Science.gov

Sample records for ophthalmic solutions

  1. Stability of tacrolimus ophthalmic solution.

    PubMed

    Ezquer-Garin, Carlos; Ferriols-Lisart, Rafael; Alós-Almiñana, Manuel

    2017-07-01

    The stability of 0.3-mg/mL tacrolimus ophthalmic solution at different storage temperatures was studied. A sterile ophthalmic solution of 0.3 mg/mL tacrolimus was prepared in triplicate under aseptic conditions by diluting tacrolimus in eye drops. Three aliquots of this solution were transferred into polypropylene bottles and stored at 25, 2-8, or -15 to -25 °C. Samples were collected immediately after preparation and at selected time points and assayed in triplicate using high-performance liquid chromatography (HPLC). Samples were also visually examined for macroscopic changes. The 0.3-mg/mL tacrolimus solution was also exposed to acidic treatment and heat to force its degradation and to evaluate the selectivity of the analytic method. The tacrolimus ophthalmic solution was considered stable if at least 90% of the mean initial concentration remained when analyzed by HPLC. When stored at 2-8 °C and between -15 and -25 °C, at least 90% of the initial tacrolimus concentration remained throughout the 85-day study period. There were no significant differences in tacrolimus concentrations between the starting and ending points (p > 0.05). However, when tacrolimus solution was stored at 25 °C, the percentage of the initial tacrolimus concentration remaining had decreased to less than 90% on day 28. Tacrolimus diluted to 0.3 mg/mL in eye drop solution was stable for 20 days when stored at 25 °C and for at least 85 days when stored at 2-8 °C or between -15 and -25 °C in polypropylene bottles and protected from light. Copyright © 2017 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

  2. Extemporaneous preparation of antibiotic ophthalmic solutions.

    PubMed

    Hammond, R W; Walker, T P; McClung, H F; Edmondson, W

    1996-03-01

    Until the introduction of ocular ciprofloxacin, the standard of practice in treating bacterial corneal ulcers required topical antibiotic ophthalmic solutions that were either not commercially available or not available in the higher concentrations needed. A survey was mailed to 125 hospital pharmacies and 125 community pharmacies in Oklahoma to determine the availability of extemporaneously prepared antibiotic ophthalmic solutions. Of 72 hospital pharmacies and 60 community pharmacies that responded, 17 hospital and 2 community pharmacies reported that they do compound these solutions. The main reasons given by the other pharmacies for not offering this service were the lack of a laminar flow hood or other equipment and lack of an aseptic environment. If extemporaneously prepared antibiotic ophthalmic solutions are needed to treat corneal ulcers, then pharmacists have a responsibility to prepare them. The recent publication of a handbook providing formulations for those products and the "ASHP Technical Assistance Bulletin on Pharmacy-Prepared Ophthalmic Products" may encourage more pharmacies to provide this needed service.

  3. THE PREPARATION AND STERILIZATION OF OPHTHALMIC SOLUTIONS

    PubMed Central

    Hogan, Michael J.

    1949-01-01

    Ophthalmic solutions should be prepared and preserved according to whether they are to be used in surgical procedures, in the clinic or office, or by the patient at home. There is an optimum pH level at which the solutions of individual drugs should be buffered in order to obtain the maximum efficiency and stability. Deterioration of the drugs used is greatly diminished when they are dispensed at the proper pH. Quaternary ammonium chloride solutions in proper strength have been shown to be adequate for the preservation of ophthalmic solutions. PMID:15408108

  4. Stability of pilocarpine ophthalmic solutions.

    PubMed

    Pilatti, C; Torre, M C; Chiale, C; Spinetto, M

    1999-06-01

    The stability of pilocarpine and pilocarpine-timolol eyedrop preparations available on the Argentine market was studied. A high-performance liquid chromatographic method that allows the estimation of pilocarpine in the presence of degradation products was used for the study according to the preestablished design. It was found that pilocarpine solutions are stable, while pilocarpine in association with timolol shows significant degradation.

  5. 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.

  6. 21 CFR 524.1200b - Kanamycin ophthalmic aqueous solution.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Kanamycin ophthalmic aqueous solution. 524.1200b... § 524.1200b Kanamycin ophthalmic aqueous solution. (a) Specifications. The drug, which is in an aqueous... kanamycin activity (as the sulfate) per milliliter of solution. (b) Sponsor. See No. 000856 in §...

  7. 21 CFR 524.1200b - Kanamycin ophthalmic aqueous solution.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Kanamycin ophthalmic aqueous solution. 524.1200b... § 524.1200b Kanamycin ophthalmic aqueous solution. (a) Specifications. The drug, which is in an aqueous... kanamycin activity (as the sulfate) per milliliter of solution. (b) Sponsor. See No. 000856 in §...

  8. 21 CFR 524.1200b - Kanamycin ophthalmic aqueous solution.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Kanamycin ophthalmic aqueous solution. 524.1200b... § 524.1200b Kanamycin ophthalmic aqueous solution. (a) Specifications. The drug, which is in an aqueous... kanamycin activity (as the sulfate) per milliliter of solution. (b) Sponsor. See No. 000856 in §...

  9. 21 CFR 524.1200b - Kanamycin ophthalmic aqueous solution.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Kanamycin ophthalmic aqueous solution. 524.1200b... § 524.1200b Kanamycin ophthalmic aqueous solution. (a) Specifications. The drug, which is in an aqueous... kanamycin activity (as the sulfate) per milliliter of solution. (b) Sponsor. See No. 000856 in §...

  10. Use of azithromycin ophthalmic solution in the treatment of chronic mixed anterior blepharitis.

    PubMed

    John, Thomas; Shah, Ami A

    2008-01-01

    We tested the efficacy of azithromycin ophthalmic solution for the treatment of chronic mixed anterior blepharitis. The findings suggest that patients with chronic mixed anterior blepharitis can be more effectively treated with azithromycin ophthalmic solution than erythromycin ophthalmic ointment. Patients treated with azithromycin ophthalmic solution show an extraordinary clinical response with shorter treatment duration.

