pressure; corneal clouding at birth; and buphthalmos. These data reveal that 12% (95% CI, 5%-24%) of cases of congenital Zika with microcephaly had anterior segment abnormalities and 88% (95% CI, 76%-94%) had important macular and optic nerve abnormalities. The visual sequelae of these ophthalmic manifestations remain unknown. Congenital Zika syndrome in the current study had severe ocular abnormalities, and all patients had bilateral involvement. Ocular findings were focal macular pigment mottling, chorioretinal atrophy with a predilection for the macular area, congenital glaucoma and optical nerve hypoplasia, and optic disc abnormalities. Ophthalmic examination is recommended in patients with congenital Zika syndrome.

The incidence of ocular candidiasis and evaluation of routine opthalmic examination in critically ill patients with candidaemia.

PubMed

Gluck, S; Headdon, W G; Tang, Dws; Bastian, I B; Goggin, M J; Deane, A M

2015-11-01

Despite a paucity of data regarding both the incidence of ocular candidiasis and the utility of ophthalmic examination in critically ill patients, routine ophthalmic examination is recommended for critically ill patients with candidaemia. The objectives were to estimate the incidence of ocular candidiasis and evaluate whether ophthalmic examination influenced subsequent management of these patients. We conducted a ten-year retrospective observational study. Data were extracted for all ICU patients who were blood culture positive for fungal infection. Risk factors for candidaemia and eye involvement were quantified and details regarding ophthalmic examination were reviewed. Candida species were cultured in 93 patients. Risk factors for ocular candidiasis were present in 57% of patients. Forty-one percent of patients died prior to ophthalmology examination and 2% of patients were discharged before candidaemia was identified. During examination, signs of ocular candidiasis were only present in one (2.9%) patient, who had a risk factor for ocular candidiasis. Based on these findings, the duration of antifungal treatment for this patient was increased. Ocular candidiasis occurs rarely in critically ill patients with candidaemia, but because treatment regimens may be altered when diagnosed, routine ophthalmic examination is still indicated.

Superior ophthalmic vein enlargement and increased muscle index in dysthyroid optic neuropathy.

PubMed

Lima, Breno da Rocha; Perry, Julian D

2013-01-01

To compare superior ophthalmic vein diameter and extraocular muscle index in patients with thyroid eye disease with or without optic neuropathy. High-resolution CT scan images of 40 orbits of 20 patients with history of thyroid eye disease (with or without optic neuropathy), who underwent orbital decompression surgery from January 2007 to November 2009, were retrospectively reviewed. Superior ophthalmic vein diameter was measured in coronal and axial planes. Extraocular muscle index was calculated according to the method proposed by Barrett et al. The clinical diagnosis of optic neuropathy was based on characteristic signs that included afferent pupillary defect, decreased visual acuity, visual field defects, and dyschromatopsia. Orbits were divided in 2 groups based on presence or absence of optic neuropathy. Superior ophthalmic vein diameter was significantly higher in orbits with concomitant optic neuropathy (mean 2.4 ± 0.4mm, p < 0.0001). Increased muscle index was also related to optic neuropathy (mean 57.9% ± 5.7%, p = 0.0002). Muscle index greater than 50% was present in all patients with dysthyroid optic neuropathy. This study suggests that patients with thyroid eye disease with enlarged superior ophthalmic vein and increased extraocular muscle index are more likely to have concomitant optic neuropathy.

Comparative analysis of image classification methods for automatic diagnosis of ophthalmic images

NASA Astrophysics Data System (ADS)

Wang, Liming; Zhang, Kai; Liu, Xiyang; Long, Erping; Jiang, Jiewei; An, Yingying; Zhang, Jia; Liu, Zhenzhen; Lin, Zhuoling; Li, Xiaoyan; Chen, Jingjing; Cao, Qianzhong; Li, Jing; Wu, Xiaohang; Wang, Dongni; Li, Wangting; Lin, Haotian

2017-01-01

There are many image classification methods, but it remains unclear which methods are most helpful for analyzing and intelligently identifying ophthalmic images. We select representative slit-lamp images which show the complexity of ocular images as research material to compare image classification algorithms for diagnosing ophthalmic diseases. To facilitate this study, some feature extraction algorithms and classifiers are combined to automatic diagnose pediatric cataract with same dataset and then their performance are compared using multiple criteria. This comparative study reveals the general characteristics of the existing methods for automatic identification of ophthalmic images and provides new insights into the strengths and shortcomings of these methods. The relevant methods (local binary pattern +SVMs, wavelet transformation +SVMs) which achieve an average accuracy of 87% and can be adopted in specific situations to aid doctors in preliminarily disease screening. Furthermore, some methods requiring fewer computational resources and less time could be applied in remote places or mobile devices to assist individuals in understanding the condition of their body. In addition, it would be helpful to accelerate the development of innovative approaches and to apply these methods to assist doctors in diagnosing ophthalmic disease.

Color Doppler Imaging Analysis of Retrobulbar Blood Flow Velocities in Diabetic Patients Without or With Retinopathy: A Meta-analysis.

PubMed

Meng, Nana; Liu, Jing; Zhang, Yue; Ma, Jinlan; Li, Hao; Qu, Yi

2014-08-01

To analyze hemodynamic changes in retrobulbar blood vessels using color Doppler imaging in diabetic patients without or with retinopathy. Pertinent publications were retrieved from 3 databases. Changes in peak systolic velocity (PSV), end-diastolic velocity (EDV), and resistive index (RI) of the ophthalmic artery, central retinal artery, and short posterior ciliary artery of diabetic eyes without or with retinopathy and healthy controls were evaluated by color Doppler imaging. Comparisons were conducted in 3 groups: group 1, no retinopathy versus control; group 2, retinopathy versus control; and group 3, no retinopathy versus retinopathy. In group 1, eyes without retinopathy had a significant increase in ophthalmic artery PSV (P = .002), with no heterogeneity (Pheterogeneity = 0.09; inconsistency index [I(2)] = 46%); however, significant reductions in central renal artery PSV and EDV were shown (P = .002; P = .007, respectively), with significant heterogeneity (Pheterogeneity < .00001; I(2) = 85%; Pheterogeneity = .008, I(2) = 68%). A significant increase in ophthalmic artery RI (P = .02) was found in eyes without retinopathy, with heterogeneity (Pheterogeneity = .0009; I(2) = 74%). In group 2, central retinal artery PSV and EDV in eyes with retinopathy decreased significantly (P < 0.00001). Similar results were found for ophthalmic and short posterior ciliary artery EDVs (P= .0003; P< .00001). Ophthalmic artery RI was significantly higher in eyes with retinopathy than controls (P = .0008), with heterogeneity (Pheterogeneity < .00001; I(2) = 84%). In group 3, ophthalmic artery PSV was lower in eyes with retinopathy (P= .04) than eyes without, and central retinal artery PSV and EDV decreased significantly (P = .004; P < .00001) in eyes with retinopathy compared to eyes without. Differences in ophthalmic and central retinal artery RIs were also found in eyes with retinopathy (P = .05; P < .00001). Significant changes in retrobulbar blood flow were found in eyes without and with diabetic retinopathy, especially those with retinopathy. © 2014 by the American Institute of Ultrasound in Medicine.

Efficacy of Rebamipide Instillation for Contact Lens Discomfort With Dry Eye.

PubMed

Igarashi, Tsutomu; Kobayashi, Maika; Yaguchi, Chiemi; Fujimoto, Chiaki; Suzuki, Hisaharu; Takahashi, Hiroshi

2017-11-10

To examine the effects of rebamipide ophthalmic solution on the symptoms, signs, and cytokine concentrations in tear fluid among soft contact lens (SCL) wearers with Dry eye disease (DED). From November 2015 to June 2017, this open-label, single-arm study examined 40 eyes of 20 SCL wearers with DED who had been using daily disposable SCLs for >3 months (mean age, 30.0±8.33 years; range, 20-47 years). Signs, symptoms, and cytokine concentrations were assessed before and 4 weeks after starting 2% rebamipide ophthalmic solution 4 times/day. Dry eye disease was diagnosed according to: compromised tear dynamics (Schirmer test ≤5 mm or tear break-up time (TBUT) ≤5 sec); ocular surface abnormalities (positive vital staining with fluorescein or lissamine green); and presence of symptoms. Touch thresholds using a Cochet-Bonnet anesthesiometer were also determined for the cornea and conjunctivae. Symptoms were assessed using the 12-item Ocular Surface Disease Index questionnaire. Concentrations of cytokines in tear fluid were measured. Significant improvements in signs were seen for TBUT, surface abnormalities, and touch thresholds. Ocular Surface Disease Index scores likewise improved significantly in all the 12 items. Of the cytokines measured, only interleukin-1β, interleukin-8, and monocyte chemotactic protein-1 were found in ≥60% of tear samples, with no significant differences in concentrations before and after rebamipide use. Rebamipide significantly improved all signs and symptoms in patients with DED who wore daily disposable SCLs. Rebamipide is effective for DED treatment with SCL wear.This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

SkQ1 Ophthalmic Solution for Dry Eye Treatment: Results of a Phase 2 Safety and Efficacy Clinical Study in the Environment and During Challenge in the Controlled Adverse Environment Model.

PubMed

Petrov, Anton; Perekhvatova, Natalia; Skulachev, Maxim; Stein, Linda; Ousler, George

2016-01-01

This Phase 2 clinical trial assessed the efficacy and safety of the novel antioxidative, renewable compound SkQ1 for topical treatment of dry eye signs and symptoms. In a single-center, randomized, double-masked, placebo-controlled, 29-day study, 91 subjects with mild to moderate dry eye instilled the study drug twice daily and recorded dry eye symptoms daily. Subjects were randomized 1:1:1 into one of three ophthalmic solution treatment groups: SkQ1 1.55 µg/mL, SkQ1 0.155 µg/mL, or 0.0 µg/mL (placebo). Subjects were exposed to a controlled adverse environment chamber at 3 of the 4 study visits (Day -7, Day 1, and Day 29). Investigator assessments occurred at all study visits. SkQ1 was safe and efficacious in treating dry eye signs and symptoms. Statistically significant improvements with SkQ1 compared to placebo occurred for the dry eye signs of corneal fluorescein staining and lissamine green staining in the central region and lid margin redness, and for the dry eye symptoms of ocular discomfort, dryness, and grittiness. In addition, SkQ1 demonstrated greater efficacy compared to placebo, although the differences were not statistically significant, for corneal fluorescein staining in other regions and/or time points (total staining score, central region, corneal sum score, and temporal region), lissamine green staining for the central and nasal regions, and blink rate scores. This Phase 2 study indicated that SkQ1 is safe and efficacious for the treatment of dry eye signs and symptoms and supported previous study results. Clinicaltrials.gov identifier: NCT02121301. Miotech S.A.

Cyclosporine Amicellar delivery system for dry eyes.

PubMed

Kang, Han; Cha, Kwang-Ho; Cho, Wonkyung; Park, Junsung; Park, Hee Jun; Sun, Bo Kyung; Hyun, Sang-Min; Hwang, Sung-Joo

2016-01-01

The objectives of this study were to develop stable cyclosporine A (CsA) ophthalmic micelle solutions for dry-eye syndrome and evaluate their physicochemical properties and therapeutic efficacy. CsA-micelle solutions (MS-CsA) were created by a simple method with Cremophor EL, ethanol, and phosphate buffer. We investigated the particle size, pH, and osmolarity. In addition, long-term physical and chemical stability for MS-CsA was observed. To confirm the therapeutic efficacy, tear production in dry eye-induced rabbits was evaluated using the Schirmer tear test (STT). When compared to a commercial product, Restasis, MS-CsA demonstrated improvement in goblet-cell density and conjunctival epithelial morphology, as demonstrated in histological hematoxylin and eosin staining. MS-CsA had a smaller particle size (average diameter 14-18 nm) and a narrow size distribution. Physicochemical parameters, such as particle size, pH, osmolarity, and remaining CsA concentration were all within the expected range of 60 days. STT scores significantly improved in MS-CsA treated groups (P<0.05) in comparison to those of the Restasis-treated group. The number of goblet cells for rabbit conjunctivas after the administration of MS-CsA was 94.83±8.38, a significantly higher result than the 65.17±11.51 seen with Restasis. The conjunctival epithelial morphology of dry eye-induced rabbits thinned with loss of goblet cells. However, after 5 days of treatment with drug formulations, rabbit conjunctivas recovered epithelia and showed a relative increase in the number of goblet cells. The results of this study indicate the potential use of a novel MS for the ophthalmic delivery of CsA in treating dry eyes.

Changes in Tear Volume after 3% Diquafosol Treatment in Patients with Dry Eye Syndrome: An Anterior Segment Spectral-domain Optical Coherence Tomography Study.

PubMed

Lee, Kwan Bok; Koh, Kyung Min; Kwon, Young A; Song, Sang Wroul; Kim, Byoung Yeop; Chung, Jae Lim

2017-08-01

To evaluate changes in the tear meniscus area and tear meniscus height over time in patients with dry eye syndrome, using anterior segment spectral-domain optical coherence tomography after the instillation of 3% diquafosol ophthalmic solution. Sixty eyes from 30 patients with mild to moderate dry eye syndrome were included. Tear meniscus images acquired by anterior segment spectral-domain optical coherence tomography were analyzed using National Institutes of Health's image-analysis software (ImageJ 1.44p). Tear meniscus area and tear meniscus height were measured at baseline, 5 minutes, 10 minutes, and 30 minutes after instillation of a drop of diquafosol in one eye and normal saline in the other eye. Changes in ocular surface disease index score, tear film break-up time, corneal staining score by Oxford schema, and meibomian expressibility were also evaluated at baseline, and after 1 week and 1 month of a diquafosol daily regimen. Sixty eyes from 30 subjects (mean age, 29.3 years; 8 men and 22 women) were included. In eyes receiving diquafosol, tear volume was increased at 5 and 10 minutes compared with baseline. It was also higher than saline instilled eyes at 5, 10, and 30 minutes. Changes in tear volume with respect to baseline were not statistically different after the use of diquafosol for 1 month. Ocular surface disease index score, tear film break-up time, and Oxford cornea stain score were significantly improved after 1 week and 1 month of daily diquafosol instillation, but meibomian expressibility did not change. Topical diquafosol ophthalmic solution effectively increased tear volume for up to 30 minutes, compared to normal saline in patients with dry eye syndrome. © 2017 The Korean Ophthalmological Society

Cyclosporine Amicellar delivery system for dry eyes

PubMed Central

Kang, Han; Cha, Kwang-Ho; Cho, Wonkyung; Park, Junsung; Park, Hee Jun; Sun, Bo Kyung; Hyun, Sang-Min; Hwang, Sung-Joo

2016-01-01

Background The objectives of this study were to develop stable cyclosporine A (CsA) ophthalmic micelle solutions for dry-eye syndrome and evaluate their physicochemical properties and therapeutic efficacy. Materials and methods CsA-micelle solutions (MS-CsA) were created by a simple method with Cremophor EL, ethanol, and phosphate buffer. We investigated the particle size, pH, and osmolarity. In addition, long-term physical and chemical stability for MS-CsA was observed. To confirm the therapeutic efficacy, tear production in dry eye-induced rabbits was evaluated using the Schirmer tear test (STT). When compared to a commercial product, Restasis, MS-CsA demonstrated improvement in goblet-cell density and conjunctival epithelial morphology, as demonstrated in histological hematoxylin and eosin staining. Results MS-CsA had a smaller particle size (average diameter 14–18 nm) and a narrow size distribution. Physicochemical parameters, such as particle size, pH, osmolarity, and remaining CsA concentration were all within the expected range of 60 days. STT scores significantly improved in MS-CsA treated groups (P<0.05) in comparison to those of the Restasis-treated group. The number of goblet cells for rabbit conjunctivas after the administration of MS-CsA was 94.83±8.38, a significantly higher result than the 65.17±11.51 seen with Restasis. The conjunctival epithelial morphology of dry eye-induced rabbits thinned with loss of goblet cells. However, after 5 days of treatment with drug formulations, rabbit conjunctivas recovered epithelia and showed a relative increase in the number of goblet cells. Conclusion The results of this study indicate the potential use of a novel MS for the ophthalmic delivery of CsA in treating dry eyes. PMID:27382280

Efficacy and safety of topical diquafosol ophthalmic solution for treatment of dry eye: a systematic review of randomized clinical trials.

PubMed

Wu, Di; Chen, Wang Qi; Li, Ryan; Wang, Yan

2015-06-01

To evaluate the efficacy and safety of topical diquafosol ophthalmic solution for treatment of dry eye. Randomized clinical trials (RCTs) from MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) were identified to evaluate the efficacy and safety of topical administration of diquafosol to patients with dry eyes. Data evaluation was based on endpoints including Schirmer test, tear film break-up time, ocular surface staining score, subjective symptom score, and adverse events. A total of 8 RCTs involving 1516 patients were selected based on the prespecified criteria. Significant improvement of Schirmer test values and tear film break-up time were reported in 40% (2 of 5) and 80% (4 of 5) studies, respectively. Ocular surface staining scores significantly decreased in 100% (fluorescein corneal staining, 6 of 6; Rose Bengal corneal and conjunctival staining, 4 of 4) RCTs. Symptoms significantly improved in 75% (6 of 8) RCTs in patients with dry eyes. No severe adverse events were reported with the concentration of diquafosol from 0.5% to 5%. Heterogeneity in study design prevented meta-analysis from statistical integration and summarization. Topical diquafosol seems to be a safe therapeutic option for the treatment of dry eye. The high variability of the selected RCTs compromised the strength of evidence and limits the determination of efficacy. However, the topical administration of diquafosol seems to be beneficial in improving the integrity of the epithelial cell layer of the ocular surface and mucin secretion in patients with dry eyes. This review indicates a need for standardized criteria and methods for evaluation to assess the efficacy of diquafosol in the future clinical trials.