  11. 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

  12. Ophthalmic regional blocks: management, challenges, and solutions.

    PubMed

    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

  13. Stability of fumagillin in an extemporaneously prepared ophthalmic solution.

    PubMed

    Abdel-Rahman, S M; Nahata, M C

    1999-03-15

    The stability of fumagillin 70 microg/mL (as the bicyclohexylammonium crystal) in an extemporaneously prepared ophthalmic solution was studied. An ophthalmic solution of fumagillin 70 microg/mL was prepared by combining 120 mg of fumagillin bicyclohexylammonium crystals with 20 mL of 0.9% Sodium Chloride Injection, USP, and 20 mL of an ophthalmic irrigating solution. The solution was stored in 12 sterile semi-opaque dropper bottles; 4 bottles were stored at 25 degrees C exposed to light, 4 were stored at 25 degrees C in the dark, and 4 were stored at 4 degrees C in the dark. Samples were taken on days 0, 7, 14, 21, and 28 and analyzed by high-performance liquid chromatography. Sterility was tested as well. In the solutions stored at 25 degrees C, 17-30% of the initial drug concentration was lost during the first week. The solution protected from light and stored at 4 degrees C lost about 12% of active drug by week 4. There was no change in color or odor in any of the solutions and only a minor change in pH over the study period. There was no evidence of microbial growth in any of the solutions tested. Fumagillin 70 microg/mL (as the bicyclohexylammonium crystal) in 0.9% sodium chloride injection and an ophthalmic irrigating solution containing benzalkonium chloride was stable in the dark for 14 days at 4 degrees C.

  14. Stability of acetylcysteine in an extemporaneously compounded ophthalmic solution.

    PubMed

    Anaizi, N H; Swenson, C F; Dentinger, P J

    1997-03-01

    The stability of acetylcysteine in an extemporaneously compounded ophthalmic solution was studied. Acetylcysteine 10% ophthalmic solution containing 0.025% disodium edetate and 0.5% chlorobutanol in an artificial tears base was prepared and stored at 2-8 degrees C in clear, 15-mL, low-density polyethylene dropper bottles. At 0, 7, 14, 21, 28, 35, and 60 days, a 1-mL sample was removed from each bottle and analyzed for acetylcysteine concentration by high-performance liquid chromatography. Another set of 10% acetylcysteine solutions containing 0.025%, 0.050%, 0.075%, or 0.10% disodium edetate were prepared, stored at room temperature (23-25 degrees C), and analyzed at 0, 7, 15, 30, 40, and 50 days. In the solutions containing 0.025% disodium edetate, acetylcysteine was stable for 60 days at 2-8 degrees C but for less than 7 days at 23-25 degrees C. In the solutions containing 0.75% and 0.10% disodium edetate, acetylcysteine was stable for 40 and 50 days, respectively, at 23-25 degrees C. Acetylcysteine in a 10% acetylcysteine ophthalmic solution containing 0.025% disodium edetate and 0.5% chlorobutanol in an artificial tears base was stable for 60 days at 2-8 degrees C.

  15. Testing the long term stability of vancomycin ophthalmic solution.

    PubMed

    McLellan, Christine; Ngo, Van; Pasedis, Sophia; Dohlman, Claes H

    2008-01-01

    Some patients with a keratoprosthesis (artificial cornea) are required to use prophylactic vancomycin ophthalmic solution daily for life to prevent infection, a regimen which has proven to be highly successful. The objective of this study was to determine whether such vancomycin solutions would remain stable at room temperature for an extended period of time, beyond that suggested by available published stability data and used in current practice. By relaxing the storage requirement and extending the expiration date of this solution, it was hoped that patient adherence and satisfaction would increase. The studied vancomycin ophthalmic solutions were compounded at the Massachusetts Eye and Ear Infirmary, Department of Pharmacy Services, Boston, Massachusetts, and were sent to an outside laboratory for high-performance liquid chromatography potency testing at predefined time points. Vancomycin 14-mg/mL ophthalmic solution compounded with 0.005% benzalkonium retains potency for at least 60 days at room temperature and 6 months frozen. Extending the beyond-use dating of vancomycin may lead to improved patient adherence by lowering costs and increasing convenience of storage and shipment of the medication.

  16. Randomized Comparison Between Rebamipide Ophthalmic Suspension and Diquafosol Ophthalmic Solution for Dry Eye After Penetrating Keratoplasty.

    PubMed

    Kobashi, Hidenaga; Kamiya, Kazutaka; Shimizu, Kimiya

    To compare the ocular surfaces of patients treated with rebamipide (REB) ophthalmic suspension or diquafosol (DQS) ophthalmic solution for dry eye syndrome after penetrating keratoplasty (PK). A total of 40 eyes of 40 patients who had dry eyes after undergoing PK were enrolled and randomly divided into an REB group and a DQS group. Both REB and DQS groups used each eye drop four times. The tear breakup time (TBUT), corneal fluorescein staining scores, and dry eye-related quality-of-life score (DEQS) were evaluated before treatment, 2 weeks after start of treatment and 4 weeks after start of treatment. We found a significant improvement in TBUT (P < 0.001, Dunnett's test) and fluorescein scores (P < 0.001) 4 weeks after treatment in the REB group. Similar results were obtained in the DQS group (P < 0.001 and P = 0.01, respectively). No significant improvements in DEQS were found 4 weeks after treatment in each group (P = 0.15 and P = 0.63, analysis of variance, respectively). No significant differences were seen in these variables and in the changes between the groups after treatment. REB and DQS may be effective for the management of dry eye syndrome after PK in terms of ocular surface findings. In our study, effects of REB appear to be equivalent to those of DQS in the patients.

  17. Stability studies on aqueous and oily ophthalmic solutions of diclofenac.

    PubMed

    Ahuja, Munish; Dhake, Avinash Shridhar; Sharma, Surendra Kumar; Majumdar, Dipak Kanti

    2009-04-01

    Various aqueous and oily diclofenac ophthalmic formulations were subjected to accelerated and long term stability studies. Degradation of diclofenac was found to follow first-order kinetics. Among the aqueous formulations containing preservative, formulation with PMA, PMN, SA, MP/PP and SMS showed diclofenac content above 90% after 6 months of accelerated and 12 months of room temperature storage. Diclofenac 0.1%, w/v aqueous formulation (pH 7.4), with 5-10% overages, containing SMS, MP/PP or PMN look promising taking both stability and corneal permeability in view. However, for use in cataract surgery formulation without preservative appears ideal. Oily ophthalmic formulations except those in olive and mustard oil, had more than 90% drug content after 6 months of accelerated and 12 months of room temperature storage. Diclofenac (0.2%, w/v) ophthalmic solution in sesame oil with 3% overage and containing benzyl alcohol (0.5%, v/v) as preservative, appears ideal, taking both stability and corneal permeability in view.