Simulation of Ophthalmic Alterations at the Arctic, Antarctica and the International Space Station for Long-Duration Spaceflight

NASA Astrophysics Data System (ADS)

De Morais Mendonca Teles, Antonio; Gonçalves, Cristiane

2016-07-01

Well, we propose a series of long-period medical simulations in scientific bases at the Arctic, at Antarctica and aboard the International Space Station (ISS), involving natural ophthalmic diseases such as radiation, solar and trauma retinopathy, keratoconus, cataract, glaucoma, etc., and ophthalmic alterations by accidental injuries. These natural diseases, without a previous diagnosis, specially those specific retinopathy, appear after 1 month to 1.5 year, in average. Such studies will be valuable for the human deep-space exploration because during long-duration spaceflight, such as staying at the ISS, a Moon base and a manned trip to planet Mars, requires several months within such environments, and during such periods ophthalmic diseases and accidents might eventually occur, which could seriously affect the 'round-the-clock' work schedule of the astronauts and the long-duration spaceflight manned program.

Ophthalmic Start-Up Chief Executive Officers' Perceptions of Development Hurdles.

PubMed

Stewart, William C; Nelson, Lindsay A; Kruft, Bonnie; Stewart, Jeanette A

2018-01-01

To identify current challenges facing ophthalmic pharmaceutical start-ups in developing new products. Surveys were distributed to the chief executive officer (CEO) or president of ophthalmic start-ups. The survey attracted 24 responses from 78 surveys distributed (31%). The CEOs stated that a lack of financial capital (n = 18, 75%), FDA regulations (n = 6, 25%), and failure to meet clinical endpoints (n = 6, 25%) were their greatest development hurdles. Risk aversion to medicines in early development (n = 18, 75%), mergers and acquisitions reducing corporate choice for licensing agreements (n = 7, 29%), the emergence of large pharmaceutical-based venture capital funding groups (n = 12, 50%), and the failure of many large pharmaceutical companies to develop their own medicines (n = 10, 42%) were noted as recent prominent trends affecting fundraising. The study suggests that development funding, regulatory burden, and meeting clinical endpoints are the greatest development challenges faced by ophthalmic start-up CEOs. © 2017 S. Karger AG, Basel.

Ophthalmic drug dosage forms: characterisation and research methods.

PubMed

Baranowski, Przemysław; Karolewicz, Bożena; Gajda, Maciej; Pluta, Janusz

2014-01-01

This paper describes hitherto developed drug forms for topical ocular administration, that is, eye drops, ointments, in situ gels, inserts, multicompartment drug delivery systems, and ophthalmic drug forms with bioadhesive properties. Heretofore, many studies have demonstrated that new and more complex ophthalmic drug forms exhibit advantage over traditional ones and are able to increase the bioavailability of the active substance by, among others, reducing the susceptibility of drug forms to defense mechanisms of the human eye, extending contact time of drug with the cornea, increasing the penetration through the complex anatomical structure of the eye, and providing controlled release of drugs into the eye tissues, which allows reducing the drug application frequency. The rest of the paper describes recommended in vitro and in vivo studies to be performed for various ophthalmic drugs forms in order to assess whether the form is acceptable from the perspective of desired properties and patient's compliance.

Fast scanning probe for ophthalmic echography using an ultrasound motor.

PubMed

Carotenuto, Riccardo; Caliano, Giosuè; Caronti, Alessandro; Savoia, Alessandro; Pappalardo, Massimo

2005-11-01

High-frequency transducers, up to 35-50 MHz, are widely used in ophthalmic echography to image fine eye structures. Phased-array techniques are not practically applicable at such a high frequency, due to the too small size required for the single transducer element, and mechanical scanning is the only practical alternative. At present, all ophthalmic ultrasound systems use focused single-element, mechanically scanned probes. A good probe positioning and image evaluation feedback requires an image refresh-rate of about 15-30 frames per second, which is achieved in commercial mechanical scanning probes by using electromagnetic motors. In this work, we report the design, construction, and experimental characterization of the first mechanical scanning probe for ophthalmic echography based on a small piezoelectric ultrasound motor. The prototype probe reaches a scanning rate of 15 sectors per second, with very silent operation and little weight. The first high-frequency echographic images obtained with the prototype probe are presented.

Ophthalmic Drug Dosage Forms: Characterisation and Research Methods

PubMed Central

Baranowski, Przemysław; Karolewicz, Bożena; Gajda, Maciej; Pluta, Janusz

2014-01-01

This paper describes hitherto developed drug forms for topical ocular administration, that is, eye drops, ointments, in situ gels, inserts, multicompartment drug delivery systems, and ophthalmic drug forms with bioadhesive properties. Heretofore, many studies have demonstrated that new and more complex ophthalmic drug forms exhibit advantage over traditional ones and are able to increase the bioavailability of the active substance by, among others, reducing the susceptibility of drug forms to defense mechanisms of the human eye, extending contact time of drug with the cornea, increasing the penetration through the complex anatomical structure of the eye, and providing controlled release of drugs into the eye tissues, which allows reducing the drug application frequency. The rest of the paper describes recommended in vitro and in vivo studies to be performed for various ophthalmic drugs forms in order to assess whether the form is acceptable from the perspective of desired properties and patient's compliance. PMID:24772038

Genotype, B-vitamin status, and androgens affect spaceflight-induced ophthalmic changes

PubMed Central

Zwart, Sara R.; Gregory, Jesse F.; Zeisel, Steven H.; Gibson, Charles R.; Mader, Thomas H.; Kinchen, Jason M.; Ueland, Per M.; Ploutz-Snyder, Robert; Heer, Martina A.; Smith, Scott M.

2016-01-01

Ophthalmic changes have occurred in a subset of astronauts on International Space Station missions. Visual deterioration is considered the greatest human health risk of spaceflight. Affected astronauts exhibit higher concentrations of 1-carbon metabolites (e.g., homocysteine) before flight. We hypothesized that genetic variations in 1-carbon metabolism genes contribute to susceptibility to ophthalmic changes in astronauts. We investigated 5 polymorphisms in the methionine synthase reductase (MTRR), methylenetetrahydrofolate reductase (MTHFR), serine hydroxymethyltransferase (SHMT), and cystathionine β-synthase (CBS) genes and their association with ophthalmic changes after flight in 49 astronauts. The number of G alleles of MTRR 66 and C alleles of SHMT1 1420 both contributed to the odds of visual disturbances. Preflight dehydroepiandrosterone was positively associated with cotton wool spots, and serum testosterone response during flight was associated with refractive change. Block regression showed that B-vitamin status and genetics were significant predictors of many of the ophthalmic outcomes that we observed. In one example, genetics trended toward improving (P = 0.10) and B-vitamin status significantly improved (P < 0.001) the predictive model for refractive change after flight. We document an association between MTRR 66 and SHMT1 1420 polymorphisms and spaceflight-induced vision changes. This line of research could lead to therapeutic options for both space travelers and terrestrial patients.—Zwart, S. R., Gregory, J. F., Zeisel, S. H., Gibson, C. R., Mader, T. H., Kinchen, J. M., Ueland, P. M., Ploutz-Snyder, R., Heer, M. A., Smith, S. M. Genotype, B-vitamin status, and androgens affect spaceflight-induced ophthalmic changes. PMID:26316272

Current Perspectives on Ophthalmic Mycoses

PubMed Central

Thomas, Philip A.

2003-01-01

Fungi may infect the cornea, orbit and other ocular structures. Species of Fusarium, Aspergillus, Candida, dematiaceous fungi, and Scedosporium predominate. Diagnosis is aided by recognition of typical clinical features and by direct microscopic detection of fungi in scrapes, biopsy specimens, and other samples. Culture confirms the diagnosis. Histopathological, immunohistochemical, or DNA-based tests may also be needed. Pathogenesis involves agent (invasiveness, toxigenicity) and host factors. Specific antifungal therapy is instituted as soon as the diagnosis is made. Amphotericin B by various routes is the mainstay of treatment for life-threatening and severe ophthalmic mycoses. Topical natamycin is usually the first choice for filamentous fungal keratitis, and topical amphotericin B is the first choice for yeast keratitis. Increasingly, the triazoles itraconazole and fluconazole are being evaluated as therapeutic options in ophthalmic mycoses. Medical therapy alone does not usually suffice for invasive fungal orbital infections, scleritis, and keratitis due to Fusarium spp., Lasiodiplodia theobromae, and Pythium insidiosum. Surgical debridement is essential in orbital infections, while various surgical procedures may be required for other infections not responding to medical therapy. Corticosteroids are contraindicated in most ophthalmic mycoses; therefore, other methods are being sought to control inflammatory tissue damage. Fungal infections following ophthalmic surgical procedures, in patients with AIDS, and due to use of various ocular biomaterials are unique subsets of ophthalmic mycoses. Future research needs to focus on the development of rapid, species-specific diagnostic aids, broad-spectrum fungicidal compounds that are active by various routes, and therapeutic modalities which curtail the harmful effects of fungus- and host tissue-derived factors. PMID:14557297

21 CFR 524.154 - Bacitracin or bacitracin zinc-neomycin sulfate-polymyxin B sulfate ophthalmic ointment.

Code of Federal Regulations, 2011 CFR

2011-04-01

... organisms. (3) Limitations. Laboratory tests should be conducted including in vitro culturing and... sulfate ophthalmic ointment. (a) Sponsor. To firms identified in § 510.600(c) of this chapter as follows...

21 CFR 524.154 - Bacitracin or bacitracin zinc-neomycin sulfate-polymyxin B sulfate ophthalmic ointment.

Code of Federal Regulations, 2010 CFR

2010-04-01

... organisms. (3) Limitations. Laboratory tests should be conducted including in vitro culturing and... sulfate ophthalmic ointment. (a) Sponsor. To firms identified in § 510.600(c) of this chapter as follows...

Nanogel-based natural polymers as smart carriers for the controlled delivery of Timolol Maleate through the cornea for glaucoma.

PubMed

Ilka, Roya; Mohseni, Mojdeh; Kianirad, Mehran; Naseripour, Masood; Ashtari, Khadijeh; Mehravi, Bita

2018-04-01

Despite frequent scientific efforts, efficient ocular drug delivery is a major challenge for pharmaceutical scientists. Poor bioavailability of ophthalmic solutions can be overcome by using smart ophthalmic drug-delivery systems. In this research, loading and delivery of Timolol Maleate (TM) through the cornea by synthesized nanoparticles based on biopolymers (chitosan-alginate) were studied. The physico-chemical properties of these nanoparticles were characterized using scanning electron microscopy (SEM), transmission electron microscopy (TEM) and dynamic light scattering (DLS). Loading and release were evaluated by a UV-vis spectrometer and the ex vivo permeation study was carried out using the Franz Diffusion Cell and fluorescent microscopy studies. The results indicated that morphology and size of nanoparticles were spherical and in the range of 80-100nm. The loading capacity and encapsulation efficiency were about 42% and 94% respectively. They illustrated a burst release in the first hour followed by a slower and more sustained drug release during the next 24h. Also, the results indicated that the cornea penetration of TM loaded in nanoparticles was twice than that of TM. Hence, this nanocarrier can be considered as a suitable candidate for controlled TM delivery and release through the cornea. Copyright © 2017 Elsevier B.V. All rights reserved.

Stability-Indicating HPTLC Method for Simultaneous Estimation of Flurbiprofen and Chloramphenicol in Ophthalmic Solution.

PubMed

Sadakwala, Vaishnavi M; Chauhan, Renu S; Shah, Shailesh A; Shah, Dinesh R

2016-01-01

A specific, accurate and reproducible stability-indicating high performance thin layer chromatography (HPTLC) method was developed for the estimation of flurbiprofen and chloramphenicol in the presence of their degradation products. Degradation studies of both the drugs were carried out in acidic, alkaline, neutral, oxidative, photolytic and thermal stress conditions. Separation was performed on thin layer chromatography plate precoated with silica gel 60 F254 using ethyl acetate : n-hexane : methanol : tri-ethyl amine (5 : 4 : 2 : 0.5, v/v/v/v). Spots at retention factor 0.29 and 0.62 were recognized as flurbiprofen and chloramphenicol, respectively, and were quantified through densitometric measurements at wavelength 267 nm. Method was found to be linear over the concentration range 12-60 ng/spot with correlation coefficient of 0.9997 for flurbiprofen and 200-1,000 ng/spot with correlation coefficient of 0.9977 for chloramphenicol. The proposed method was applied to the estimation of flurbiprofen and chloramphenicol in commercial ophthalmic formulation. The developed HPTLC method can be applied for routine analysis of flurbiprofen and chloramphenicol in the presence of their degradation products in their individual as well as combined pharmaceutical formulations. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Liability and ophthalmic drug use.

PubMed

Classé, J G

1992-01-01

Ophthalmic drug use has been an aspect of optometry for more than two decades. Although utilization of these drugs has produced significant changes in the clinical and legal responsibilities of optometrists, the liability posture of the profession has remained unaltered. Studies of malpractice claims against optometrists and ophthalmologists have demonstrated that ophthalmologists are much more likely to be charged with negligence for adverse drug reactions and that drug-related malpractice claims are not a liability issue for optometrists. Based on the experiences of both professions, this paper describes the adverse effects of common ophthalmic drugs, with emphasis on those drug reactions that have resulted in litigation.

Generalized ray tracing method for the calculation of the peripheral refraction induced by an ophthalmic lens

NASA Astrophysics Data System (ADS)

Rojo, Pilar; Royo, Santiago; Caum, Jesus; Ramírez, Jorge; Madariaga, Ines

2015-02-01

Peripheral refraction, the refractive error present outside the main direction of gaze, has lately attracted interest due to its alleged relationship with the progression of myopia. The ray tracing procedures involved in its calculation need to follow an approach different from those used in conventional ophthalmic lens design, where refractive errors are compensated only in the main direction of gaze. We present a methodology for the evaluation of the peripheral refractive error in ophthalmic lenses, adapting the conventional generalized ray tracing approach to the requirements of the evaluation of peripheral refraction. The nodal point of the eye and a retinal conjugate surface will be used to evaluate the three-dimensional distribution of refractive error around the fovea. The proposed approach enables us to calculate the three-dimensional peripheral refraction induced by any ophthalmic lens at any direction of gaze and to personalize the lens design to the requirements of the user. The complete evaluation process for a given user prescribed with a -5.76D ophthalmic lens for foveal vision is detailed, and comparative results obtained when the geometry of the lens is modified and when the central refractive error is over- or undercorrected. The methodology is also applied for an emmetropic eye to show its application for refractive errors other than myopia.

Ophthalmic preservatives: focus on polyquaternium-1.

PubMed

Rolando, Maurizio; Crider, Julie Y; Kahook, Malik Y

2011-11-01

Ophthalmic preservatives, such as polyquaternium-1 (PQ-1), are critical for the inhibition of growth of microbial contaminants in multi-dose bottles of topical medications. These antimicrobial agents must have a high efficacy against pathogenic organisms, while maintaining a favorable tolerability and safety profile. This review focuses on the ophthalmic preservative PQ-1. For comparison purposes, the most commonly used preservative, benzalkonium chloride (BAK), is also discussed. This survey focuses primarily on data collected during the past 10 years. Effective drug delivery requires more than just an active ingredient that achieves its desired biological effect on end-target tissues. In addition, drugs must be stable in the containers that they are stored in, and must possess minimal undesired local and systemic side effects that can cause patients to decrease their adherence. In addressing these concerns, specifically in topical ophthalmic drops, one must take into account the active ingredients, vehicle components and preservatives. Medications with fewer adverse effects may lead to enhanced adherence to therapy; therefore, the induction of such adverse outcomes must be considered by physicians when treating patients with chronic ocular disease. Although BAK will continue to be used in ophthalmic medications, due to its familiarity and compatibility with a broad range of topical ocular formulations, PQ-1 is certainly a viable alternative in the preservative formulary armamentarium.

The international forum of ophthalmic simulation: developing a virtual reality training curriculum for ophthalmology.

PubMed

Saleh, George M; Lamparter, Julia; Sullivan, Paul M; O'Sullivan, Fiona; Hussain, Badrul; Athanasiadis, Ioannis; Litwin, Andre S; Gillan, Stewart N

2013-06-01

To investigate the effect of a structured, supervised, cataract simulation programme on ophthalmic surgeons in their first year of training, and to evaluate the level of skill transfer. Trainees with minimal intraocular and simulator experience in their first year of ophthalmology undertook a structured, sequential, customised, virtual reality (VR) cataract training programme developed through the International Forum of Ophthalmic Simulation. A set of one-handed, bimanual, static and dynamic tasks were evaluated before and after the course and scores obtained. Statistical significance was evaluated with the Wilcoxon sign-rank test. The median precourse score of 101.50/400 (IQR 58.75-145.75) was significantly improved after completing the training programme ((postcourse score: 302/400, range: 266.25-343), p<0.001). While improvement was evident and found to be statistically significant in all parameters, greatest improvements were found for capsulorhexis and antitremor training ((Capsulorhexis: precourse score=0/100, range 0-4.5; postcourse score=81/100, range 13-87.75; p=0.002), (antitremor training: precourse score=0/100, range 0-0; postcourse score=80/100, range 60.25-91.50; p=0.001)). Structured and supervised VR training can offer a significant level of skills transfer to novice ophthalmic surgeons. VR training at the earliest stage of ophthalmic surgical training may, therefore, be of benefit.

Characterization of novel microsphere chain fiber optic tips for potential use in ophthalmic laser surgery.

PubMed

Hutchens, Thomas C; Darafsheh, Arash; Fardad, Amir; Antoszyk, Andrew N; Ying, Howard S; Astratov, Vasily N; Fried, Nathaniel M

2012-06-01

Ophthalmic surgery may benefit from use of more precise fiber delivery systems during laser surgery. Some current ophthalmic surgical techniques rely on tedious mechanical dissection of tissue layers. In this study, chains of sapphire microspheres integrated into a hollow waveguide distal tip are used for erbium:YAG laser ablation studies in contact mode with ophthalmic tissues, ex vivo. The laser's short optical penetration depth combined with the small spot diameters achieved with this fiber probe may provide more precise tissue removal. One-, three-, and five-microsphere chain structures were characterized, resulting in FWHM diameters of 67, 32, and 30 μm in air, respectively, with beam profiles comparable to simulations. Single Er:YAG pulses of 0.1 mJ and 75-μs duration produced ablation craters with average diameters of 44, 30, and 17 μm and depths of 26, 10, and 8 μm, for one-, three-, and five-sphere structures, respectively. Microsphere chains produced spatial filtering of the multimode Er:YAG laser beam and fiber, providing spot diameters not otherwise available with conventional fiber systems. Because of the extremely shallow treatment depth, compact focused beam, and contact mode operation, this probe may have potential for use in dissecting epiretinal membranes and other ophthalmic tissues without damaging adjacent retinal tissue.

iPhone 4s and iPhone 5s Imaging of the Eye.

PubMed

Jalil, Maaz; Ferenczy, Sandor R; Shields, Carol L

2017-01-01

To evaluate the technical feasibility of a consumer-grade cellular iPhone camera as an ocular imaging device compared to existing ophthalmic imaging equipment for documentation purposes. A comparison of iPhone 4s and 5s images was made with external facial images (macrophotography) using Nikon cameras, slit-lamp images (microphotography) using Zeiss photo slit-lamp camera, and fundus images (fundus photography) using RetCam II. In an analysis of six consecutive patients with ophthalmic conditions, both iPhones achieved documentation of external findings (macrophotography) using standard camera modality, tap to focus, and built-in flash. Both iPhones achieved documentation of anterior segment findings (microphotography) during slit-lamp examination through oculars. Both iPhones achieved fundus imaging using standard video modality with continuous iPhone illumination through an ophthalmic lens. Comparison to standard ophthalmic cameras, macrophotography and microphotography were excellent. In comparison to RetCam fundus photography, iPhone fundus photography revealed smaller field and was technically more difficult to obtain, but the quality was nearly similar to RetCam. iPhone versions 4s and 5s can provide excellent ophthalmic macrophotography and microphotography and adequate fundus photography. We believe that iPhone imaging could be most useful in settings where expensive, complicated, and cumbersome imaging equipment is unavailable.

Relationship between the Direction of Ophthalmic Artery Blood Flow and Ocular Microcirculation before and after Carotid Artery Stenting.

PubMed

Ishii, Masashi; Hayashi, Morito; Yagi, Fumihiko; Sato, Kenichiro; Tomita, Goji; Iwabuchi, Satoshi

2016-01-01

When internal carotid artery stenosis is accompanied by ocular ischemic syndrome, intervention is recommended to prevent irreversible visual loss. In this study, we used laser speckle flowgraphy to measure the ocular microcirculation in the optic nerve head before and after carotid artery stenting (CAS) of 40 advanced internal carotid stenosis lesions from 37 patients. The aim was to investigate the relationship between ocular microcirculation and the direction of ophthalmic artery blood flow obtained by angiography. We found that there was a significant increase in blood flow after CAS ( P = 0.003). Peak systolic velocity as an indicator of the rate of stenosis was also significantly higher in the group with retrograde/undetected flow of the ophthalmic artery than in the group with antegrade flow ( P = 0.002). In all cases where retrograde flow of the ophthalmic artery was observed before stenting, the flow changed to antegrade after stenting. Through the use of laser speckle flowgraphy, this study found that CAS can improve ocular microcirculation. Furthermore, while patients displaying retrograde flow of the ophthalmic artery before stenting have a poor prognosis, CAS corrected the flow to antegrade, suggesting that visual loss can be prevented by improving the ocular microcirculation.

Ophthalmic Manifestations of Congenital Zika Syndrome in Colombia and Venezuela

PubMed Central

Yepez, Juan B.; Murati, Felipe A.; Pettito, Michele; Peñaranda, Carlos F.; de Yepez, Jazmin; Maestre, Gladys

2017-01-01

Importance The ocular manifestations and sequelae of Zika virus infection are not well known. Recently, the World Health Organization changed the declaration of Zika as a public health emergency and designated the viral outbreak and related microcephaly clusters as a long-term program of work. This change indicates the urgent need to evaluate and document ophthalmic manifestations in patients for timely management of this disease. In addition, confirmation whether the public health problem in Brazil extends to other regions in South America is needed. Objective To report the ocular manifestations of congenital Zika syndrome with microcephaly in Colombia and Venezuela. Design, Setting, and Participants This prospective case series included 43 patients from 2 ophthalmic centers in Colombia and Venezuela who underwent evaluation from October 1, 2015, through June 30, 2016, and were clinically diagnosed with congenital Zika syndrome. Twenty patients were Hispanic; 13, African; 8, white; and 2, Native American. Interventions Ophthalmic and systemic evaluations and serologic testing were performed on all infants. Patients underwent external ocular examination and dilated ophthalmoscopy. Serologic testing ruled out toxoplasmosis, rubella, cytomegalovirus, syphilis, and human immunodeficiency virus. Main Outcomes and Measures Ophthalmic manifestations of congenital Zika syndrome. Results Of the 43 patients included in this series (28 female and 15 male), the mean (SD) age at examination was 2.1 (1.5) months. The mothers of all the children had no ophthalmic findings and did not report ocular symptoms during pregnancy. All patients had bilateral ophthalmic manifestations. Optic nerve findings included hypoplasia with the double-ring sign, pallor, and increased cup-disc ratio in 5 patients (11.6%). Macular abnormalities included mild to severe pigment mottling in 27 patients (63%) and lacunar maculopathy in 3 (6.9%). Chorioretinal scarring was present in 3 patients (7%). Eleven patients (26%) had a combination of lesions in the posterior pole. Five patients (12%) were diagnosed with congenital glaucoma, characterized by the clinical triad of epiphora, photophobia, and blepharospasm; increased intraocular pressure; corneal clouding at birth; and buphthalmos. These data reveal that 12% (95% CI, 5%-24%) of cases of congenital Zika with microcephaly had anterior segment abnormalities and 88% (95% CI, 76%-94%) had important macular and optic nerve abnormalities. The visual sequelae of these ophthalmic manifestations remain unknown. Conclusions and Relevance Congenital Zika syndrome in the current study had severe ocular abnormalities, and all patients had bilateral involvement. Ocular findings were focal macular pigment mottling, chorioretinal atrophy with a predilection for the macular area, congenital glaucoma and optical nerve hypoplasia, and optic disc abnormalities. Ophthalmic examination is recommended in patients with congenital Zika syndrome. PMID:28418539

Analysis of pilocarpine and its trans epimer, isopilocarpine, by capillary electrophoresis.

PubMed

Baeyens, W; Weiss, G; Van Der Weken, G; Van Den Bossche, W

1993-05-28

Capillary zone electrophoresis was used for the separation of pilocarpine from its epimer, isopilocarpine, using coated fused-silica capillaries of 20 cm x 25 microm I.D., 8 kV running voltage, migration buffer of 0.1 M sodium dihydrogenphosphate pH 8, detection at 217 nm and injection by electromigration. Injections of aqueous, acid and basic solutions were compared. Linearity of the signal for pilocarpine hydrochloride up to 200 microg ml(-1) in 0.05 M hydrochloric acid was obtained, using naphazoline nitrate as internal standard. Optimization of migration buffer pH using coated silica capillaries of 50 cm x 50 microm I.D. showed that at pH 6.9 pilocarpine can be separated from ++isopilocarpine. Inclusion of beta-cyclodextrin in the buffer allows full baseline separation of both epimers. The method was applied to the analysis of a commercial ophthalmic pilocarpine solution.

Toxic epitheliopathy from a single application of preservative free oxybuprocaine (0.4%) in a patient with Sjogren's syndrome.

PubMed

Ansari, Humaira; Weinberg, Laurence; Spencer, Narelle

2013-09-13

Topical ocular anaesthetic agents are frequently used for ophthalmic diagnosis and surgery. While corneal complications following long-term use or misuse of local anaesthetic solutions have been described, toxic epitheliopathy after a single application of six drops of preservative free oxybuprocaine is rare. In order to increase the awareness of this ocular complication, we report such a case in a patient with Sjogren's syndrome who presented for elective cataract surgery. We outline the mechanisms proposed to explain the ocular toxic effects of oxybuprocaine and discuss the management principles in preventing this complication in the context of Sjogren's syndrome.

Toxic epitheliopathy from a single application of preservative free oxybuprocaine (0.4%) in a patient with Sjogren's syndrome

PubMed Central

Ansari, Humaira; Weinberg, Laurence; Spencer, Narelle

2013-01-01

Topical ocular anaesthetic agents are frequently used for ophthalmic diagnosis and surgery. While corneal complications following long-term use or misuse of local anaesthetic solutions have been described, toxic epitheliopathy after a single application of six drops of preservative free oxybuprocaine is rare. In order to increase the awareness of this ocular complication, we report such a case in a patient with Sjogren's syndrome who presented for elective cataract surgery. We outline the mechanisms proposed to explain the ocular toxic effects of oxybuprocaine and discuss the management principles in preventing this complication in the context of Sjogren's syndrome. PMID:24038291

Laponite as carrier for controlled in vitro delivery of dexamethasone in vitreous humor models.

PubMed

Fraile, José M; Garcia-Martin, Elena; Gil, Cristina; Mayoral, José A; Pablo, Luis E; Polo, Vicente; Prieto, Esther; Vispe, Eugenio

2016-11-01

Laponite clay is able to retain dexamethasone by simple physisorption, presumably accomplished by hydrogen bonding formation and/or complexation with sodium counterions, as shown by solid state NMR. The physisorption can be somehow modulated by changing the solvent in the adsorption process. This simple system is able to deliver dexamethasone in a controlled manner to solutions used as models for vitreous humor. The proven biocompatibility of laponite as well as its transparency in the gel state, together with the simplicity of the preparation method, makes this system suitable for future in vivo tests of ophthalmic treatment. Copyright © 2016 Elsevier B.V. All rights reserved.

Ocular flora and their antibiotic susceptibility in patients having cataract surgery in Italy.

PubMed

Papa, Vincenzo; Blanco, Anna Rita; Santocono, Marcello

2016-09-01

To characterize the ocular flora in a consecutive group of patients having cataract surgery and to determine the antibiotic susceptibility profile of isolates to several ophthalmic antibiotics. Hospital Di Stefano, Catania, Italy. Observational case series. Conjunctival and eyelid cultures from patients were obtained 14 days before surgery and, if positive, repeated the day of the surgery. Antimicrobial susceptibility for aminoglycosides (netilmicin and tobramycin), fluoroquinolones (ofloxacin, levofloxacin, and moxifloxacin), chloramphenicol, and azithromycin was tested using the Kirby-Bauer disk diffusion method. Susceptibility was also tested for oxacillin, cefuroxime, and vancomycin. All positive patients received a 2-day preoperative course of 3 mg/mL netilmicin ophthalmic solution 4 times a day. The recovery rate of microorganisms after antibiotic treatment compared with baseline was calculated. One hundred twenty consecutive patients were included in the study. Cultures were positive in 72.5% of patients; 131 isolates, mainly gram-positive, were identified. Staphylococcus epidermidis (58.0%) and Staphylococcus aureus (15.3%) were the most frequently isolated microorganisms. Methicillin-resistant staphylococci accounted for 3.8% of S epidermidis and 20.0% of S aureus. A high in vitro susceptibility (>90%) for all isolates, including multiresistant coagulase-negative Staphylococcus, was obtained for netilmicin, vancomycin, and cefuroxime. The recovery rate of isolates before surgery was reduced by 93.9% (P < .001). Conjunctival and lid margin isolates were sensitive to netilmicin, vancomycin, and cefuroxime. Microorganisms were less susceptible to other ophthalmic antibiotics, with the exception of moxifloxacin. A 2-day preoperative course with topical netilmicin reduced most bacteria identified on the conjunctiva and eyelids. Dr. Papa and Ms. Blanco are employees of Società Industria Farmaceutica Italiana SpA. Dr. Santocono has no financial or proprietary interest in any material or method mentioned. Copyright © 2016 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

Scientific publications in ophthalmic journals from China and other top-ranking countries: a 12-year review of the literature.

PubMed

Huang, Wenbin; Wang, Wei; Zhan, Jiao; Zhou, Minwen; Chen, Shida; Zhang, Xiulan

2013-06-26

Eye diseases with increasing mortality are common health problems that affect people of all ages and demographic backgrounds. In this study, we study the publication characteristics in international ophthalmic journals of the US, the UK, Germany, Australia, Japan, and China. Articles published in 53 ophthalmic journals from 2000 to 2011 were retrieved from the PubMed database. We recorded the number of articles published each year, analyzed the publication type, and evaluated the accumulated and average impact factors (IFs), and the distribution of articles in ophthalmic journals in relation to IFs. The characteristics of publication outputs from China and other top-ranking countries were compared. The total number of articles increased significantly during the past 12 years, with an increase of 51.0%. The growth in the annual number of articles from the US, the UK, Australia, and China showed a significantly positive trend. Publications from the US exceeded those from any other country and had the highest IFs, largest number of total citations of articles, and the most articles published in leading ophthalmic journals. During the past 12 years, China contributed 3.5% of the total publications, and the number of Chinese articles showed a more than 6-fold increase (from 99 to 605, R2 =0.947, P<0.001). The numbers of IFs and citations of articles originating in China were mostly lower than for other top-ranking counties. Research on ophthalmic journals has maintained an upward growing trend from 2000 to 2011. Chinese ophthalmology research has developed rapidly, but the gap still exists between China and other top-ranking countries for the advanced level of research.

Rescue Sedation With Intranasal Dexmedetomidine for Pediatric Ophthalmic Examination After Chloral Hydrate Failure: A Randomized, Controlled Trial.

PubMed

Gan, Xiaoliang; Lin, Haotian; Chen, Jingjing; Lin, Zhuoling; Lin, Yiquan; Chen, Weirong

2016-06-01

It is a challenge to rescue ophthalmology examinations performed in children in the sedation room after initial chloral hydrate failure. Intranasal dexmedetomidine can be used in rescue sedation in children undergoing computed tomography. The present study aimed to assess the efficacy and tolerability of intranasal dexmedetomidine use in children undergoing ophthalmic examination after chloral hydrate failure. Sixty uncooperative pediatric patients with cataract (aged 5-36 months; weight, 7-15 kg) presented for follow-up ophthalmic examination. Patients who experienced chloral hydrate failure were randomized to 1 of 2 groups to receive intranasal dexmedetomidine 1 or 2 μg/kg for rescue sedation. Each group contained 30 patients. The primary outcome was the rate of a successful ophthalmic examination. Secondary outcomes included sedation onset time, recovery time, duration of examination, discharge time, and adverse events, including percentage of heart rate reduction, respiratory depression, vomiting, and postsedative agitation. A successful ophthalmic examination was achieved in 93.3% (28/30) of patients in the 2-μg/kg dose group and in 66.7% (20/30) of patients in the 1-μg/kg dose group (P = 0.021). The onset time, recovery time, and discharge time did not significantly differ between the 2 groups. None of the patients required clinical intervention due to heart rate reduction, and none of the patients in either group experienced vomiting, respiratory depression, or agitation after the administration of dexmedetomidine. In children undergoing ophthalmic examination, intranasal dexmedetomidine can be administered in the sedation room for rescue sedation after chloral hydrate failure, with the 2-μg/kg dose being more efficacious than the 1-μg/kg dose, as measured by success rate. ClinicalTrials.gov identifier: NCT02077712. Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.

Ophthalmic gels: Past, present and future.

PubMed

Al-Kinani, Ali A; Zidan, Ghada; Elsaid, Naba; Seyfoddin, Ali; Alani, Adam W G; Alany, Raid G

2018-02-15

Aqueous gels formulated using hydrophilic polymers (hydrogels) along with those based on stimuli responsive polymers (in situ gelling or gel forming systems) continue to attract increasing interest for various eye health-related applications. They allow the incorporation of a variety of ophthalmic pharmaceuticals to achieve therapeutic levels of drugs and bioactives at target ocular sites. The integration of sophisticated drug delivery technologies such as nanotechnology-based ones with intelligent and environment responsive systems can extend current treatment duration to provide more clinically relevant time courses (weeks and months instead of hours and days) which will inevitably reduce dose frequency, increase patient compliance and improve clinical outcomes. Novel applications and design of contact lenses and intracanalicular delivery devices along with the move towards integrating gels into various drug delivery devices like intraocular pumps, injections and implants has the potential to reduce comorbidities caused by glaucoma, corneal keratopathy, cataract, diabetic retinopathies and age-related macular degeneration. This review describes ophthalmic gelling systems with emphasis on mechanism of gel formation and application in ophthalmology. It provides a critical appraisal of the techniques and methods used in the characterization of ophthalmic preformed gels and in situ gelling systems along with a thorough insight into the safety and biocompatibility of these systems. Newly developed ophthalmic gels, hydrogels, preformed gels and in situ gelling systems including the latest in the area of stimuli responsive gels, molecularly imprinted gels, nanogels, 3D printed hydrogels; 3D printed devices comprising ophthalmic gels are covered. Finally, new applications of gels in the production of artificial corneas, corneal wound healing and hydrogel contact lenses are described. Copyright © 2017 Elsevier B.V. All rights reserved.