  18. Future of ophthalmic anti-infective therapy and the role of moxifloxacin ophthalmic solution 0.5% (VIGAMOX).

    PubMed

    Schlech, Barry A; Blondeau, Joseph

    2005-11-01

    The vintage antibiotics that were available in the 1950s-1980s were sometimes toxic, had limited spectra, and were bacteriostatic agents, and they have been replaced by significantly broader-spectrum therapies. We ask more of our future antibiotic products for ophthalmology: they must be 1) broad spectrum, 2) convenient to use, 3) useful prophylactically, 4) effective therapeutically, 5) benzalkonium chloride-free, 6) comfortable, and 7) nontoxic. The emergence of antibiotic resistance has focused us on more potent agents effective against resistant strains of bacteria. Fluoroquinolones have become a dominant family of ophthalmic antibiotics. But even the older fluoroquinolones (e.g., ofloxacin, ciprofloxacin) have lost much of their effectiveness against some important ocular isolates. Considering all of the characteristics for an ideal ophthalmic antibiotic product available today, moxifloxacin ophthalmic solution 0.5% represents a primary antibiotic product of choice for treating and preventing ophthalmic infections.

  19. 21 CFR 524.1484e - Neomycin and polymyxin B ophthalmic solution.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Neomycin and polymyxin B ophthalmic solution. 524.1484e Section 524.1484e Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... ANIMAL DRUGS § 524.1484e Neomycin and polymyxin B ophthalmic solution. (a) Specifications....

  20. Fixed drug eruption induced by topical olopatadine ophthalmic solution.

    PubMed

    Bilgili, S G; Karadag, A S; Karadag, R; Bulut, G; Calka, O

    2012-12-01

    Fixed drug eruption (FDE) usually develops after oral administration and is described as a cutaneous reaction recurring at the same location each time the drug is taken. Olopatadine is both a H1 histamine receptor antagonist and a mast cell stabilizer, indicated for the treatment of allergic conjunctivitis. Here, we report a 14-year-old male patient who developed FDE localised on the lateral side of periorbital rim bilaterally, whilst applying olopatadine 0.1% ophthalmic solution for the treatment of allergic conjunctivitis. As far as we know, FDE due to olopatadine has not been previously reported in the literature. We deem it appropriate to report this case because FDE that results from the application of topical drugs is a rare event in the literature.

  1. 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

    ... HUMAN SERVICES Food and Drug Administration Determination That XIBROM (Bromfenac Ophthalmic Solution) 0... (bromfenac ophthalmic solution) 0.09% was not withdrawn from sale for reasons of safety or effectiveness... ophthalmic solution 0.09% if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION...

  2. 21 CFR 524.1484e - Neomycin sulfate and polymyxin B sulfate ophthalmic solution.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS § 524.1484e Neomycin sulfate and polymyxin B sulfate ophthalmic solution. (a... nonsusceptible to the antibiotics incorporated in the drug. (4) Federal law restricts this drug to use by or...

  3. Assessment of bacterial contamination of three multidose ophthalmic solutions.

    PubMed

    Betbeze, Caroline M; Stiles, Jean; Krohne, Sheryl G

    2007-01-01

    To investigate the frequency of bacterial contamination of multidose proparacaine hydrochloride, tropicamide, and eyewash bottles used in veterinary ophthalmology examination rooms during normal operating procedures. Three representative bottles each of proparacaine hydrochloride, tropicamide, and purified water eye wash were opened at the same time, numbered, and placed into small animal examination rooms. Doctors, students and technicians who were using the solutions were blinded to the study. Aerobic cultures were obtained at the time of opening (time 0), at 1 week (time 1), and at 2 weeks after opening (time 2) the bottles. The sites cultured included a drop of each solution, the inside of the bottle cap, the tip of the bottle, and the bottle threads and medication residue found in these threads. Aerobic cultures of tropicamide and proparacaine had no growth of bacteria from any of the evaluated sites. Staphylococcus epidermidis was cultured from the tip of one bottle of eye wash after 1 week. We conclude that proparacaine, tropicamide, and eyewash solutions used in veterinary examination rooms are adequately preserved for use in ophthalmic examination. They have a low level of bacterial contamination 1 or 2 weeks after opening when used and stored according to the recommendations of the product manufacturers and previous studies.

  4. 21 CFR 524.1982 - Proparacaine ophthalmic solution.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... immediately before inserting catheter. (2) Indications for use. For use as a topical ophthalmic anesthetic. It is used as an anesthetic in cauterization of corneal ulcers, removal of foreign bodies and sutures... is indicated for use as a topical ophthalmic anesthetic in animals. It is used as an anesthetic in...

  5. Rate of bacterial eradication by ophthalmic solutions of fourth-generation fluoroquinolones.

    PubMed

    Callegan, Michelle C; Novosad, Billy D; Ramadan, Raniyah T; Wiskur, Brandt; Moyer, Andrea L

    2009-04-01

    Antibacterial activity of ophthalmic fourth-generation fluoroquinolones has traditionally been evaluated by comparing only their active ingredients, gatifloxacin and moxifloxacin. However, ophthalmic formulations of fourth-generation fluoroquinolones differ in terms of the inclusion of preservatives. While gatifloxacin ophthalmic solution 0.3% (Zymar; Allergan, Inc., Irvine, CA, USA) contains 0.005% benzalkonium chloride (BAK), moxifloxacin ophthalmic solution 0.5% (Vigamox; Alcon Laboratories, Inc., Fort Worth, TX, USA) is preservative-free. Recent studies have demonstrated that the presence of BAK dramatically affects the antibacterial activity of the ophthalmic formulation of gatifloxacin. This study was designed to compare the kill rates of ophthalmic solutions of fourth-generation fluoroquinolones against isolates of common ocular bacterial pathogens. Approximately 5.6 log(10) colony-forming units (CFU)/mL of Haemophilus influenzae (n=1), Streptococcus pneumoniae (n=1), Staphylococcus aureus (n=2), methicillin-resistant Staphylococcus aureus (MRSA) (n=4), methicillinresistant Staphylococcus epidermidis (MRSE) (n=4), and fluoroquinolone-resistant S. epidermidis (n=1) were incubated with ophthalmic solutions of either gatifloxacin or moxifloxacin. Viable bacteria were quantified at specific time points up to 60 minutes. Gatifloxacin 0.3% completely eradicated H. influenzae and Strep. pneumoniae in 5 minutes, one of two S. aureus isolates in 15 minutes, and the other S. aureus isolate in 60 minutes. Gatifloxacin 0.3% completely killed all MRSA, MRSE, and fluoroquinolone-resistant S. epidermidis isolates in 15 minutes. Moxifloxacin 0.5% completely eradicated Strep. pneumoniae and one of four MRSA isolates in 60 minutes. All other isolates incubated with moxifloxacin 0.5% retained viable bacteria ranging from 1.8 to 4.4 log(10) CFU/mL. The ophthalmic solution of gatifloxacin 0.3% eradicated bacteria that frequently cause postoperative ocular infections

  6. 21 CFR 524.1044a - Gentamicin ophthalmic solution.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS... in § 510.600(c) of this chapter. (c) Conditions of use. (1) The drug is used in dogs and cats for the...