In Vivo Effects of Preservative-free and Preserved Prostaglandin Analogs: Mouse Ocular Surface Study.

PubMed

Kim, Jee Hyun; Kim, Eun Joo; Kim, Yeoun-Hee; Kim, Yong Il; Lee, Se-Hyung; Jung, Jae-Chang; Lee, Kyoo Won; Park, Young Jeung

2015-08-01

Chronic use of topical hypotensive agents induces several side effects caused by preservatives. The purpose of this study was to evaluate the effects of prostaglandin analogs with varying concentrations of benzalkonium chloride (BAC), preservative-free (PF), and alternative preservatives on mouse corneal tissue. Thirty-five, 8- to 10-week-old female C57BL/6 mice (five mice for each group) were used for this study. To the control group, we applied normal saline, and to each drug-treated group we applied 0.02% BAC, bimatoprost 0.01% (with BAC 0.02%), latanoprost 0.005% (with BAC 0.02%), travoprost 0.004% (with 0.001% polyquad) or tafluprost 0.0015% with/without 0.001% BAC, once a day (9 p.m.) for 4 weeks. Corneal fluorescein staining was evaluated in all groups. After harvest, the corneal tissues were embedded in paraffin and then Hematoxylin-Eosin stain was performed for histopathological examination. Immunofluorescence staining was done against TNF-α, IL-6, HLA DR, pJNK, and pAkt. In corneal fluorescein staining, severe punctate epithelial keratitis was seen in the groups of 0.02% BAC, 0.02% BAC containing bimatoprost 0.01% and latanoprost 0.005%. The surface desquamation, irregular surface, loss of cell borders, anisocytosis and stromal shrinkage were observed in the groups of BAC-containing eye drops. Moreover, the groups treated with BAC-containing eye drops have high inflammatory markers, significantly decreased cell viability-related signal, pAkt, and higher apoptosis-inducing signal, pJNK, than the control group. On the other hand, travoprost 0.004% and PF tafluprost 0.0015% have less cellular morphologic changes, lower inflammation, and higher cellular viability than BAC-containing formulations. Corneal damage, increased inflammation and apoptosis and low cell viability were observed in BAC-containing groups. PF or alternatively preserved glaucoma medications seem to be a reasonable and viable alternative to those preserved with BAC.

In Vivo Effects of Preservative-free and Preserved Prostaglandin Analogs: Mouse Ocular Surface Study

PubMed Central

Kim, Jee Hyun; Kim, Eun Joo; Kim, Yeoun-Hee; Kim, Yong Il; Lee, Se-Hyung; Jung, Jae-Chang; Lee, Kyoo Won

2015-01-01

Purpose Chronic use of topical hypotensive agents induces several side effects caused by preservatives. The purpose of this study was to evaluate the effects of prostaglandin analogs with varying concentrations of benzalkonium chloride (BAC), preservative-free (PF), and alternative preservatives on mouse corneal tissue. Methods Thirty-five, 8- to 10-week-old female C57BL/6 mice (five mice for each group) were used for this study. To the control group, we applied normal saline, and to each drug-treated group we applied 0.02% BAC, bimatoprost 0.01% (with BAC 0.02%), latanoprost 0.005% (with BAC 0.02%), travoprost 0.004% (with 0.001% polyquad) or tafluprost 0.0015% with/without 0.001% BAC, once a day (9 p.m.) for 4 weeks. Corneal fluorescein staining was evaluated in all groups. After harvest, the corneal tissues were embedded in paraffin and then Hematoxylin-Eosin stain was performed for histopathological examination. Immunofluorescence staining was done against TNF-α, IL-6, HLA DR, pJNK, and pAkt. Results In corneal fluorescein staining, severe punctate epithelial keratitis was seen in the groups of 0.02% BAC, 0.02% BAC containing bimatoprost 0.01% and latanoprost 0.005%. The surface desquamation, irregular surface, loss of cell borders, anisocytosis and stromal shrinkage were observed in the groups of BAC-containing eye drops. Moreover, the groups treated with BAC-containing eye drops have high inflammatory markers, significantly decreased cell viability-related signal, pAkt, and higher apoptosis-inducing signal, pJNK, than the control group. On the other hand, travoprost 0.004% and PF tafluprost 0.0015% have less cellular morphologic changes, lower inflammation, and higher cellular viability than BAC-containing formulations. Conclusions Corneal damage, increased inflammation and apoptosis and low cell viability were observed in BAC-containing groups. PF or alternatively preserved glaucoma medications seem to be a reasonable and viable alternative to those preserved with BAC. PMID:26240512

Mapping Opthalmic Terms to a Standardized Vocabulary.

ERIC Educational Resources Information Center

Patrick, Timothy B.; Reid, John C.; Sievert, MaryEllen; Popescu, Mihail; Gigantelli, James W.; Shelton, Mark E.; Schiffman, Jade S.

2000-01-01

Describes work by the American Academy of Ophthalmology (AAO) to expand the standardized vocabulary, Systematized Nomenclature of Medicine (SNOMED), to accommodate a definitive ophthalmic standardized vocabulary. Mapped a practice-based clinical ophthalmic vocabulary to SNOMED and other vocabularies in the Metathesaurus of the Unified Medical…

76 FR 42157 - Small Business Size Standards: Waiver of the Nonmanufacturer Rule

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-18

... (Ophthalmic Instruments, Equipment, and Supplies), under the North American Industry Classification System..., Service-Disabled Veteran- Owned (SDVO) small businesses, Participants in SBA's 8(a) Business Development..., Equipment, and Supplies), under NAICS code 339115 (Ophthalmic Goods Manufacturing). In response, on April 27...

The impact of the European Working Time Regulations on Ophthalmic Specialist Training--a national trainee survey.

PubMed

O'Gallagher, M K; Lewis, G; Mercieca, K; Moutray, T

2013-01-01

To assess ophthalmic trainees' perspective of the impact of the European Working Time Regulations (EWTR) on their training. All trainees in ophthalmology in the UK were emailed a link to an electronic survey asking about their experiences of the EWTR. 324 trainees (46% of those invited) responded to the survey. 44.4% of trainees reported that their posts were compliant with the EWTR. 40.7% felt that training had been adversely affected. 49.1% thought that ophthalmic trainees should opt out of the EWTR to work more than 48 h per week, with 57 the mean number of hours suggested appropriate. Many ophthalmic trainees in the United Kingdom are working in rotas which are not compliant with the European Working Time Directive. Many trainees feel that implementation of the EWTD has had a negative effect on training and feel it would be acceptable to work a higher number of hours per week. Copyright © 2013 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.

Modulation of Vasomotive Activity in Rabbit External Ophthalmic Artery by Neuropeptides

PubMed Central

Delgado, Esmeralda Sofia Costa; Marques-Neves, Carlos; Rocha, Maria Isabel Sousa; Sales-Luís, José Paulo Pacheco; Silva-Carvalho, Luís Filipe

2012-01-01

Purpose. To investigate the vasomotive activity upon the external ophthalmic artery of vasointestinal peptide (VIP) and neuropeptide Y (NPY) using a previously developed model. Methods. Isolated rabbit eyes (n = 12) were perfused in situ with tyrode through the external ophthalmic artery. Effects of intra-arterial injections of NPY 200 μg/ml (Group A; n = 6) and VIP 200 μg/ml (Group B; n = 6) on the recorded pressure were obtained. For statistical analysis, Student's paired t-test and Fast Fourier Transform were used. Results. Spontaneous oscillations were observed before any drug administration in the 12 rabbit models. NPY produced an increase in total vascular resistance and a higher frequency and amplitude of oscillations, while VIP evoked the opposite effects. Conclusions. This study provides evidence of vasomotion in basal conditions in rabbit external ophthalmic artery. Concerning drug effects, NPY increased arterial resistance and enhanced vasomotion while VIP produced opposite effects which demonstrates their profound influence in arterial vasomotion. PMID:22496962

Readability assessment of online ophthalmic patient information.

PubMed

Edmunds, Matthew R; Barry, Robert J; Denniston, Alastair K

2013-12-01

Patients increasingly use the Internet to access information related to their disease, but poor health literacy is known to impact negatively on medical outcomes. Multiple agencies have recommended that patient-oriented literature be written at a fourth- to sixth-grade (9-12 years of age) reading level to assist understanding. The readability of online patient-oriented materials related to ophthalmic diagnoses is not yet known. To assess the readability of online literature specifically for a range of ophthalmic conditions. Body text of the top 10 patient-oriented websites for 16 different ophthalmic diagnoses, covering the full range of ophthalmic subspecialties, was analyzed for readability, source (United Kingdom vs non-United Kingdom, not for profit vs commercial), and appropriateness for sight-impaired readers. Four validated readability formulas were used: Flesch Reading Ease Score (FRES), Flesch-Kincaid Grade Level (FKGL), Simple Measure of Gobbledygook (SMOG), and Gunning Fog Index (GFOG). Data were compared with the Mann-Whitney test (for 2 groups) and Kruskal-Wallis test (for more than 2 groups) and correlation was assessed by the Spearman r. None of the 160 webpages had readability scores within published guidelines, with 83% assessed as being of "difficult" readability. Not-for-profit webpages were of significantly greater length than commercial webpages (P = .02) and UK-based webpages had slightly superior readability scores compared with those of non-UK webpages (P = .004 to P < .001, depending on the readability formula used). Of all webpages evaluated, only 34% included facility to adjust text size to assist visually impaired readers. To our knowledge, this is the first study to assess readability of patient-focused webpages specifically for a range of ophthalmic diagnoses. In keeping with previous studies in other medical conditions, we determined that readability scores were inferior to those recommended, irrespective of the measure used. Although readability is only one aspect of how well a patient-oriented webpage may be comprehended, we recommend the use of readability scoring when producing such resources in the future. Minimum readability policies and inclusion of facilities within webpages to maximize viewing potential for visually impaired readers are important to ensure that online ophthalmic patient information is accessible to the broadest audience possible.

The gaseous messenger carbon monoxide is released from the eye into the ophthalmic venous blood depending on the intensity of sunlight.

PubMed

Koziorowski, M; Stefańczyk-Krzymowska, S; Tabecka-Lonczyńska, A; Gilun, P; Kamiński, M

2012-01-01

Circadian and seasonal rhythms in daylight affect many physiological processes. In the eye, energy of intense visible light not only initiates a well-studied neural reaction in the retina that modulates the secretory function of the hypothalamus and pineal gland, but also activates the heme oxygenase (HO) to produce carbon monoxide (CO). This study was designed to determine whether the concentration of carbon monoxide (CO) in the ophthalmic venous blood changes depending on the phase of the day and differing extremely light intensity seasons: summer and winter. The concentration of CO in the venous blood flowing out from the nasal cavity, where heme oxygenase (HO) is expressed, but no photoreceptors, was used as a control. Sixteen mature males of a wild boar and pig crossbreed were used for this study. Samples of ophthalmic and nasal venous blood and systemic arterial and venous blood were collected repeatedly for two consecutive days during the longest days of the summer and the shortest days of the winter. The concentrations of CO in blood samples was measured using a standard addition method. During the longest days of the summer the concentration of CO in ophthalmic venous blood averaged 3.32 ± 0.71 and 3.43 ± 0.8 nmol/ml in the morning and afternoon, respectively, and was significantly higher than in the night averaging 0.89 ± 0.12 nmol/ml (p<0.001). During the shortest day of the winter CO concentration in ophthalmic venous blood was 1.11 ± 0.10 and 1.13 ± 0.14 nmol/ml during the light and nocturnal phase, respectively, and did not differ between phases, but was lower than in the light phase of the summer (p<0.01). The CO concentration in the control nasal venous blood did not differ between seasons and day phases and was lower than in ophthalmic venous blood during the summer (p<0.01) and winter (p<0.05). The results indicate that the gaseous messenger carbon monoxide is released from the eye into the ophthalmic venous blood depending on the intensity of sunlight.

Quantitative precorneal disposition of topically applied pilocarpine nitrate in rabbit eyes.

PubMed

Patton, T F; Robinson, J R

1976-09-01

The present study was designed to quantitate the influence of several precorneal factors on the disposition of topically applied ophthalmic drugs. With tritiated pilocarpine nitrate methodology was developed for in vivo assessment of the relative contribution of tear turnover, instilled solution drainage, and nonproductive absorption to the loss of drug from the precorneal area. Studies were conducted in both awake and anesthetized rabbits whose drainage ducts were either unobstructed or plugged, and the loss of drug was monitored directly from the precorneal area or as appearance in the aqueous humor. By selective variation in experimental conditions, the influence of tear turnover, instilled solution drainage, and nonproductive absorption on ocular drug bioavailability was separately studied and quantitated. Instilled solution drainage was by far the largest contributing factor in the loss of drug from the precorneal area of the eye and, in the range of instilled volumes normally employed, tear turnover played a relatively minor role in drug loss. Compared to the cornea, precorneal tissue other than the cornea has a considerably greater surface area and thus is a potentially signifanct route for drug loss. However, under normal circumstances, loss by this route was minimal as compared to loss via instilled solution drainage.

Treatment of neuro-ophthalmic sarcoidosis.

PubMed

Frohman, Larry P

2015-03-01

Because of the rarity of neuro-ophthalmic sarcoidosis, there are no therapeutic guidelines based on evidence-based medicine for this disorder. Review of literature combined with personal experience. Corticosteroids are the preferred initial therapy for neuro-ophthalmic sarcoidosis. If patients cannot tolerate the requisite dose of corticosteroid needed to control their disease, or if corticosteroids fail to adequately control the disease process, the choices of a second agent are based on the consideration of rapidity of clinical response and the safety profile. Although methotrexate and mycophenolate mofetil are the medications that are often selected after corticosteroid failure, more rapidly acting agents that have been used are infliximab and intravenous cyclophosphamide.

Transarterial Embolization of a Spontaneous Intraorbital Arteriovenous Fistula With n-BCA Glue.

PubMed

Konstas, Angelos A; Rootman, Daniel B; Quiros, Peter A; Ross, Ian B

Arteriovenous fistulae of the orbit are exceedingly rare. They are high-flow vascular malformations involving a fistula from the ophthalmic artery to one of the draining ophthalmic veins. Presenting symptoms can mimic those of carotid cavernous fistulae or of ophthalmic venous varices, and include diplopia, proptosis, chemosis, decreased visual acuity, and retro-orbital pain. Very few case reports are published on the treatment of this aggressive vascular malformation, and they uniformly describe techniques involving a transvenous access for the embolization of the fistula. To the best of authors' knowledge, they report the first case of transarterial embolization of an intraorbital AVF.

Sustained release ophthalmic formulations of pilocarpine.

PubMed

Deshpande, S G; Shirolkar, S

1989-03-01

The bioavailability of drugs from conventional ophthalmic formulations is low. To optimize the therapy, sustained release ophthalmic dosage forms are warranted. Hydrogels such as sodium-carboxymethyl cellulose, hydroxypropylmethyl cellulose, Carbopol-940, Carbopol-941 and Lutrol-FC-127 increase the duration of action of various drugs. Gels containing pilocarpine were prepared and evaluated by measuring the intensity and duration of miotic response in albino rabbits. Carbopol-940 gels, being the best of those used, were studied further for the effect of its concentration and of additives (benzalkonium chloride, phenylmercuric nitrate, chlorbutol and disodium edetate), autoclaving at 121 degrees C for 30 min and irradiation with gamma rays (2.5 Mrad), on the end product.

Evidence-based emergency medicine. Update: do ophthalmic nonsteroidal anti-inflammatory drugs reduce the pain associated with simple corneal abrasion without delaying healing?

PubMed

Weaver, Christopher S; Terrell, Kevin M

2003-01-01

Some studies have suggested that ophthalmic nonsteroidal anti-inflammatory drugs (NSAIDs) decrease the pain associated with corneal abrasions without impairing healing. This evidence-based emergency medicine (EBEM) critical appraisal reviews the literature, including additional studies appearing since the publication of an earlier EBEM review in 1999. The updated search for randomized controlled trials from 1999 to 2002 complemented the previous 1966 to 1999 search. The methodologic quality of the studies was assessed. Qualitative methods were used to summarize the study results. The search identified 3 studies not included in the previously published review of ophthalmic NSAIDs, yielding a total of 5 blinded, randomized, placebo-controlled trials involving NSAIDs for corneal abrasions. The methodologic quality of the new studies was somewhat higher than that of the 2 original studies and was rated as "good" to "strong." The qualitative summary indicates that NSAIDs provide greater pain relief and improvement of other subjective symptoms when compared with placebo. However, whether the reduction of pain, as measured by visual analog pain scales, exceeds the minimal clinically significant difference is equivocal. The use of ophthalmic NSAIDs may decrease the need for sedating analgesics. Ophthalmic NSAIDs appear to be useful for decreasing pain in patients with corneal abrasions who can afford the medication and who must return to work immediately, particularly where potential opioid-induced sedation is intolerable.

NEUROSARCOIDOSIS MASQUERADING AS A CENTRAL NERVOUS SYSTEM TUMOR.

PubMed

Elia, Maxwell; Kombo, Ninani; Huang, John

2017-01-01

To report a case of neurosarcoidosis with an isolated brain lesion mimicking a low-grade glioma. A 38-year-old woman presented with 2 weeks of blurry vision in the left eye. Ophthalmic examination, visual field testing, fluorescein angiography, laboratory testing, and MRI of the brain were performed. Ophthalmic examination revealed left-sided optic nerve infiltration, and MRI of the brain demonstrated a solitary lesion in the brain. The visual symptoms and ophthalmic examination improved significantly with initiation of high-dose oral prednisone. Because the MRI appearance was concerning for malignancy, a brain biopsy was performed. Pathology demonstrated gliosis consistent with a low-grade central nervous system (CNS) glioma. One year later, after initial loss to ophthalmic follow-up, the right optic nerve became involved, and the patient was again treated successfully for presumed ocular sarcoidosis. At this time, serial neuroimaging demonstrated enlargement of the CNS lesion, prompting rebiopsy. Rebiopsy demonstrated a noncaseating granuloma, confirming the diagnosis of neurosarcoidosis. The patient was treated with 20 mg of methotrexate weekly and a prednisone taper with improvement in visual and neurologic symptoms. The authors present an unusual case of neurosarcoidosis masquerading as a CNS glioma. In cases of solitary CNS granulomas, radiographically differentiating neurosarcoidosis from a glioma can be challenging. In this case, serial ophthalmic examination identifying sequential involvement of both optic nerves helped to identify the underlying cause of the CNS disease as sarcoidosis.

Characterization of novel microsphere chain fiber optic tips for potential use in ophthalmic laser surgery

PubMed Central

Hutchens, Thomas C.; Darafsheh, Arash; Fardad, Amir; Antoszyk, Andrew N.; Ying, Howard S.; Astratov, Vasily N.

2012-01-01

Abstract. Ophthalmic surgery may benefit from use of more precise fiber delivery systems during laser surgery. Some current ophthalmic surgical techniques rely on tedious mechanical dissection of tissue layers. In this study, chains of sapphire microspheres integrated into a hollow waveguide distal tip are used for erbium:YAG laser ablation studies in contact mode with ophthalmic tissues, ex vivo. The laser’s short optical penetration depth combined with the small spot diameters achieved with this fiber probe may provide more precise tissue removal. One-, three-, and five-microsphere chain structures were characterized, resulting in FWHM diameters of 67, 32, and 30 μm in air, respectively, with beam profiles comparable to simulations. Single Er:YAG pulses of 0.1 mJ and 75-μs duration produced ablation craters with average diameters of 44, 30, and 17 μm and depths of 26, 10, and 8 μm, for one-, three-, and five-sphere structures, respectively. Microsphere chains produced spatial filtering of the multimode Er:YAG laser beam and fiber, providing spot diameters not otherwise available with conventional fiber systems. Because of the extremely shallow treatment depth, compact focused beam, and contact mode operation, this probe may have potential for use in dissecting epiretinal membranes and other ophthalmic tissues without damaging adjacent retinal tissue. PMID:22734790

iPhone 4s and iPhone 5s Imaging of the Eye

PubMed Central

Jalil, Maaz; Ferenczy, Sandor R.; Shields, Carol L.

2017-01-01

Background/Aims To evaluate the technical feasibility of a consumer-grade cellular iPhone camera as an ocular imaging device compared to existing ophthalmic imaging equipment for documentation purposes. Methods A comparison of iPhone 4s and 5s images was made with external facial images (macrophotography) using Nikon cameras, slit-lamp images (microphotography) using Zeiss photo slit-lamp camera, and fundus images (fundus photography) using RetCam II. Results In an analysis of six consecutive patients with ophthalmic conditions, both iPhones achieved documentation of external findings (macrophotography) using standard camera modality, tap to focus, and built-in flash. Both iPhones achieved documentation of anterior segment findings (microphotography) during slit-lamp examination through oculars. Both iPhones achieved fundus imaging using standard video modality with continuous iPhone illumination through an ophthalmic lens. Comparison to standard ophthalmic cameras, macrophotography and microphotography were excellent. In comparison to RetCam fundus photography, iPhone fundus photography revealed smaller field and was technically more difficult to obtain, but the quality was nearly similar to RetCam. Conclusions iPhone versions 4s and 5s can provide excellent ophthalmic macrophotography and microphotography and adequate fundus photography. We believe that iPhone imaging could be most useful in settings where expensive, complicated, and cumbersome imaging equipment is unavailable. PMID:28275604

Reduction of cytotoxicity of benzalkonium chloride and octenidine by Brilliant Blue G.

PubMed

Bartok, Melinda; Tandon, Rashmi; Alfaro-Espinoza, Gabriela; Ullrich, Matthias S; Gabel, Detlef

2015-01-01

The irritative effects of preservatives found in ophthalmologic solution, or of antiseptics used for skin disinfection is a consistent problem for the patients. The reduction of the toxic effects of these compounds is desired. Brilliant Blue G (BBG) has shown to meet the expected effect in presence of benzalkonium chloride (BAK), a well known preservative in ophthalmic solutions, and octenidine dihydrochloride (Oct), used as antiseptic in skin and wound disinfection. BBG shows a significant protective effect on human corneal epithelial (HCE) cells against BAK and Oct toxicity, increasing the cell survival up to 51 % at the highest BAK or Oct concentration tested, which is 0.01 %, both at 30 min incubation. Although BBG is described as a P2x7 receptor antagonist, other selective P2x7 receptor antagonists, OxATP (adenosine 5'-triphosphate-2',3'-dialdehyde) and DPPH (N'-(3,5-dichloropyridin-4-yl)-3-phenylpropanehydrazide), did not reduce the cytotoxicity of neither BAK nor Oct. Therefore we assume that the protective effect of BBG is not due to its action on the P2x7 receptor. Brilliant Blue R (BBR), a dye similar to BBG, was also tested for protective effect on BAK and Oct toxicity. In presence of BAK no significant protective effect was observed. Instead, with Oct a comparable protective effect was seen with that of BBG. To assure that the bacteriostatic effect is not affected by the combinations of BAK/BBG, Oct/BBG and Oct/BBR, bacterial growth inhibition was analyzed on different Gram-negative and Gram-positive bacteria. All combinations of BAK or Oct with BBG hinder growth of Gram-positive bacteria. The combinations of 0.001 % Oct and BBR above 0.025 % do not hinder the growth of B. subtilis. For Gram-negative bacteria, BBG and BBR reduce, but do not abolish, the antimicrobial effect of BAK nor of Oct. In conclusion, the addition of BBG at bacterial inhibitory concentrations is suggested in the ready-to-use ophthalmic preparations and antiseptic solutions.

Reduction of cytotoxicity of benzalkonium chloride and octenidine by Brilliant Blue G

PubMed Central

Bartok, Melinda; Tandon, Rashmi; Alfaro-Espinoza, Gabriela; Ullrich, Matthias S.; Gabel, Detlef

2015-01-01

The irritative effects of preservatives found in ophthalmologic solution, or of antiseptics used for skin disinfection is a consistent problem for the patients. The reduction of the toxic effects of these compounds is desired. Brilliant Blue G (BBG) has shown to meet the expected effect in presence of benzalkonium chloride (BAK), a well known preservative in ophthalmic solutions, and octenidine dihydrochloride (Oct), used as antiseptic in skin and wound disinfection. BBG shows a significant protective effect on human corneal epithelial (HCE) cells against BAK and Oct toxicity, increasing the cell survival up to 51 % at the highest BAK or Oct concentration tested, which is 0.01 %, both at 30 min incubation. Although BBG is described as a P2x7 receptor antagonist, other selective P2x7 receptor antagonists, OxATP (adenosine 5’-triphosphate-2’,3’-dialdehyde) and DPPH (N’-(3,5-dichloropyridin-4-yl)-3-phenylpropanehydrazide), did not reduce the cytotoxicity of neither BAK nor Oct. Therefore we assume that the protective effect of BBG is not due to its action on the P2x7 receptor. Brilliant Blue R (BBR), a dye similar to BBG, was also tested for protective effect on BAK and Oct toxicity. In presence of BAK no significant protective effect was observed. Instead, with Oct a comparable protective effect was seen with that of BBG. To assure that the bacteriostatic effect is not affected by the combinations of BAK/BBG, Oct/BBG and Oct/BBR, bacterial growth inhibition was analyzed on different Gram-negative and Gram-positive bacteria. All combinations of BAK or Oct with BBG hinder growth of Gram-positive bacteria. The combinations of 0.001 % Oct and BBR above 0.025 % do not hinder the growth of B. subtilis. For Gram-negative bacteria, BBG and BBR reduce, but do not abolish, the antimicrobial effect of BAK nor of Oct. In conclusion, the addition of BBG at bacterial inhibitory concentrations is suggested in the ready-to-use ophthalmic preparations and antiseptic solutions. PMID:26417355

21 CFR 524.155 - Bacitracin zinc-polymyxin B sulfate-neomycin sulfate-hydrocortisone or hydrocortisone acetate...

Code of Federal Regulations, 2013 CFR

2013-04-01

... sulfate-hydrocortisone or hydrocortisone acetate ophthalmic ointment. 524.155 Section 524.155 Food and... zinc-polymyxin B sulfate-neomycin sulfate-hydrocortisone or hydrocortisone acetate ophthalmic ointment... hydrocortisone. (2) To 043264; each gram of ointment contains 400 units of bacitracin zinc, 10,000 units of...

21 CFR 524.155 - Bacitracin zinc-polymyxin B sulfate-neomycin sulfate-hydrocortisone or hydrocortisone acetate...

Code of Federal Regulations, 2010 CFR

2010-04-01

... sulfate-hydrocortisone or hydrocortisone acetate ophthalmic ointment. 524.155 Section 524.155 Food and... zinc-polymyxin B sulfate-neomycin sulfate-hydrocortisone or hydrocortisone acetate ophthalmic ointment... hydrocortisone. (2) To 025463; each gram of ointment contains 400 units of bacitracin zinc, 10,000 units of...

21 CFR 524.155 - Bacitracin zinc-polymyxin B sulfate-neomycin sulfate-hydrocortisone or hydrocortisone acetate...

Code of Federal Regulations, 2012 CFR

2012-04-01

... sulfate-hydrocortisone or hydrocortisone acetate ophthalmic ointment. 524.155 Section 524.155 Food and... zinc-polymyxin B sulfate-neomycin sulfate-hydrocortisone or hydrocortisone acetate ophthalmic ointment... hydrocortisone. (2) To 025463; each gram of ointment contains 400 units of bacitracin zinc, 10,000 units of...

21 CFR 524.155 - Bacitracin zinc-polymyxin B sulfate-neomycin sulfate-hydrocortisone or hydrocortisone acetate...

Code of Federal Regulations, 2011 CFR

2011-04-01

... sulfate-hydrocortisone or hydrocortisone acetate ophthalmic ointment. 524.155 Section 524.155 Food and... zinc-polymyxin B sulfate-neomycin sulfate-hydrocortisone or hydrocortisone acetate ophthalmic ointment... hydrocortisone. (2) To 025463; each gram of ointment contains 400 units of bacitracin zinc, 10,000 units of...

21 CFR 524.1200a - Kanamycin ophthalmic ointment.

Code of Federal Regulations, 2012 CFR

2012-04-01

... prophylactic in traumatic conditions, removal of foreign bodies, and intraocular surgery. Apply a thin film to... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Kanamycin ophthalmic ointment. 524.1200a Section 524.1200a Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

21 CFR 524.1200a - Kanamycin ophthalmic ointment.

Code of Federal Regulations, 2014 CFR

2014-04-01

... kanamycin. For prophylaxis in traumatic conditions, removal of foreign bodies, and intraocular surgery. (3... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Kanamycin ophthalmic ointment. 524.1200a Section 524.1200a Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

21 CFR 524.1200a - Kanamycin ophthalmic ointment.

Code of Federal Regulations, 2013 CFR

2013-04-01

... prophylactic in traumatic conditions, removal of foreign bodies, and intraocular surgery. Apply a thin film to... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Kanamycin ophthalmic ointment. 524.1200a Section 524.1200a Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

76 FR 30176 - Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-24

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration... Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee...

10 CFR 35.491 - Training for ophthalmic use of strontium-90.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Training for ophthalmic use of strontium-90. 35.491 Section 35.491 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Manual Brachytherapy... radiotherapy. The training must include— (i) Radiation physics and instrumentation; (ii) Radiation protection...

10 CFR 35.491 - Training for ophthalmic use of strontium-90.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Training for ophthalmic use of strontium-90. 35.491 Section 35.491 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Manual Brachytherapy... radiotherapy. The training must include— (i) Radiation physics and instrumentation; (ii) Radiation protection...

10 CFR 35.491 - Training for ophthalmic use of strontium-90.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false Training for ophthalmic use of strontium-90. 35.491 Section 35.491 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Manual Brachytherapy... radiotherapy. The training must include— (i) Radiation physics and instrumentation; (ii) Radiation protection...

10 CFR 35.491 - Training for ophthalmic use of strontium-90.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false Training for ophthalmic use of strontium-90. 35.491 Section 35.491 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Manual Brachytherapy... radiotherapy. The training must include— (i) Radiation physics and instrumentation; (ii) Radiation protection...

Initiating an ophthalmic laser program for VA outpatients.

PubMed

Newcomb, R D

1995-08-01

Administrative and clinical considerations for the establishment of an ophthalmic laser program at a VA Outpatient Clinic are discussed. Outcomes of the first 320 patients treated over a 3-year period of time are presented. The program is evaluated from the perspectives of patient care, safety, maintenance, education, and economics.

New Zealand health reforms: effect on ophthalmic practice.

PubMed

Raynel, S; Reynolds, H

1999-01-01

Are specialized ophthalmic units with inpatient facilities going to disappear in the New Zealand public health system? We have entered the era of cost containment, business methodologies, bench marking, day case surgery, and technologic advances. The dilemma for nursing is maintenance of a skill base with dwindling clinical practice areas.

21 CFR 886.1750 - Skiascopic rack.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Skiascopic rack. 886.1750 Section 886.1750 Food... DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1750 Skiascopic rack. (a) Identification. A skiascopic rack is a device that is a rack and a set of attached ophthalmic lenses of various dioptric strengths...

76 FR 72619 - Ophthalmic and Topical Dosage Form New Animal Drugs; Eprinomectin

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-25

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 524 [Docket No. FDA-2011-N-0003] Ophthalmic and Topical Dosage Form New Animal Drugs; Eprinomectin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: The Food and Drug...

New 223-nm excimer laser surgical system for photorefractive keratectomy

NASA Astrophysics Data System (ADS)

Bagaev, Sergei N.; Razhev, Alexander M.; Zhupikov, Andrey A.

1999-02-01

The using of KrCl (223 nm) excimer laser in ophthalmic devices for Photorefractive Keratectomy (PRK) and phototherapeutic Keratectomy (PTK) is offered. The structure and functions of a new surgical UV ophthalmic laser systems Medilex using ArF (193 nm) or KrCl (223 nm) excimer laser for corneal surgery are presented. The systems Medilex with the new optical delivery system is used for photoablative reprofiling of the cornea to correct refraction errors (myopia, hyperopia and astigmatism) and to treat a corneal pathologies. The use of the 223 nanometer laser is proposed to have advantages over the 193 nanometer laser. The results of application of the ophthalmic excimer laser systems Medilex for treatment of myopia are presented.

Use of ECT in the presence of acute bilateral posterior vitreous detachmanet.

PubMed

Taye, Tesema; Dobranici, Letitia; Fisher, Mark; Cullum, Sarah

2018-04-01

We describe a case of acute bilateral posterior vitreous detachment (PVD) in a 71-year-old female, which developed during a course of electroconvulsive therapy (ECT) for treatment-resistant depression. The risks and benefits of continuing ECT were assessed and the patient completed the full course of 16 ECT treatments without further ophthalmic complications. As the incidence of PVD increases with age, and ECT is used more frequently in elderly people with depression, we recommend paying attention to ophthalmic symptoms as part of the routine clinical monitoring of ECT side effects. If ophthalmic symptoms occur, the risks and benefits of ECT need to be weighed up including consultation with an ophthalmologist.

Colored floaters as a manifestation of digoxin toxicity.

PubMed

Shi, Lynn; Sun, Linus D; Odel, Jeffrey G

2018-06-01

Since its report in one patient more than 70 years ago, digitalis-induced colored muscae volitantes have not surfaced again in the literature. We report here a case of digoxin induced colored floaters. An 89-year-old man on 0.25 mg digoxin daily developed visual hallucinations and colored floaters. He had floaters in the past but now they were in various colors including yellow, green, blue and red, though predominantly in yellow. These "weirdly" shaped little particles wiggled around as if in a viscous solution and casted shadows in his vision. He also saw geometric shapes, spirals, and cross hatch patterns of various colors that moved and undulated, especially on wallpaper. Ophthalmic examination revealed reduced visual acuity, poor color vision especially in his left eye, along with central depression on Amsler grid and Humphrey visual field in his left eye. Discontinuation of digoxin resulted in complete resolution of his visual symptoms. On subsequent ophthalmic examination, the patient's visual acuity, field testing and color vision improved and he had normal Amsler grid test results. Colored floaters may occur in patients taking cardiac glycosides but this association has not been explored. Unlike optical illusions and visual hallucinations, floaters are entoptic phenomena casting a physical shadow upon the retina and their coloring likely arise from retinal dysfunction. Colored floaters may be a more common visual phenomenon than realized.

Development of loteprednol etabonate-loaded cationic nanoemulsified in-situ ophthalmic gel for sustained delivery and enhanced ocular bioavailability.