  7. 21 CFR 524.1044a - Gentamicin ophthalmic solution.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS... in § 510.600(c) of this chapter. (c) Conditions of use. (1) The drug is used in dogs and cats for the...

  8. 21 CFR 524.1044a - Gentamicin ophthalmic solution.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS... in § 510.600(c) of this chapter. (c) Conditions of use. (1) The drug is used in dogs and cats for the...

  9. 21 CFR 524.1044a - Gentamicin 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... in § 510.600(c) of this chapter. (c) Conditions of use. (1) The drug is used in dogs and cats for the...

  10. 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...

  11. 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...

  12. 21 CFR 524.1982 - Proparacaine hydrochloride ophthalmic solution.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...) 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...

  13. 21 CFR 524.1982 - Proparacaine hydrochloride ophthalmic solution.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) 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...

  14. Olopatadine ophthalmic solution suppresses substance P release in the conjunctivitis models.

    PubMed

    Tamura, Tadafumi

    2012-04-01

    Olopatadine hydrochloride ophthalmic solutions are treated for allergic conjunctival diseases that are a selective histamine H1 receptor antagonist and an inhibitor of the release of mediators including histamine from the human mast cells. Substance P (SP) levels are increased in tears of patients with allergic conjunctivitis. However, little is known about the regulation of SP release by anti-allergic ophthalmic solutions. We investigated that the effect of olopatadine hydrochloride ophthalmic solutions (olopatadine 0.1% and olopatadine 0.2%) on rat conjunctivitis models compared with other anti-allergic ophthalmic solutions. Conjunctivitis was induced by subconjunctival injection of histamine or intravenous injection of ovalbumin in rats passively sensitized with anti-ovalbumin anti-serum. The releases of SP were determined in the conjunctiva and tears using rat antigen-induced conjunctivitis models. Olopatadine 0.1% and 0.2% significantly inhibited the increased conjunctival dye leaked in the histamine- or antigen-induced hyperpermeability. The inhibitory effects by olopatadine were more potent than by other tested anti-allergic ophthalmic solutions. Moreover, olopatadine significantly inhibited the release of SP from the conjunctiva. These results indicate that olopatadine ophthalmic solutions appear to exert additional SP release inhibition besides dual-action such as selective histamine H1 receptor antagonistic action and mast cell stabilization action.

  15. Olopatadine ophthalmic solution suppresses substance P release in the conjunctivitis models

    PubMed Central

    2012-01-01

    Background Olopatadine hydrochloride ophthalmic solutions are treated for allergic conjunctival diseases that are a selective histamine H1 receptor antagonist and an inhibitor of the release of mediators including histamine from the human mast cells. Substance P (SP) levels are increased in tears of patients with allergic conjunctivitis. However, little is known about the regulation of SP release by anti-allergic ophthalmic solutions. Objective We investigated that the effect of olopatadine hydrochloride ophthalmic solutions (olopatadine 0.1% and olopatadine 0.2%) on rat conjunctivitis models compared with other anti-allergic ophthalmic solutions. Methods Conjunctivitis was induced by subconjunctival injection of histamine or intravenous injection of ovalbumin in rats passively sensitized with anti-ovalbumin anti-serum. The releases of SP were determined in the conjunctiva and tears using rat antigen-induced conjunctivitis models. Results Olopatadine 0.1% and 0.2% significantly inhibited the increased conjunctival dye leaked in the histamine- or antigen-induced hyperpermeability. The inhibitory effects by olopatadine were more potent than by other tested anti-allergic ophthalmic solutions. Moreover, olopatadine significantly inhibited the release of SP from the conjunctiva. Conclusion These results indicate that olopatadine ophthalmic solutions appear to exert additional SP release inhibition besides dual-action such as selective histamine H1 receptor antagonistic action and mast cell stabilization action. PMID:22701861

  16. 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...) Limitations. Therapy for cats should not exceed 7 days. As with other antibiotics, prolonged use may result in... animals. The length of time that residues persist in milk or tissues has not been determined. Federal...

  17. Effect of textured eye drop bottles on the photostability of pranoprofen 0.1% ophthalmic solution.

    PubMed

    Iwatsuka, Kinya; Inada, Katsuhiro; Ueoka, Hiroki; Otsuka, Tadashi; Maeda, Masaki; Yamaguchi, Masazumi; Yasueda, Shin-ichi

    2015-01-01

    Ophthalmic solutions are usually filled in a plastic bottle due to its durability and disposability. In Japan, photostability is one of the concerns for the quality control because an eye drop bottle must be a transparent container. The present work studied the effect of textured eye drop bottles on its light blocking to improve the photostability of ophthalmic solutions. We investigated the photostability of Pranoprofen ophthalmic solution filled in a variety of textured eye drop bottles. Pranoprofen content was analyzed by high-performance liquid chromatography and surface structure of textured eye drop bottles was evaluated by transmittance, calculated average roughness (Ra) and haze intensity. We observed that eye drop bottle which had greater than Ra value of 1.0 µm and haze intensity 62% clearly showed photostability improvement. This report is the first one which shows that photostability of ophthalmic solution is improved by using textured eye drop bottle. Moreover, this approach is a simple and effective method to improve the photostability. This method is available for not only various ophthalmic applications but also other liquid pharmaceuticals or food products.

  18. 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.

  19. Association between moxifloxacin ophthalmic solution and fungal infection in patients with corneal ulcers and microbial keratitis.