PubMed

Patel, Nirav; Nakrani, Happy; Raval, Mihir; Sheth, Navin

2016-11-01

A novel cationic nanoemulsified in-situ ophthalmic gel of loteprednol etabonate (LE) was developed to improve the permeability and retention time of formulations for overall improvement of drug's ocular bioavability. Capryol 90 (oil phase), tween 80 (surfactant) and transcutol P (cosurfactant) was selected as formulation excipients to construct pseudoternary phase diagrams and nanoemulsion region was recognized from diagrams. Spontaneous emulsification method was used to manufacture LE nanoemulsion and it was optimized using 3 2 factorial design by considering the amount of oil and the ratio of surfactant to cosurfactant (S mix ) as independent variables and evaluated for various physicochemical properties. Optimized NE was dispersed in Poloxamer 407 and 188 solution to form nanoemulsified sols that were predictable to transform into in-situ gels at corneal temperature. Drug pharmacokinetics of sterilized optimized in situ NE gel, NE-ISG2 [0.69% w/w Capryol 90, 0.99%w/w S mix (3:1), 13% Poloxamer 407, 4% w/w Poloxamer 188] and marketed formulation were assessed in rabbit aqueous humor. The in-situ gels were clear, shear thinning in nature and displayed zero-order drug release kinetics. NE-ISG2 showed the minimum ocular irritation potential and significantly (p < 0.01) higher C max and AUC (0-10 h) , delayed T max , extended mean residence time and improved (2.54-fold times) bioavailability compared to marketed formulation.

21 CFR 524.155 - Bacitracin, neomycin, polymyxin B, and hydrocortisone ophthalmic ointment.

Code of Federal Regulations, 2014 CFR

2014-04-01

... hydrocortisone ophthalmic ointment. 524.155 Section 524.155 Food and Drugs FOOD AND DRUG ADMINISTRATION... TOPICAL DOSAGE FORM NEW ANIMAL DRUGS § 524.155 Bacitracin, neomycin, polymyxin B, and hydrocortisone... sulfate, and10 mg of hydrocortisone. (b) Sponsors. See Nos. 000061 and 043264 in § 510.600(c) of this...

21 CFR 349.50 - Labeling of ophthalmic drug products.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., discard.” (3) For ophthalmic drug products containing mercury compounds used as a preservative. “This product contains (name and quantity of mercury-containing ingredient) as a preservative. Do not use this product if you are sensitive to” (select one of the following: “mercury” or “(insert name of mercury...

21 CFR 349.50 - Labeling of ophthalmic drug products.

Code of Federal Regulations, 2014 CFR

2014-04-01

..., discard.” (3) For ophthalmic drug products containing mercury compounds used as a preservative. “This product contains (name and quantity of mercury-containing ingredient) as a preservative. Do not use this product if you are sensitive to” (select one of the following: “mercury” or “(insert name of mercury...

21 CFR 349.50 - Labeling of ophthalmic drug products.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., discard.” (3) For ophthalmic drug products containing mercury compounds used as a preservative. “This product contains (name and quantity of mercury-containing ingredient) as a preservative. Do not use this product if you are sensitive to” (select one of the following: “mercury” or “(insert name of mercury...

21 CFR 349.50 - Labeling of ophthalmic drug products.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., discard.” (3) For ophthalmic drug products containing mercury compounds used as a preservative. “This product contains (name and quantity of mercury-containing ingredient) as a preservative. Do not use this product if you are sensitive to” (select one of the following: “mercury” or “(insert name of mercury...

21 CFR 349.50 - Labeling of ophthalmic drug products.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., discard.” (3) For ophthalmic drug products containing mercury compounds used as a preservative. “This product contains (name and quantity of mercury-containing ingredient) as a preservative. Do not use this product if you are sensitive to” (select one of the following: “mercury” or “(insert name of mercury...

Canine viral infections.

PubMed

Willis, A M

2000-09-01

The ophthalmic effects of viral infection are varied. With the added possibility for pathologic effects of attenuated vaccine viruses, the diagnosis of viral diseases can be a challenge. In many cases, ocular manifestations can provide added support to a presumptive diagnosis of viral disease, thereby underscoring the benefit of thorough ophthalmic examination of any animal with nonspecific signs of illness.

76 FR 71349 - Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-17

.... Contact Person: Yvette Waples, Center for Drug Evaluation and Research, Food and Drug Administration... following topics related to the use of ophthalmic drug products (products intended for use in the eye): (1... infection. FDA's Center for Drug Evaluation and Research would like the advisory committee to provide advice...

75 FR 54492 - Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin and Betamethasone Ophthalmic...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-08

..., 2010. FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for Veterinary Medicine (HFV-110... to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR... for use. For treatment of external bacterial infections of the eye (conjunctiva and cornea). (3...

Wideband Electrically-Pumped 1050 nm MEMS-Tunable VCSEL for Ophthalmic Imaging.

PubMed

John, Demis D; Burgner, Christopher B; Potsaid, Benjamin; Robertson, Martin E; Lee, Byung Kun; Choi, Woo Jhon; Cable, Alex E; Fujimoto, James G; Jayaraman, Vijaysekhar

2015-08-15

In this paper, we present a 1050 nm electrically-pumped micro-electro-mechanically-tunable vertical-cavity-surface-emitting-laser (MEMS-VCSEL) with a record dynamic tuning bandwidth of 63.8 nm, suitable for swept source optical coherence tomography (SS-OCT) imaging. These devices provide reduced cost & complexity relative to previously demonstrated optically pumped devices by obviating the need for a pump laser and associated hardware. We demonstrate ophthalmic SS-OCT imaging with the electrically-pumped MEMS-VCSEL at a 400 kHz axial scan rate for wide field imaging of the in vivo human retina over a 12 mm × 12 mm field and for OCT angiography of the macula over 6 mm × 6 mm & 3 mm × 3 mm fields to show retinal vasculature and capillary structure near the fovea. These results demonstrate the feasibility of electrically pumped MEMS-VCSELs in ophthalmic instrumentation, the largest clinical application of OCT. In addition, we estimate that the 3 dB coherence length in air is 225 meters ± 51 meters, far greater than required for ophthalmic SS-OCT and suggestive of other distance ranging applications.

Correlation of ophthalmic examination with carrier status in females potentially harboring a severe Norrie disease gene mutation.

PubMed

Khan, Arif O; Aldahmesh, Mohammed A; Meyer, Brian

2008-04-01

To correlate ophthalmic findings with carrier status for a severe Norrie disease (ND) gene mutation (C95F). Prospective interventional case series. Six potential carriers and 1 obligate carrier from a family harboring the mutation. An ophthalmologist blind to the pedigree performed a full ophthalmic examination for the 7 asymptomatic family members. A peripheral blood sample was collected from each for ND gene sequencing. Ophthalmic examination findings (with attention to the presence or absence of retinal findings) and results of ND gene sequencing. Three carriers were identified by molecular genetics, and all 3 of them had peripheral retinal abnormality. However, 3 of the 4 genetically identified noncarriers also exhibited peripheral retinal abnormality. Two of these noncarriers with retinal findings were the offspring of a confirmed noncarrier. The genetically identified noncarrier with a normal peripheral retinal examination was the daughter of an obligate carrier. The presence of peripheral retinal changes was not useful for carrier prediction in a family harboring ND. There are likely additional loci responsible for phenotypic expression.

A randomized, double-blind, safety and tolerability study to assess the ophthalmic and renal effects of tafenoquine 200 mg weekly versus placebo for 6 months in healthy volunteers.

PubMed

Leary, Kevin J; Riel, Michael A; Roy, Michael J; Cantilena, Louis R; Bi, Daoqin; Brater, D Craig; van de Pol, Corina; Pruett, Khadeeja; Kerr, Caron; Veazey, James M; Beboso, Ronnie; Ohrt, Colin

2009-08-01

A randomized, double-blind, placebo-controlled study was conducted to assess the effect of tafenoquine, 200 mg weekly for 6 months on ophthalmic and renal safety. This trial was carried out after observations in previous clinical trials that tafenoquine may be associated with the development of corneal deposits and elevations in serum creatinine. In 120 healthy volunteers who received tafenoquine or placebo in a 2:1 randomization, there was no effect on night vision or other ophthalmic indices measured. Persons taking tafenoquine also showed no difference in mean change in glomerular filtration rate (GFR, mL/s/1.73 m(2)) after 6 months of dosing, with a treatment difference of -0.061 (95% confidence interval, -0.168, 0.045), and non-inferiority margin of -0.247 mL/s/1.73 m(2). Tafenoquine was well tolerated over the course of the study. The results of this study showed no clinically significant effects of tafenoquine on ophthalmic or renal function, and support its continued development as an antimalarial drug.

Ophthalmic acid accumulation in an Escherichia coli mutant lacking the conserved pyridoxal 5'-phosphate-binding protein YggS.

PubMed

Ito, Tomokazu; Yamauchi, Ayako; Hemmi, Hisashi; Yoshimura, Tohru

2016-12-01

Escherichia coli YggS is a highly conserved pyridoxal 5'-phosphate (PLP)-binding protein whose biochemical function is currently unknown. A previous study with a yggS-deficient E. coli strain (ΔyggS) demonstrated that YggS controls l-Ile- and l-Val-metabolism by modulating 2-ketobutyrate (2-KB), l-2-aminobutyrate (l-2-AB), and/or coenzyme A (CoA) availability in a PLP-dependent fashion. In this study, we found that ΔyggS accumulates an unknown metabolite as judged by amino acid analyses. LC/MS and MS/MS analyses of the compound with propyl chloroformate derivatization, and co-chromatography analysis identified this compound as γ-l-glutamyl-l-2-aminobutyryl-glycine (ophthalmic acid), a glutathione (GSH) analogue in which the l-Cys moiety is replaced by l-2-AB. We also determine the metabolic consequence of the yggS mutation. Absence of YggS initially increases l-2-AB availability, and then causes ophthalmic acid accumulation and CoA limitation in the cell. The expression of a γ-glutamylcysteine synthetase and a glutathione synthetase in a ΔyggS background causes high-level accumulation of ophthalmic acid in the cells (∼1.2 nmol/mg cells) in a minimal synthetic medium. This opens the possibility of a first fermentative production of ophthalmic acid. Copyright © 2016 The Society for Biotechnology, Japan. Published by Elsevier B.V. All rights reserved.

Use of topical anesthetic and non-medical alternatives in welding workers regarding ophthalmic problems.

PubMed

Aslan, Lokman; Sucakli, Mustafa Haki; Bozkurt, Selim; Aslankurt, Murat; Aksoy, Adnan; Celik, Mustafa

2014-06-01

Welding workers' ophthalmic problems resulting from their professions are frequently observed in ophthalmic emergencies and can cause severe visual impairment. We aimed to investigate the use of topical anesthetic and non-medical alternatives of this population regarding ophthalmic problems in this study. The study included 204 welding workers randomly selected from a population of 1852 people who had at least one-year experience as a welding worker and who were members of a chamber of welding workers. Data were collected at face to face interviews with a questionnaire composed of questions about ophthalmic problems caused by their profession and about how they eliminated these problems. Obtained data were analyzed with SPSS. Of 204 workers, 38.7% preferred non-medical alternatives including application of potatoes (22%), dressing with tea (17%), rinsing with cold water (3.4%) and closing eyes (2%). 30.5% of the participants used topical anesthetics (72% commercial and 28% prepared in pharmacies). There was a significant relation between use of non-medical methods and topical anesthetics, and workers' education, duration of work experience and receiving training from their seniors (p < 0.05). Use of non-medical methods and topical anesthetics by welding workers was found to be associated with low-education levels and insufficient knowledge about ophthalmologic problems due their professions and their treatment. They should be provided with appropriate training for the issue and precautions should be taken to prevent people from buying drugs without a prescription.

Comparison of sedation by intranasal dexmedetomidine and oral chloral hydrate for pediatric ophthalmic examination.

PubMed

Cao, Qianzhong; Lin, Yiquan; Xie, Zhubin; Shen, Weihua; Chen, Ying; Gan, Xiaoliang; Liu, Yizhi

2017-06-01

Pediatric ophthalmic examinations can be conducted under sedation either by chloral hydrate or by dexmedetomidine. The objective was to compare the success rates and quality of ophthalmic examination of children sedated by intranasal dexmedetomidine vs oral chloral hydrate. One hundred and forty-one children aged from 3 to 36 months (5-15 kg) scheduled to ophthalmic examinations were randomly sedated by either intranasal dexmedetomidine (2 μg·kg -1 , n = 71) or oral chloral hydrate (80 mg·kg -1 , n = 70). The primary endpoint was successful sedation to complete the examinations including slit-lamp photography, tonometry, anterior segment analysis, and refractive error inspection. The secondary endpoints included quality of eye position, intraocular pressure, onset time, duration of examination, recovery time, discharge time, any side effects during examination, and within 48 h after discharge. Sixty-one children were sedated by dexmedetomidine with a success rate of 85.9%, which is significantly higher than that by chloral hydrate (64.3%) [OR 3.39, 95% CI: 1.48-7.76, P = 0.003]. Furthermore, children in the dexmedetomidine group displayed better eye position in anterior segment analysis than in chloral hydrate group median difference. All children displayed stable hemodynamics and none suffered hypoxemia in both groups. Oral chloral hydrate induced higher percentages of vomiting and altered bowel habit after discharge than dexmedetomidine. Intranasal dexmedetomidine provides more successful sedation and better quality of ophthalmic examinations than oral chloral hydrate for small children. © 2017 John Wiley & Sons Ltd.

An Analysis of Medicare Reimbursement to Ophthalmologists: Years 2012 to 2013.

PubMed

Han, Everett; Baisiwala, Shivani; Jain, Atul; Bundorf, M Kate; Pershing, Suzann

2017-10-01

To analyze trends in utilization and payment of ophthalmic services in the Medicare population for years 2012 and 2013. Retrospective, cross-sectional study. A retrospective cross-sectional observational analysis was performed using publicly available Medicare Physician and Other Supplier aggregate file and the Physician and Other Supplier Public Use File. Variables analyzed included aggregate beneficiary demographics, Medicare payments to ophthalmologists, ophthalmic medical services provided, and the most common Medicare-reimbursed ophthalmic services. In 2013, total Medicare Part B reimbursement for ophthalmology was $5.8 billion, an increase of 3.6% from the previous year. From 2012 to 2013, the total number of ophthalmology services rendered increased by 2.2%, while average dollar amount reimbursed per ophthalmic service decreased by 5.4%. The top 5 highest reimbursed services accounted for 85% of total ophthalmic Medicare payments in 2013, an 11% increase from 2012. During 2013, drug reimbursement represented 32.8% of the total Medicare payments to ophthalmologists. Ranibizumab and aflibercept alone accounted for 95% of the entire $1.9 billion in drug reimbursements ophthalmologists in 2013. Medicare Part B reimbursement for ophthalmologists was primarily driven by use of anti-vascular endothelial growth factor (anti-VEGF) injections from 2012 to 2013. Of the total drug payments to ophthalmologists, biologic anti-VEGF agents ranibizumab and aflibercept accounted for 95% of all drug reimbursement. This is in contrast to other specialties, in which drug reimbursement represented only a small portion of Medicare reimbursement. Published by Elsevier Inc.

Deep lateral wall orbital decompression following strabismus surgery in patients with Type II ophthalmic Graves' disease.

PubMed

Ellis, Michael P; Broxterman, Emily C; Hromas, Alan R; Whittaker, Thomas J; Sokol, Jason A

2018-01-10

Surgical management of ophthalmic Graves' disease traditionally involves, in order, orbital decompression, followed by strabismus surgery and eyelid surgery. Nunery et al. previously described two distinct sub-types of patients with ophthalmic Graves' disease; Type I patients exhibit no restrictive myopathy (no diplopia) as opposed to Type II patients who do exhibit restrictive myopathy (diplopia) and are far more likely to develop new-onset worsening diplopia following medial wall and floor decompression. Strabismus surgery involving extra-ocular muscle recession has, in turn, been shown to potentially worsen proptosis. Our experience with Type II patients who have already undergone medial wall and floor decompression and strabismus surgery found, when additional decompression is necessary, deep lateral wall decompression (DLWD) appears to have a low rate of post-operative primary-gaze diplopia. A case series of four Type II ophthalmic Graves' disease patients, all of whom had already undergone decompression and strabismus surgery, and went on to develop worsening proptosis or optic nerve compression necessitating further decompression thereafter. In all cases, patients were treated with DLWD. Institutional Review Board approval was granted by the University of Kansas. None of the four patients treated with this approach developed recurrent primary-gaze diplopia or required strabismus surgery following DLWD. While we still prefer to perform medial wall and floor decompression as the initial treatment for ophthalmic Graves' disease, for proptosis following consecutive strabismus surgery, DLWD appears to be effective with a low rate of recurrent primary-gaze diplopia.

A Profile of Neuro-Ophthalmic Practice Around the World.

PubMed

Frohman, Larry P

2018-03-01

To compare contrast neuro-ophthalmic practice in various countries, an 18-question survey was sent to the international North American Neuro-Ophthalmology Society (NANOS) members in the spring of 2016. At least 1 NANOS member was contacted for each non-US nation in the NANOS membership roster. If there were multiple NANOS members from 1 country, multiple were contacted. If responses were received from more than 1 person from a single country, the first response received was used as the source data. The survey (in English) was emailed to 47 NANOS members from 31 countries. Twenty responses were received representing members from 15 nations. In all 15 nations, at least half of the neuro-ophthalmologists were trained as ophthalmologists. In 60% of nations, at least half of the neuro-ophthalmologists were trained internally, whereas in 33% of countries, at least half were trained in the United States. The number of physicians who practiced a significant amount of neuro-ophthalmology ranged from low (0.08/million, India) to high (3.10/million, Israel). Countries having the highest percentage of neuro-ophthalmologists exclusively practicing neuro-ophthalmology also were those with better patient access to neuro-ophthalmic care. Requirement of approval to see a neuro-ophthalmologist or for imaging studies requested by neuro-ophthalmologists was not typical. In most nations, academic neuro-ophthalmologists were paid a straight salary. In no nation were neuro-ophthalmologists paid more than another ophthalmic subspecialty. Individual national health care system designs and compensation models have had a profound influence on the rewards and challenges that face neuro-ophthalmologists. There seems to have been a connection between recognition of the discipline, financial rewards of neuro-ophthalmic practice, conditions that permit full-time neuro-ophthalmic practice, and patient access to care. A higher percentage of gross national product for health care did not seem to insure an adequate supply of neuro-ophthalmologists.