    PubMed

    Mack, Robert J; Shott, Susan; Schatz, Scott; Farley, Sean J

    2009-06-01

    Fungal keratitis is a painful and dangerous fungal infection of the cornea. Recently, use of a contact lens solution with a novel ophthalmic preservative was linked to an increased risk of fungal keratitis. This study investigated whether fungal contamination was present in bottles of a widely used moxifloxacin ophthalmic solution, and whether there was an association between the use of this solution and fungal keratitis in a corneal referral practice. Fungal cultures were obtained for 32 moxifloxacin bottles brought in by 32 keratitis patients referred to our cornea practice from June 2003 to March 2006. Demographic and clinical data were also collected for 29 patients with fungal keratitis and 82 patients with bacterial keratitis, referred to our practice for corneal ulcers between June 2003 and April 2006. These two groups were compared with respect to moxifloxacin use and other variables. Logistic regression was carried out to determine whether an association between fungal keratitis and moxifloxacin use was present after taking into account potential confounding variables. Thirteen (41%) of the bottles of moxifloxacin solution grew fungus on culture. Patients with fungal keratitis were nearly twice as likely as patients with bacterial keratitis to report the use of moxifloxacin ophthalmic solution: 41% vs. 22% (P = 0.043). The association between fungal keratitis and moxifloxacin use persisted after taking into account potential confounding variables. Fungal contamination is present in the moxifloxacin bottles used by some keratitis patients. There appears to be an association between the use of moxifloxacin ophthalmic solution and fungal keratitis.

  20. 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

    ... HUMAN SERVICES Food and Drug Administration Determination That REV-EYES (Dapiprazole Hydrochloride... determined that REV-EYES (dapiprazole hydrochloride ophthalmic solution), 0.5%, was not withdrawn from sale... refer to a listed drug. REV-EYES (dapiprazole hydrochloride ophthalmic solution), 0.5%, is the...

  1. 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

    ...), 0.004%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug... (travoprost ophthalmic solution), 0.004%, was not withdrawn from sale for reasons of safety or effectiveness... ophthalmic solution, 0.004%, if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION...

  2. A comparison of the efficacy and tolerability of olopatadine hydrochloride 0.1% ophthalmic solution and cromolyn sodium 2% ophthalmic solution in seasonal allergic conjunctivitis.

    PubMed

    Katelaris, Constance H; Ciprandi, Giorgio; Missotten, Luc; Turner, F Darell; Bertin, Donata; Berdeaux, Gilles

    2002-10-01

    Treatments for allergic conjunctivitis have various mechanisms of action. Cromolyn sodium stabilizes conjunctival mast cells by preventing calcium influx across the cell membrane, whereas olopatadine hydrochloride is both an antihistamine and a mast cell stabilizer. This study compared the efficacy and tolerability of olopatadine and cromolyn in controlling the ocular signs and symptoms of seasonal allergic conjunctivitis. This was a multicenter, randomized, double-masked, parallel-group trial. One group instilled olopatadine 0.1% ophthalmic solution and placebo BID, and the other instilled cromolyn 2% ophthalmic solution QID, both for 6 weeks. The formulation of cromolyn used in this study is currently available only in Europe and Australia. The intent-to-treat efficacy and safety analyses included 185 patients, 91 in the olopatadine group and 94 in the cromolyn group. At 30 minutes after the first instillation, respective decreases of approximately 30% and approximately 20% were reported in self-rated ocular itching and redness with both treatments; by 4 hours, itching had decreased by approximately 38% in both groups. Differences between treatments were not statistically significant. At 4 hours, redness had decreased by approximately 38% and approximately 26% in the respective treatment groups. By day 42, both treatments had produced significant reductions from baseline in ocular signs and symptoms; however, the reductions in itching and redness were significantly greater with olopatadine compared with cromolyn (both variables, P < 0.05). The difference in physicians' impression of overall improvement on days 30 and 42 significantly favored olopatadine over cromolyn (both days, P < 0.05). Most patients (62.2%) had reacted positively to grass pollen at baseline. The regression slopes correlating itching and redness with pollen count were 5 times lower for olopatadine compared with cromolyn (P = 0.002 and P = 0.016, respectively), indicating that olopatadine

  3. 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.

  4. Gatifloxacin Ophthalmic

    MedlinePlus

    Gatifloxacin ophthalmic solution is used to treat bacterial conjunctivitis (pinkeye; infection of the membrane that covers the outside ... contact lenses while you have symptoms of bacterial conjunctivitis or while you are applying eye drops. you ...

  5. Review of Azithromycin Ophthalmic 1% Solution (AzaSite®) for the Treatment of Ocular Infections

    PubMed Central

    Opitz, Dominick L.; Harthan, Jennifer S.

    2012-01-01

    AzaSite® (azithromomycin 1.0%) ophthalmic solution was approved in 2007 by the US Food and Drug Administration (FDA) as the first commercially available formulation of ophthalmic azithromycin for the treatment of bacterial conjunctivitis. AzaSite® utilizes a vehicle delivery system called DuraSite®, which stabilizes and sustains the release of azithromycin to the ocular surface, leading to a longer drug residence time, less frequent dosing, and an increase in patient compliance. AzaSite® is a broad spectrum antibiotic, effective against Gram-positive, Gram-negative, and atypical bacteria. AzaSite® has been studied for the treatment of ocular conditions beyond its clinical indication. A number of clinical studies have evaluated its efficacy and safety in the management of ocular conditions such as bacterial conjunctivitis and blepharitis on both the pediatric and adult populations. This article aims to evaluate the peer-reviewed published literature on the use of azithromycin 1.0% ophthalmic for current and possible future ophthalmic uses. PMID:23650453

  6. Impact of deep freezing on the stability of 25 mg/ml vancomycin ophthalmic solutions.

    PubMed

    Sautou-Miranda, V; Libert, F; Grand-Boyer, A; Gellis, C; Chopineau, J

    2002-03-02

    For the treatment of certain eye infections, ophthalmic solutions 'laced' with 25 mg/ml vancomycin are sometimes prepared. Their physical and chemical stability and the maintenance of their sterility were studied after deep freezing at -20 +/- 2 degrees C and thawing, followed or not by refrigeration for 48 h at 4 +/- 2 degrees C. Physical and chemical analysis comprised visual inspection turbidity, determination of pH and osmolality, and assay of vancomycin by high performance liquid chromatography with ultraviolet detection. For microbiological analysis a 25 mg/ml vancomycin ophthalmic solution was filtered through two membranes and cultured on trypticase-soy and Sabouraud-glucose solid media. Any colonies were then counted. These physical, chemical and microbiological analyses demonstrated the stability of 25 mg/ml vancomycin ophthalmic solutions in 5% glucose deep frozen at -20 +/- 2 degrees C for 3 months. The vancomycin concentration varied by no more than 5% of the initial concentration, and no breakdown product was evidenced. Neither pH (mean=3.8 +/- 0.1) nor osmolality (mean=318.3 +/- 5.6 mOsm/kg) varied significantly, and remained compatible with intraocular administration. No particle or bacterial combination was found in the course of the study. The thawing procedure (at ambient temperature or under warm running water from a tap) did not modify the stability of the eye drops. Likewise, storage in a refrigerator for 48 h after thawing did not modify stability. The advantage of storing vancomycin 25 mg/ml ophthalmic solutions for 3 months in deep freeze is that a stock of chemically and microbiologically controlled preparations can be held ready for administration to patients, thereby allowing prompter dispensing, as the eye drops are not made up extemporaneously, while the improved control over production ensures that patients receive solutions of constant quality, as every batch prepared is systematically inspected.