Ocular and systemic pharmacokinetics of lidocaine hydrochloride ophthalmic gel in rabbits after topical ocular administration.

PubMed

Liu, Bing; Ding, Li; Xu, Xiaowen; Lin, Hongda; Sun, Chenglong; You, Linjun

2015-12-01

Lidocaine hydrochloride ophthalmic gel is a novel ophthalmic preparation for topical ocular anesthesia. The study is aimed at evaluating the ocular and systemic pharmacokinetics of lidocaine hydrochloride 3.5 % ophthalmic gel in rabbits after ocular topical administration. Thirty-six rabbits were randomly placed in 12 groups (3 rabbits per group). The rabbits were quickly killed according to their groups at 0 (predose), 0.0833, 0.167, 0.333, 0.667, 1, 1.5, 2, 3, 4, 6, and 8 h postdose and then the ocular tissue and plasma samples were collected. All the samples were analyzed by a validated LC-MS/MS method. The test result showed that the maximum concentration (C max) of lidocaine in different ocular tissues and plasma were all achieved within 20 min after drug administration, and the data of C max were (2,987 ± 1814) μg/g, (44.67 ± 12.91) μg/g, (26.26 ± 7.19) μg/g, (11,046 ± 2,734) ng/mL, and (160.3 ± 61.0) ng/mL for tear fluid, cornea, conjunctiva, aqueous humor, and plasma, respectively. The data of the elimination half-life in these tissues were 1.5, 3.2, 3.5, 1.9, and 1.7 h for tear fluid, cornea, conjunctiva, aqueous humor, and plasma, respectively. The intraocular lidocaine levels were significantly higher than that in plasma, and the elimination half-life of lidocaine in cornea, conjunctiva, and aqueous humor was relatively longer than that in tear fluid and plasma. The high intraocular penetration, low systemic exposure, and long duration in the ocular tissues suggested lidocaine hydrochloride 3.5 % ophthalmic gel as an effective local anesthetic for ocular anesthesia during ophthalmic procedures.

Periocular dermatitis: a report of 401 patients.

PubMed

Temesvári, E; Pónyai, G; Németh, I; Hidvégi, B; Sas, A; Kárpáti, S

2009-02-01

Periocular contact dermatitis may appear as contact conjunctivitis, contact allergic and/or irritative eyelid and periorbital dermatitis, or a combination of these symptoms. The clinical symptoms may be induced by several environmental and therapeutic contact allergens. The aim of the present study was to map the eliciting contact allergens in 401 patients with periocular dermatitis (PD) by patch testing with environmental and ophthalmic contact allergens. Following the methodics of international requirements, 401 patients were tested with contact allergens of the standard environmental series, 133 of 401 patients with the Brial ophthalmic basic and supplementary series as well. Contact hypersensitivity was detected in 34.4% of the patients. Highest prevalence was seen in cases of PD without other symptoms (51.18%), in patients of PD associated with ophthalmic complaints (OC; 30.4%), and PD associated with atopic dermatitis (AD; 27.9%). In the subgroup of PD associated with seborrhoea (S) and rosacea (R), contact hypersensitivity was confirmed in 17.6%. Most frequent sensitisers were nickel sulphate (in 8.9% of the tested 401 patients), fragrance mix I (4.5%), balsam of Peru (4.0%), paraphenylendiamine (PPD) (3.7%), and thiomersal (3.5%). By testing ophthalmic allergens, contact hypersensitivity was observed in nine patients (6.7% of the tested 133 patients). The most common confirmed ophthalmic allergens were cocamidopropyl betaine, idoxuridine, phenylephrine hydrochloride, Na chromoglycinate, and papaine. Patients with symptoms of PD were tested from 1996 to 2006. The occurence of contact hypersensitivity in PD patients was in present study 34.4%. A relatively high occurrence was seen in cases of PD without other symptoms, in PD + OC and in PD + AD patients. The predominance of environmental contact allergens was remarkable: most frequent sensitizers were nickel sulphate, fragrance mix I, balsam of Peru, thiomersal, and PPD. The prevalence of contact hypersensitivity to ophthalmic allergens did not exceed l.5%.

N-Acetylcarnosine and histidyl-hydrazide are potent agents for multitargeted ophthalmic therapy of senile cataracts and diabetic ocular complications.

PubMed

Babizhayev, Mark A; Guiotto, Andrea; Kasus-Jacobi, Anne

2009-01-01

In human diabetes, the deleterious effects of chronic hyperglycemia are the result of excessive nonenzymatic modification of proteins and phospholipids by glucose and its by-products leading to the formation of irreversible oxidized, aromatic, and fluorescent ligands known as advanced glycation end products. This glycation process has been associated with deleterious health effects. The present invention provides the potent inhibitors of protein glycation and AGEs formation, which are particularly advantageous for eyedrop delivery in the prevention and treatment of diabetes- and age-related pathologies. We proposed a deglycation system involving removal, by transglycation of sugar or aldehyde moieties from the Schiff bases by ophthalmic aldehyde scavenger L-carnosine derived from its ocular bioactivating sustained release prodrug 1% N-acetylcarnosine (NAC) lubricant eyedrops containing a mucoadhesive cellulose compound combined with corneal absorption promoters in drug delivery system. Carnosine analogs bearing the histidyl-hydrazide moiety were synthesized and patented in ophthalmic formulations with NAC bioactivating prodrug to moderate the enzymatic hydrolysis of a dipeptide by carnosinase (inhibited by a nonhydrolyzable substrate analog so that this keeps steadier levels of the drug active principle in the aqueous humor). Leucyl-histidylhydrazide peptidomimetic demonstrated the transglycation activity more pronounced than L-carnosine accounting for the ability of either molecule to reverse pre-existing, glycation-induced, cross-linking, and checking the nonenzymatic glycation cascade in the ophthalmic pathologies. The ophthalmic drug N-acetylcarnosine eye drop formulation with sustained time- release and increased absorption of L-carnosine in the aqueous humor (a prolonged effective dose) showed follow-up treatment efficacy for age-related cataracts for enrolled patients into the randomized double blind placebo controlled crossover clinical trial, and in over 50250 various cohort patients, was demonstrated to have an efficacy, safety and good tolerability for prevention and treatment of visual impairment in the older population data base. The bioactivating antioxidant NAC and histidyl-hydrazide are potent agents with the pleiotropic effects for ophthalmic therapy of senile cataracts and diabetic ocular complications.

Location of the internal carotid artery and ophthalmic artery segments for non-invasive intracranial pressure measurement by multi-depth TCD.

PubMed

Hamarat, Yasin; Deimantavicius, Mantas; Kalvaitis, Evaldas; Siaudvytyte, Lina; Januleviciene, Ingrida; Zakelis, Rolandas; Bartusis, Laimonas

2017-12-01

The aim of the present study was to locate the ophthalmic artery by using the edge of the internal carotid artery (ICA) as the reference depth to perform a reliable non-invasive intracranial pressure measurement via a multi-depth transcranial Doppler device and to then determine the positions and angles of an ultrasonic transducer (UT) on the closed eyelid in the case of located segments. High tension glaucoma (HTG) patients and healthy volunteers (HVs) undergoing non-invasive intracranial pressure measurement were selected for this prospective study. The depth of the edge of the ICA was identified, followed by a selection of the depths of the IOA and EOA segments. The positions and angles of the UT on the closed eyelid were measured. The mean depth of the identified ICA edge for HTG patients was 64.3 mm and was 63.0 mm for HVs (p = 0.21). The mean depth of the selected IOA segment for HTG patients was 59.2 mm and 59.3 mm for HVs (p = 0.91). The mean depth of the selected EOA segment for HTG patients was 48.5 mm and 49.8 mm for HVs (p = 0.14). The difference in the located depths of the segments between groups was not statistically significant. The results showed a significant difference in the measured UT angles in the case of the identified edge of the ICA and selected ophthalmic artery segments (p = 0.0002). We demonstrated that locating the IOA and EOA segments can be achieved using the edge of the ICA as a reference point. OA: ophthalmic artery; IOA: intracranial segments of the ophthalmic artery; EOA: extracranial segments of the ophthalmic artery; ICA: internal carotid artery; UT: ultrasonic transducer; HTG: high tension glaucoma; SD: standard deviation; ICP: intracranial pressure; TCD: transcranial Doppler.

Outcomes of an inner-city vision outreach program: give kids sight day.

PubMed

Dotan, Gad; Truong, Billy; Snitzer, Melanie; McCauley, Colleen; Martinez-Helfman, Sarah; Santa Maria, Kathy; Levin, Alex V

2015-05-01

Low-socioeconomic urban children often do not have access to ophthalmic care. To characterize the demographic characteristics and ophthalmic conditions in children attending Give Kids Sight Day (GKSD), an outreach ophthalmic care program held annually in Philadelphia, Pennsylvania, providing vision screening and immediate treatment when needed. Retrospective case-series study of children attending GKSD in 2012 (GKSD 2012) at an ophthalmology center in Philadelphia. Registration forms and records of all children attending GKSD 2012 were reviewed. Demographic characteristics, insurance status, spoken languages, reasons for attending, prior failure of vision screening, and attendance pattern of previous events were analyzed. The ophthalmological findings of these children were examined, including refractive errors, need for optical correction, and diagnoses for which continuous ophthalmic care was necessary. For children who needed ophthalmic follow-up, the rate of return to clinic and barriers for continuous care were analyzed. We studied 924 children (mean age, 9 years; age range, 0-18 years; 51% female; 25% speaking a non-English language) coming from 584 families who attended GKSD 2012, of whom 27% were uninsured and 10% were not aware of their insurance status. Forty-two percent of participants had public insurance, which covered vision care and glasses, but 35% did not know their benefits and did not realize vision care was covered. Forty-nine percent of children attended because they failed community vision screening. Provision of free glasses and failure of previous vision screening were the most common reasons families elected to attend GKSD (64% and 49%, respectively). Eighty-five percent of children attended GKSD 2012 for the first time, whereas 15% attended prior events. Glasses were provided to 61% of attendees. Ten percent of the attendees needed continuous ophthalmic care, most commonly for amblyopia. Ten children needed ocular surgery for cataract, strabismus, nystagmus, ptosis, or nasolacrimal duct obstruction. With the assistance of a social worker, 59% of children requiring continuous treatment returned to the clinic, compared with 2% in prior years before social worker intervention. Programs such as GKSD can bridge the gap between successful vision screening and ophthalmic treatment, a gap that often occurs in low-socioeconomic urban populations. Those with public insurance coverage for vision services may not realize these services are covered. Social worker intervention is useful in overcoming common barriers to follow-up care.

Besifloxacin ophthalmic suspension 0.6% in patients with bacterial conjunctivitis: A multicenter, prospective, randomized, double-masked, vehicle-controlled, 5-day efficacy and safety study.

PubMed

Karpecki, Paul; Depaolis, Michael; Hunter, Judy A; White, Eric M; Rigel, Lee; Brunner, Lynne S; Usner, Dale W; Paterno, Michael R; Comstock, Timothy L

2009-03-01

Besifloxacin ophthalmic suspension 0.6% is a new topical fluoroquinolone for the treatment of bacterial conjunctivitis. Besifloxacin has potent in vitro activity against a broad spectrum of ocular pathogens, including drug-resistant strains. The primary objective of this study was to compare the clinical and microbiologic efficacy of besifloxacin ophthalmic suspension 0.6% with that of vehicle (the formulation without besifloxacin) in the treatment of bacterial conjunctivitis. This was a multicenter, prospective, randomized, double-masked, vehicle-controlled, parallel-group study in patients with acute bacterial conjunctivitis. Patients received either topical besifloxacin ophthalmic suspension or vehicle administered 3 times daily for 5 days. At study entry and on days 4 and 8 (visits 2 and 3), a clinical assessment of ocular signs and symptoms was performed in both eyes, as well as pinhole visual acuity testing, biomicroscopy, and culture of the infected eye(s). An ophthalmoscopic examination was performed at study entry and on day 8. The primary efficacy outcome measures were clinical resolution and eradication of the baseline bacterial infection on day 8 in culture-confirmed patients. The safety evaluation included adverse events, changes in visual acuity, and biomicroscopy and ophthalmoscopy findings in all patients who received at least 1 dose of active treatment or vehicle. The safety population consisted of 269 patients (mean [SD] age, 34.2 [22.3] years; 60.2% female; 82.5% white) with acute bacterial conjunctivitis. The culture-confirmed intent-to-treat population consisted of 118 patients (60 besifloxacin ophthalmic suspension, 58 vehicle). Significantly more patients receiving besifloxacin ophthalmic suspension than vehicle had clinical resolution of the baseline infection at visit 3 (44/60 [73.3%] vs 25/58 [43.1%], respectively; P < 0.001). Rates of bacterial eradication also were significantly greater with besifloxacin ophthalmic suspension compared with vehicle at visit 3 (53/60 [88.3%] vs35/58 [60.3%]; P < 0.001). The cumulative frequency of adverse events did not differ significantly between the 2 groups (69/137 [50.4%] and 70/132 [53.0%]). The most common ocular adverse events were eye pain (20/190 treated eyes [10.5%] and 13/188 [6.9%]), blurred vision (20/190 [10.5%] and 22/188 [11.7%]), and eye irritation (14/190 [7.4%] and 23/188 [12.2%]); these events were of mild or moderate severity. Changes in visual acuity and treatment-emergent events observed on biomicroscopy and direct ophthalmoscopy also were comparable between treatment groups. Besifloxacin ophthalmic suspension 0.6% given 3 times daily for 5 days was both efficacious and well tolerated compared with vehicle in the treatment of these patients with bacterial conjunctivitis. ClinicalTrials.gov Identifier: NCT00622908.

Ability of Bottle Cap Color to Facilitate Accurate Patient-Physician Communication Regarding Medication Identity in Patients with Glaucoma.

PubMed

Dave, Pujan; Villarreal, Guadalupe; Friedman, David S; Kahook, Malik Y; Ramulu, Pradeep Y

2015-12-01

To determine the accuracy of patient-physician communication regarding topical ophthalmic medication use based on bottle cap color, particularly among individuals who may have acquired color vision deficiency from glaucoma. Cross-sectional, clinical study. Patients aged ≥18 years with primary open-angle, primary angle-closure, pseudoexfoliation, or pigment dispersion glaucoma, bilateral visual acuity of ≥20/400, and no concurrent conditions that may affect color vision. A total of 100 patients provided color descriptions of 11 distinct medication bottle caps. Color descriptors were then presented to 3 physicians. Physicians matched each color descriptor to the medication they thought the descriptor was describing. Frequency of patient-physician agreement, occurring when all 3 physicians accurately matched the color descriptor to the correct medication. Multivariate regression models evaluated whether patient-physician agreement decreased with degree of better-eye visual field (VF) damage, color descriptor heterogeneity, or color vision deficiency, as determined by the Hardy-Rand-Rittler (HRR) score and Lanthony D15 color confusion index (D15 CCI). Subjects had a mean age of 69 (±11) years, with VF mean deviation of -4.7 (±6.0) and -10.9 (±8.4) decibels (dB) in the better- and worse-seeing eyes, respectively. Patients produced 102 unique color descriptors to describe the colors of the 11 bottle caps. Among individual patients, the mean number of medications demonstrating agreement was 6.1/11 (55.5%). Agreement was less than 15% for 4 medications (prednisolone acetate [generic], betaxolol HCl [Betoptic; Alcon Laboratories Inc., Fort Worth, TX], brinzolamide/brimonidine [Simbrinza; Alcon Laboratories Inc.], and latanoprost [Xalatan; Pfizer, Inc., New York, NY]). Lower HRR scores and higher D15 CCI (both indicating worse color vision) were associated with greater VF damage (P < 0.001). Extent of color vision deficiency and color descriptor heterogeneity significantly predicted agreement in multivariate models (odds of agreement = 0.90 per 1 point decrement in HRR score, P < 0.001; odds of agreement = 0.30 for medications exhibiting high heterogeneity [≥11 descriptors], P = 0.007). Physician understanding of patient medication use based solely on bottle cap color is frequently incorrect, particularly in patients with glaucoma who may have color vision deficiency. Errors based on communication using bottle cap color alone may be common and could lead to confusion and harm. Copyright © 2015 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

The preservative polyquaternium-1 increases cytoxicity and NF-kappaB linked inflammation in human corneal epithelial cells

PubMed Central

Paimela, Tuomas; Ryhänen, Tuomas; Kauppinen, Anu; Marttila, Liisa; Salminen, Antero

2012-01-01

Purpose In numerous clinical and experimental studies, preservatives present in eye drops have had detrimental effects on ocular epithelial cells. The aim of this study was to compare the cytotoxic and inflammatory effects of the preservative polyquaternium-1 (PQ-1) containing Travatan (travoprost 0.004%) and Systane Ultra eye drops with benzalkonium chloride (BAK) alone or BAK-preserved Xalatan (0.005% latanoprost) eye drops in HCE-2 human corneal epithelial cell culture. Methods HCE-2 cells were exposed to the commercial eye drops Travatan, Systane Ultra, Xalatan, and the preservative BAK. Cell viability was determined using colorimetric MTT (3-(4,5-dimethyldiazol-2-yl)-2,5-diphenyltetrazolium bromide) assay and by release of lactate dehydrogenase (LDH). Induction of apoptosis was measured with a using a colorimetric caspase-3 assay kit. DNA binding of the nuclear factor kappa B (NF-κB) transcription factor, and productions of the proinflammatory cytokines, interleukins IL-6 and IL-8, were determined using an enzyme-linked immunosorbent assay (ELISA) method. Results Cell viability, as measured by the MTT assay, declined by up to 50% after exposure to Travatan or Systane Ultra solutions which contain 0.001% PQ-1. BAK at 0.02% rather than at 0.001% concentration evoked total cell death signs on HCE-2 cells. In addition, cell membrane permeability, as measured by LDH release, was elevated by sixfold with Travatan and by a maximum threefold with Systane Ultra. Interestingly, Travatan and Systane Ultra activated NF-κB and elevated the secretion of inflammation markers IL-6 by 3 to eightfold and IL-8 by 1.5 to 3.5 fold, respectively, as analyzed with ELISA. Conclusions Eye drops containing PQ-1 evoke cytotoxicity and enhance the NF-κB driven inflammation reaction in cultured HCE-2 cells. Our results indicate that these harmful effects of ocular solutions preserved with PQ-1 should be further evaluated in vitro and in vivo. PMID:22605930

21 CFR 524.154 - Bacitracin or bacitracin zinc-neomycin sulfate-polymyxin B sulfate ophthalmic ointment.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Bacitracin or bacitracin zinc-neomycin sulfate-polymyxin B sulfate ophthalmic ointment. 524.154 Section 524.154 Food and Drugs FOOD AND DRUG ADMINISTRATION... TOPICAL DOSAGE FORM NEW ANIMAL DRUGS § 524.154 Bacitracin or bacitracin zinc-neomycin sulfate-polymyxin B...