  7. Stability of vancomycin in an extemporaneously compounded ophthalmic solution.

    PubMed

    Fuhrman, L C; Stroman, R T

    1998-07-01

    The stability of vancomycin 31 mg/mL (as the hydrochloride) in an artificial tears solution at -10, 4, 25, and 40 degrees C was studied. Vancomycin power was reconstituted with sterile water for injection to a concentration of 50 mg/mL. Artificial tears solution containing 0.3% hydroxypropyl methylcellulose, 0.1% dextran 70, 0.01% benzalkonium chloride, and 0.05% edetate disodium was used to produce a final concentration of 31 mg/mL. Triplicate solutions for each storage temperature and sampling time were prepared. The solutions were stored at -10, 4, 25, and 40 degrees C. Samples were taken initially and at 3, 7, 10, 21, 30, 45, and 60 days for visual inspection and analysis by high-performance liquid chromatography. All solutions remained clear and colorless at -10, 4, and 25 degrees C throughout the study period. By day 3, crystalline particles formed in the solutions stored at 40 degrees C. No substantial change in pH was observed at any time. At -10 degrees C, the solutions retained more than 90% of their initial vancomycin concentrations throughout the study period. The solutions retained a mean of at least 90% of the initial drug concentration for 21 days at 4 degrees C and for 7 days at 25 degrees C. For the solutions stored at 25 or 40 degrees C, less than 85% of the initial vancomycin concentration remained after 10 and 3 days, respectively. Vancomycin 31 mg/mL (as the hydrochloride) in an artificial tears solution was stable for 45 days at -10 degrees C, 10 days at 4 degrees C, and 7 days at 25 degrees C in the tears solution's original container.

  8. 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.

  9. Sedative and physiological effects of brimonidine tartrate ophthalmic solution in healthy cats.

    PubMed

    Ogata, Niwako; Kanda, Teppei; Kawahata, Mizuki; Ichikawa, Takayasu; Matsumoto, Yuki; Morimitsu, Waka; Nishino, Yukiko; Itoi, Takamasa; Furumoto, Kayo

    2017-07-03

    To determine the effects of brimonidine tartrate ophthalmic solution on sedation, heart rate (HR), respiratory frequency (fR), rectal temperature (RT) and noninvasive mean arterial pressure (MAP) in healthy cats. Randomized, blinded crossover study, with 1 week washout between treatments. Six healthy purpose-bred cats. Brimonidine tartrate ophthalmic solution 0.1% (one or two drops; 58.6 ± 3.3 μg per drop) or a control solution (artificial tear solution) was administered to six healthy cats. Behavioural observations and measurements of HR, fR, RT and MAP were recorded before and at 30, 60, 90, 120, 180, 240, 300 and 360 minutes after topical administration. Behavioural scores were analysed using Friedman's test for repeated measures to evaluate the time effect in each treatment and treatment effect at each time point. Physiological variables (HR, fR, RT and MAP) were analysed using two-way analysis of variance for repeated measures to evaluate the time and treatment effects. The level of significance was set at p < 0.05. Dose-dependent behavioural and physiological responses were noted. A dose of two drops of brimonidine resulted in sedation in the cats and decreased HR and MAP. Significant sedative effects occurred between 30 and 120 minutes and for physiological responses up to 360 minutes. The most frequent adverse reaction was vomiting, occurring within 40 minutes in all six cats administered two drops and five of the six cats administered one drop of brimonidine. The results demonstrated that ocular administration of brimonidine 0.1% ophthalmic solution induced sedation in cats and some cardiovascular effects usually associated with α2-adrenoceptor agonists. Further studies should be performed to determine clinical applications for this agent in cats. Copyright © 2017 Association of Veterinary Anaesthetists and American College of Veterinary Anesthesia and Analgesia. Published by Elsevier Ltd. All rights reserved.

  10. Evaluation of analgesic efficacy of bromfenac sodium ophthalmic solution 0.09% versus ketorolac tromethamine ophthalmic solution 0.5% following LASEK or Epi-LASIK

    PubMed Central

    Wang, Xiao Jing; Wong, Sze H; Givergis, Roshan; Chynn, Emil W

    2011-01-01

    Background To evaluate the analgesic efficacy of bromfenac sodium ophthalmic solution 0.09% compared with ketorolac tromethamine ophthalmic solution 0.5% in laser epithelial keratomileusis (LASEK) or epithelial keratomileusis (epi-LASEK), sometimes referred to as epi-LASIK. Methods Eighty eyes (from 40 patients, 18 men and 22 women) undergoing bilateral simultaneous LASEK or epi-LASEK were randomized to receive ketorolac in one eye and bromfenac in the other. Mean age was 33.13 ± 9.34 years. One drop of bromfenac or ketorolac was instilled in each eye 15 minutes and one minute prior to surgery, and two and four hours following surgery. Patients were instructed to instill the medications on-label each day through postoperative day 4. The subjects completed pain and visual blurriness assessments from day of surgery to postoperative day 4. Uncorrected visual acuity was tested on postoperative days 1 and 6. Results For each of the five days, pain scores for bromfenac-treated eyes were significantly less than that for ketorolac-treated eyes (P < 0.01). Of the 40 patients, 32 (80%) said bromfenac provided better postoperative analgesia than ketorolac. There was no statistically significant difference in visual blurriness scores between the two groups (P > 0.1). Uncorrected visual acuity did not vary significantly between the treatment groups (P > 0.1). No serious adverse events were noted. Conclusion Bromfenac is subjectively superior to ketorolac in reducing postoperative pain following LASEK or epi-LASEK. The subjects tolerated the drugs well with no serious adverse outcomes and no difference in uncorrected visual acuity. PMID:22034570

  11. Evaluation of the cytotoxic effects of ophthalmic solutions containing benzalkonium chloride on corneal epithelium using an organotypic 3-D model

    PubMed Central

    Khoh-Reiter, Su; Jessen, Bart A

    2009-01-01

    Background Benzalkonium chloride (BAC) is a common preservative used in ophthalmic solutions. The aim of this study was to compare the cytotoxic effects of BAC-containing ophthalmic solutions with a BAC-free ophthalmic solution using an organotypic 3-dimensional (3-D) corneal epithelial model and to determine the effects of latanoprost ophthalmic solution and its BAC-containing vehicle on corneal thickness in a monkey model. Methods The cytotoxicity of commercially available BAC-containing ophthalmic formulations of latanoprost (0.02% BAC) and olopatadine (0.01% BAC) was compared to that of BAC-free travoprost and saline in a corneal organotypic 3-D model using incubation times of 10 and 25 minutes. To compare the extent of differentiation of 3-D corneal cultures to monolayer transformed human corneal epithelial (HCE-T) cell cultures, expression levels (mRNA and protein) of the corneal markers epidermal growth factor receptor, transglutaminase 1 and involucrin were quantified. Finally, latanoprost ophthalmic solution or its vehicle was administered at suprapharmacologic doses (two 30 μL drops twice daily in 1 eye for 1 year) in monkey eyes, and corneal pachymetry was performed at baseline and at weeks 4, 13, 26 and 52. Results In the 3-D corneal epithelial culture assays, there were no significant differences in cytotoxicity between the BAC-containing latanoprost and olopatadine ophthalmic solutions and BAC-free travoprost ophthalmic solution at either the 10- or 25-minute time points. The 3-D cultures expressed higher levels of corneal epithelial markers than the HCE-T monolayers, indicating a greater degree of differentiation. There were no significant differences between the corneal thickness of monkey eyes treated with latanoprost ophthalmic solution or its vehicle (both containing 0.02% BAC) and untreated eyes. Conclusion The lack of cytotoxicity demonstrated in 3-D corneal cultures and in monkey studies suggests that the levels of BAC contained in ophthalmic

  12. 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.

  13. Local toxicity of benzalkonium chloride in ophthalmic solutions following repeated applications.

    PubMed

    Okahara, Akihiko; Kawazu, Kouichi

    2013-01-01

    We performed repeated toxicity studies of benzalkonium chloride (BAK)-containing vehicles of ophthalmic solutions in monkeys and rabbits to assess the local toxicity of BAK after repeated applications on the ocular surface. Local toxicity of BAK was evaluated by toxicity studies in which a 0.01% BAK-containing vehicle was applied twice/day for 52 weeks, 4 times/day for 39 weeks, or 6 times/day for 13 weeks, or in which a 0.005% BAK-containing vehicle was applied 6 times/day for 52 weeks or twice/day for 4 weeks in monkeys. Local toxicity of BAK was also evaluated where a 0.01% BAK-containing vehicle was applied 6 times/day for 6 weeks, or a 0.005% BAK-containing vehicle was applied twice/day for 39 weeks or 8 times/day for 4 weeks in rabbits. These doses were chosen because BAK is generally used at concentrations up to 0.01% in ophthalmic solutions. The BAK-containing vehicle did not cause ophthalmological changes suggestive of irritation, allergy, or corneal damage. We also did not observe any histopathological changes in the eyeball, eyelid, lacrimal gland, and nasal cavity, with repeated applications of BAK for up to 52 weeks, up to 8 times/day, or at concentrations up to 0.01%, in monkeys and rabbits. Our results suggest that BAK in concentrations up to 0.01% in ophthalmic solution is non-toxic to the eyeball, its accessory organs, and the nasal cavity after long repeated applications.

  14. Effect of pirenzepine ophthalmic solution on form-deprivation myopia in the guinea pigs.

    PubMed

    Le, Qi-hua; Cheng, Neng-neng; Wu, Wei; Chu, Ren-yuan

    2005-04-05

    Nonselective muscarinic receptor antagonist, atropine, was believed to inhibit myopic progression. The purpose of this study was to determine the efficacy, through topical administration, of the M1-selective muscarinic antagonist pirenzepine in preventing experimentally induced form-deprivation myopia in guinea pigs. Fifty-three guinea pigs, which underwent monocular deprivation with their eyelids sutured, were divided into 6 groups. Three groups were treated with 1%, 2% or 4% pirenzepine ophthalmic solutions; the fourth group with atropine; the fifth with saline and the last group left untreated. Ocular refraction, in vivo biometric measurements and wet eye weight were collected before and after the experiment. All the eyes were finally enucleated for histopathological examination to evaluate the possible toxic effects on ocular structures. Animals untreated or treated with saline produced (-2.31+/-1.47) D and (-2.25+/-0.88) D of axial myopia respectively. Those treated with 1% pirenzepine ophthalmic solution produced relative myopia of (-1.63+/-0.48) D, and those under the treatment of 2% and 4% pirenzepine ophthalmic solution only developed a relative myopia of (-0.89+/-0.42) D and (-0.70+/-0.41) D (F=9.56, P<0.05). The significant reduction in myopia in 2% and 4% pirenzepine treated animals was caused by significantly less vitreous chamber elongation and axial elongation of the deprived eyes [2% group: (0.009+/-0.052) mm, 4% group: (0.006+/-0.078) mm] when compared with untreated, saline treated or 1% pirenzepine treated guinea pigs (0.057+/-0.056) mm, (0.064+/-0.053) mm and (0.033+/-0.035) mm, respectively]. Histological examinations revealed no obviously toxic effects on the eyes treated with pirenzepine. Topical administration of the M1-selective muscarinic antagonist, pirenzepine, can prevent induced form-deprivation myopia in guinea pigs by inhibiting axial elongation without obvious damage to ocular tissues.