21 CFR 524.154 - Bacitracin or bacitracin zinc-neomycin sulfate-polymyxin B sulfate ophthalmic ointment.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Bacitracin or bacitracin zinc-neomycin sulfate-polymyxin B sulfate ophthalmic ointment. 524.154 Section 524.154 Food and Drugs FOOD AND DRUG ADMINISTRATION... TOPICAL DOSAGE FORM NEW ANIMAL DRUGS § 524.154 Bacitracin or bacitracin zinc-neomycin sulfate-polymyxin B...

78 FR 13350 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-27

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug... of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee...

Mississippi Curriculum Framework for Ophthalmic Technology (Program CIP: 51.1801--Opticianry/Dispensing Optician). Postsecondary Programs.

ERIC Educational Resources Information Center

Mississippi Research and Curriculum Unit for Vocational and Technical Education, State College.

This document, which is intended for use by community and junior colleges throughout Mississippi, contains curriculum frameworks for the course sequences in the ophthalmic technology program. Presented in the introductory section are a description of the program and suggested course sequence. Section I lists baseline competencies, and section II…

Ophthalmic Surgery in Prion Diseases

PubMed Central

Hamaguchi, Tsuyoshi; Noguchi-Shinohara, Moeko; Nakamura, Yosikazu; Sato, Takeshi; Kitamoto, Tetsuyuki; Mizusawa, Hidehiro

2007-01-01

Eleven (1.8%) of 597 patients underwent ophthalmic surgery within 1 month before the onset of prion disease or after the onset. All ophthalmologists reused surgical instruments that had been incompletely sterilized to eliminate infectious prion protein. Ophthalmologists should be aware of prion diseases as a possible cause of visual symptoms and use disposable instruments whenever possible. PMID:17370537

A New Anatomic Variation: Coexistence of Both Dandy-Walker Variant and Ophthalmic Artery Originating From Contralateral Internal Carotid Artery.

PubMed

Ogul, Hayri; Havan, Nuri; Gedikli, Yusuf; Pirimoglu, Berhan; Kantarci, Mecit

2016-06-01

The authors report on 1 patient of variant origin of right ophthalmic artery (OA) from ophthalmic segment of the left internal carotid artery. A 41-year-old man was performed magnetic resonance (MR) imaging and MR angiography. Cerebral MR imaging revealed a Dandy-Walker variant. In MR angiography the authors observed this unusual variant of origin of OA and a complete occlusion of right internal carotid artery. To the authors' knowledge, this is the first patient who has coincidence of both Dandy-Walker variant and origin of OA from contralateral internal carotid artery. Careful observation of MR angiography images with maximum intensity projection is very important for detecting rare vascular variations.

CRISPR-mediated Ophthalmic Genome Surgery.

PubMed

Cho, Galaxy Y; Abdulla, Yazeed; Sengillo, Jesse D; Justus, Sally; Schaefer, Kellie A; Bassuk, Alexander G; Tsang, Stephen H; Mahajan, Vinit B

2017-09-01

Clustered regularly interspaced short palindromic repeats (CRISPR) is a genome engineering system with great potential for clinical applications due to its versatility and programmability. This review highlights the development and use of CRISPR-mediated ophthalmic genome surgery in recent years. Diverse CRISPR techniques are in development to target a wide array of ophthalmic conditions, including inherited and acquired conditions. Preclinical disease modeling and recent successes in gene editing suggest potential efficacy of CRISPR as a therapeutic for inherited conditions. In particular, the treatment of Leber congenital amaurosis with CRISPR-mediated genome surgery is expected to reach clinical trials in the near future. Treatment options for inherited retinal dystrophies are currently limited. CRISPR-mediated genome surgery methods may be able to address this unmet need in the future.

Prospective Observational Post-marketing Study of Tafluprost 0.0015%/Timolol 0.5% Combination Ophthalmic Solution for Glaucoma and Ocular Hypertension: Short-Term Efficacy and Safety.

PubMed

Takagi, Yasutaka; Osaki, Hirotaka; Yamashita, Tomohiro; Kai, Yasuhiko

2016-12-01

The intraocular pressure (IOP)-lowering effect and safety of tafluprost 0.0015%/timolol maleate 0.5% combination ophthalmic solution (Taf-TFC) were investigated in a real-world clinical setting. A prospective up to 2-year (more than 1 year) observational study has been initiated to collect data on the IOP, conjunctival hyperemia score, corneal staining score, and adverse events suffered by patients with glaucoma or ocular hypertension treated at 3 months, and up to 2 years (more than 1 year) after initiating treatment with Taf-TFC. The 3-month findings are reported here. Among 439 patients enrolled at 100 institutions in Japan, most had normal tension glaucoma (45.3%) or primary open angle glaucoma (36.0%). Adverse drug reaction (ADR) occurred in 5.01%. The important ADRs were conjunctival hyperemia (five patients), blepharitis (four patients), and punctate keratitis (two patients). Serious adverse reactions occurred in two patients (three events). In 410 patients with data both before and after treatment, baseline mean IOP was 17.5 ± 5.0 mmHg, and it was significantly decreased after 1, 2, and 3 months (all P < 0.05, paired-t test). IOP was significantly reduced in patients switched to Taf-TFC from either prostaglandin or β-blocker monotherapy. IOP also decreased significantly in patients switched from a prostaglandin/timolol fixed combination, but not in patients switched from concomitant use of a prostaglandin analog and a β-blocker. The use of Taf-TFC did not worsen the adherence in most patients. Taf-TFC significantly reduced the IOP in patients with glaucoma or ocular hypertension treated in daily clinical practice with controllable or recoverable ADRs in short period. Taf-TFC was effective regardless of treatment patterns, and particularly, Taf-TFC significantly reduced IOP in cases in which requiring the second line therapy as insufficient of monotherapy. Santen Pharmaceutical Co., Ltd., Osaka, Japan.

Bromfenac 0.09% bioavailability in aqueous humor, prophylactic effect on cystoid macular edema, and clinical signs of ocular inflammation after phacoemulsification in a Mexican population

PubMed Central

Palacio, Claudia; Fernández De Ortega, Lourdes; Bustos, Francisco R; Chávez, Eduardo; Oregon-Miranda, Aldo A; Mercado-Sesma, Arieh R

2016-01-01

Purpose The purpose of this study was to evaluate the aqueous humor bioavailability and clinical efficacy of bromfenac 0.09% vs nepafenac on the presence of cystoid macular edema (CME) after phacoemulsification. Material and methods A Phase II, double-blind, masked, active-controlled, multicenter, clinical trial of 139 subjects, randomized to either a bromfenac 0.09% ophthalmic solution (n=69) or nepafenac 0.1% (n=70). Subjects instilled a drop three times a day for a period of 30 days. Follow-up visits were on days 2, 7, 15, 30, and 60. Biomicroscopy, clinical ocular signs, and assessment of posterior segment were performed. The primary efficacy endpoints included the presence of CME evaluated by optical coherence tomography. Safety evaluation included intraocular pressure, transaminase enzymes, lissamine green, and fluorescein stain. Results The demographic and efficacy variables were similar between groups at baseline. The presence of pain, photophobia, conjunctival hyperemia, chemosis, cellularity, and corneal edema disappeared by day 30 in both groups. The central retinal thickness did not show significant changes after treatment when compared to baseline as follows: in the bromfenac group (247.2±32.9 vs 252.0±24.9 μm; P=0.958) and in nepafenac group (250.8±34 vs 264.0±34.1 μm; P=0.137), respectively. A statistically significant difference was observed between bromfenac and nepafenac group: (252.0±24.9 vs 264.0±34.1 μm; P=0.022), at day 30, respectively; even though there was no clinical relevance in the presentation of CME. There were no significant alterations in intraocular pressure, either lissamine green or fluorescein stains. The adverse events were not related to the interventions. Conclusion Bromfenac 0.09% ophthalmic solution showed similar clinical efficacy to reduce the presentation of CME after phacoemulsification compared to nepafenac 0.01%. PMID:26869758

Bromfenac 0.09% bioavailability in aqueous humor, prophylactic effect on cystoid macular edema, and clinical signs of ocular inflammation after phacoemulsification in a Mexican population.

PubMed

Palacio, Claudia; Fernández De Ortega, Lourdes; Bustos, Francisco R; Chávez, Eduardo; Oregon-Miranda, Aldo A; Mercado-Sesma, Arieh R

2016-01-01

The purpose of this study was to evaluate the aqueous humor bioavailability and clinical efficacy of bromfenac 0.09% vs nepafenac on the presence of cystoid macular edema (CME) after phacoemulsification. A Phase II, double-blind, masked, active-controlled, multicenter, clinical trial of 139 subjects, randomized to either a bromfenac 0.09% ophthalmic solution (n=69) or nepafenac 0.1% (n=70). Subjects instilled a drop three times a day for a period of 30 days. Follow-up visits were on days 2, 7, 15, 30, and 60. Biomicroscopy, clinical ocular signs, and assessment of posterior segment were performed. The primary efficacy endpoints included the presence of CME evaluated by optical coherence tomography. Safety evaluation included intraocular pressure, transaminase enzymes, lissamine green, and fluorescein stain. The demographic and efficacy variables were similar between groups at baseline. The presence of pain, photophobia, conjunctival hyperemia, chemosis, cellularity, and corneal edema disappeared by day 30 in both groups. The central retinal thickness did not show significant changes after treatment when compared to baseline as follows: in the bromfenac group (247.2±32.9 vs 252.0±24.9 μm; P=0.958) and in nepafenac group (250.8±34 vs 264.0±34.1 μm; P=0.137), respectively. A statistically significant difference was observed between bromfenac and nepafenac group: (252.0±24.9 vs 264.0±34.1 μm; P=0.022), at day 30, respectively; even though there was no clinical relevance in the presentation of CME. There were no significant alterations in intraocular pressure, either lissamine green or fluorescein stains. The adverse events were not related to the interventions. Bromfenac 0.09% ophthalmic solution showed similar clinical efficacy to reduce the presentation of CME after phacoemulsification compared to nepafenac 0.01%.

The effects of 3% diquafosol sodium application on the tear functions and ocular surface of the Cu,Zn-superoxide dismutase-1 (Sod1)-knockout mice.

PubMed

Kojima, Takashi; Dogru, Murat; Ibrahim, Osama M; Nagata, Taeko; Higa, Kazunari; Shimizu, Takahiko; Shirasawa, Takuji; Satake, Yoshiyuki; Shimazaki, Seika; Shimazaki, Jun; Tsubota, Kazuo

2014-01-01

To investigate the role of a water and mucin secretagogue (3% diquafosol sodium eye drops) on the tear function and conjunctival ocular surface changes in Sod1(-/-) in comparison to the wild-type (WT) mice. Fourteen eyes of 7 Sod1(-/-) male mice with C57BL/background and 14 eyes of 7 C57BL6 strain wild-type male mice were examined at 40 weeks in this study. All mice had application of 3% diquafosol ophthalmic solution six times a day for 2 weeks. Tear film stability and corneal epithelial damage was evaluated by fluorescein and Rose Bengal stainings. Anterior segment photography was performed before and after eye drop instillations. Aqueous tear quantity was measured with phenol red-impregnated cotton threads without anesthesia. Animals were sacrificed at 42 weeks after diquafosol treatment and the whole globe specimens were subjected to periodic acid Schiff staining. Goblet cell density was quantified by J Image software. Quantitative real-time PCR for conjunctival muc 5AC messenger RNA expression was also performed. Sod1(-/-) mice had significantly higher fluorescein staining scores compared to the WT mice before eye drop instillation. The mean tear film breakup time, Rose Bengal staining scores, and muc5 messenger RNA expression improved significantly with diquafosol treatment in both the WT and the knockout mice. The mean fluorescein staining score and aqueous tear quantity significantly improved in the Sod1(-/-) mice with treatment. A notable and consistent increase in goblet cells and decrease in inflammatory cell infiltrates could be confirmed in all specimens after 2 weeks of diquafosol eye drop application. Three percent diquafosol ophthalmic solution appears to be effective in the treatment of ocular surface disease in this age-related dry eye disease mouse model.

Potentiation of intraocular absorption and drug metabolism of N-acetylcarnosine lubricant eye drops: drug interaction with sight threatening lipid peroxides in the treatment for age-related eye diseases.

PubMed

Babizhayev, Mark A

2009-01-01

Cataract is the dominant cause of blindness worldwide. Studies of the morphological structure and biophysical changes of the lens in human senile cataracts have demonstrated the disappearance of normal fiber structure in the opaque region of the lens and the disintegration of the lens fiber plasma membrane in the lens tissue. Morphological and biochemical techniques have revealed the regions in human cataractous lenses in which the plasma membrane derangement occurs as the primary light scattering centers which cause the observed lens opacity. Human cataract formation is mostly considered to be a multifactorial disease; however, oxidative stress might be one of the leading causes for both nuclear and cortical cataract. Phospholipid molecules modified with oxygen, accumulating in the lipid bilayer, change its geometry and impair lipid-lipid and protein-lipid interactions in lenticular fiber membranes. Electron microscopy data of human lenses at various stages of age-related cataract document that these disruptions were globules, vacuoles, multilamellar membranes, and clusters of highly undulating membranes. The opaque shades of cortical cataracts represent cohorts of locally affected fibres segregated from unaffected neighbouring fibres by plasma membranes. Other potential scattering centers found throughout the mature cataract nucleus included variations in staining density between adjacent cells, enlarged extracellular spaces between undulating membrane pairs, and protein-like deposits in the extracellular space. These affected parts had membranes with a fine globular aspect and in cross-section proved to be filled with medium to large globular elements. Lipid peroxidation (LPO) is a pathogenetic and causative factor of cataract. Increased concentrations of primary molecular LPO products (diene conjugates, lipid hydroperoxides, fatty acid oxy-derivatives) and end fluorescent LPO products were detected in the lipid moieties of the aqueous humor samples and human lenses obtained from patients with senile and complicated cataracts as compared to normal donors. Utilizing the pharmacokinetic studies and the specific purity N-acetylcarnosine (NAC) ingredient as a source of pharmacological principal L-carnosine, we have created an ophthalmic time-release prodrug form combined with a muco-adhesive lubricant compound carboxymethylcellulose and other essential corneal absorption promoter excipients tailoring the increased intraocular absorption of L-carnosine in the aqueous humor and optimizing its specific effect in producing the basic antioxidant activity in vivo and reducing toxic effects of lipid peroxides to the crystalline lens. L-Carnosine that finds its way into the aqueous humor can accumulate in the lens tissue for a reasonable period of time. However, administration of pure L-carnosine (1% solution) to the rabbit eye (instillation, subconjunctival injection) does not lead to accumulation of this natural compound in the aqueous humor over 30 min in concentration exceeding that in the placebo-treated matched eyes, and its effective concentration is exhausted more rapidly. The NAC prodrug eye drops optimize the clinical effects for the treatment of ophthalmic disorders (such as prevention and reversal of cataracts in human and animal [canine] eyes). The data provided predict a particular NAC ophthalmic prodrug's clinical effect; the suitable magnitude and duration of this effect suggest dose-related bioavailability of L-camosine released from NAC in the aqueous humor of the anterior eye segment. The ophthalmic NAC drug shows promise in the treatment of a range of ophthalmic disorders which have a component of oxidative stress in their genesis (including cataract and after-cataract, glaucoma, dry eye, vitreous floaters, inflammatory disorders, corneal, retinal and systemic diseases [such as diabetes mellitus and its ophthalmic complications]). The clinical efficacy of N-acetylcarnosine lubricant eye drops in ripe cataracts and retinal disorders can be enhanced in combined treatment with a patented oral formulation (Can-C Plus) of non-hydrolyzed carnosine including synergistic compounds (histidine, D-panthethine) with chaperone activity towards lens crystallins and oral supplementation with N-acetylcysteine providing an alternate means of boosting reduced glutathione (GSH) synthesis in the lens.