  15. Efficacy of azithromycin 1% ophthalmic solution for treatment of ocular surface disease from posterior blepharitis.

    PubMed

    Opitz, Dominick L; Tyler, Keith F

    2011-03-01

    Posterior blepharitis is an eyelid disease primarily of the meibomian glands. Bacteria and chronic inflammation are contributing factors for meibomian gland disease, which leads to ocular surface and tear film alterations and chronic patient symptoms. Azithromycin 1.0% ophthalmic solution is a broad spectrum topical antibiotic with anti-inflammatory properties. The present study evaluates the efficacy of azithromycin 1.0% ophthalmic solution in the treatment of the clinical signs and symptoms, including vision-related function, associated with meibomian gland dysfunction. In an open label study, 33 patients with meibomian gland dysfunction were treated with azithromycin 1.0% ophthalmic solution twice a day for two days, then every evening for a total of 30 days. Tear break-up time, corneal staining, conjunctival staining, Schirmer scores with anaesthetic, meibomian gland score and patient's symptom scores were evaluated at baseline and after 30 days of treatment. The Ocular Surface Disease Index (OSDI) was administered at baseline, after two weeks of treatment and after 30 days of treatment. Twenty-six of 33 patients completed the study. Tear break-up time and Schirmer score increased by 52.7 per cent (p < 0.0001) and 24 per cent (p < 0.05), respectively. There was a reduction in corneal and conjunctival staining by 83.2 and 67.9 per cent, respectively (p < 0.0001). Lid margin scores were reduced by 33.9 per cent (p < 0.0001). The patient's symptom score improved from 2.73 at baseline to 2.21 after 30 days of treatment (p < 0.01). The mean OSDI at baseline was 34.44. After two weeks and 30 days of treatment, the ODSI was 14.51 and 13.15 respectively (p < 0.0001). These results demonstrate clinically and statistically significant improvement in the signs and symptoms associated with posterior blepharitis. Based on these results, azithromycin 1% ophthalmic solution offers a viable option for the treatment of posterior blepharitis. © 2010 The Authors. Clinical and

  16. A comparison of the clinical efficacy of pheniramine maleate/naphazoline hydrochloride ophthalmic solution and olopatadine hydrochloride ophthalmic solution in the conjunctival allergen challenge model.

    PubMed

    Greiner, Jack V; Udell, Ira J

    2005-05-01

    The signs and symptoms of allergic conjunctivitis include ocular redness and itching. Two treatment options currently indicated for acute ocular allergic reaction are pheniramine maleate 0.3%/naphazoline hydrochloride 0.025% ophthalmic solution, an over-the-counter antihistamine/vasoconstrictor combination; and olopatadine hydrochloride 0.1% ophthalmic solution, a prescription antihistamine/mast cell stabilizer. This study was designed to compare, at onset of action, the relative effectiveness of pheniramine/naphazoline and olopatadine, when administered before conjunctival allergen challenge (CAC), using the ocular allergy index (OAI) as the primary end point. This was a prospective, randomized, double-masked, contralateral, active- and placebo-controlled, single-center study of the CAC model. The first 2 study visits established and confirmed the subjects' ocular allergic reaction (no medication administered). At visit 3, the subjects were randomly assigned to 1 of 3 contralateral (right eye vs left eye) treatment combinations: pheniramine/naphazoline + olopatadine, pheniramine/naphazoline + placebo, or olopatadine + placebo. Medication was given 10 minutes before CAC. The subjects' erythema in the ciliary, conjunctival, and episcleral vessel beds; eyelid swelling; chemosis; and itching were evaluated at 7, 12, and 20 minutes after CAC. The OAI was calculated as a composite score of 6 signs and symptoms of allergic conjunctivitis to assess global severity. Between-treatment differences in OAI scores were used to evaluate efficacy. Subjects were asked their eye drop preference at the conclusion of visit 3. Subjects (n = 83) ranged in age from 20 to 70 years (mean, 42.5 years), 61.4% (n = 51) were female, and 94.0% (n = 78) were white. Both pheniramine/naphazoline and olopatadine were associated with significantly lower OAI scores than placebo at all 3 time points (all, P < 0.001). OAI scores were significantly lower with pheniramine/naphazoline than with

  17. Evaluation of the efficacy of olopatadine hydrochloride 0.1% ophthalmic solution and azelastine hydrochloride 0.05% ophthalmic solution in the conjunctival allergen challenge model.

    PubMed

    Spangler, D L; Bensch, G; Berdy, G J

    2001-08-01

    Olopatadine hydrochloride 0.1% ophthalmic solution and azelastine hydrochlofide 0.05% ophthalmic solution are 2 topical antiallergic agents indicated for the treatment of itching of the eye associated with allergic conjunctivitis. Olopatadine has recently received US Food and Drug Administration (FDA) approval for an expanded indication for the treatment of signs and symptoms of allergic conjunctivitis, including itching, tearing, eyelid swelling, redness, and chemosis. The purpose of this study was to compare the efficacy of olopatadine hydrochloride versus azelastine hydrochloride and placebo (artificial tears) in the conjunctival allergen challenge (CAC) model. This was a prospective, randomized, double-masked, contralaterally controlled, multicenter, allergen-challenge study. Itching was chosen as the primary efficacy variable since it is the only FDA-approved indication these 2 agents have in common. Subjects with a history of allergic conjunctivitis who responded to the CAC at screening visits 1 and 2 were randomized to 1 of 3 treatment groups: olopatadine in 1 eye and azelastine in the other eye; olopatadine in 1 eye and placebo in the other eye; or azelastine in 1 eye and placebo in the other eye. At the assessment visit (visit 3), subjects received masked study medication according to the randomization scheme. After 5 minutes, subjects were bilaterally challenged with the allergen concentration that had elicited a positive conjunctival allergic response at visits 1 and 2. Immediately after challenge, subjects gave itching assessments (scale, 0 = no itching to 4 = severe itching) every 30 seconds for a total period of 20 minutes. Mean itching scores for all eyes were compared by treatment. Mean itching scores at each time point were compared between treatments using 2 sample t tests. Of the 180 subjects screened, 111 responded to the CAC at visits 1 and 2 and completed the study; 65% (72/111) of patients were female, 87% (97/111) were white, and 49% (54

  18. Self-medicated over the counter ophthalmic solutions in central Bangkok.

    PubMed

    Tayanithi, Pakitti; Aramwit, Pornanong

    2005-09-01

    There is a paucity of research about patients' attitudes, motivations and expectations towards self-medicated over the counter (OTC) ophthalmic solutions. To identify the attitudes, motivations and expectations of general population towards self-medicated OTC ophthalmic solutions. 200 consecutive participants who were studying or lived in Patumwan District of Bangkok filled in a questionnaire in a 3-months period. 67.5% (135/200) of the participants had an age range of 15-24 years old and 32.5% (65/200) were between 25-35 years old. Participants who were university graduates and currently university students were 53% and 35.5% respectively. Most history of illness was allergy (10/200). Half of the participants had normal vision and 40% (80/200) were near-sighted. The factor that most influenced the use of solution was dust in the eye (55%-111/200). Ocular allergic symptoms, such as eye itching, irritation and tearing, was the second. The most frequent symptom that induced the use of solutions was eye itching and irritation (48.5%-97/200). The symptom of red or pink eye was the second (33%-66/200). 48.5% (97/200) and 53.50% (107/200) of participants started using the solution at the time the influencing symptoms occurred and used for one day respectively. 46.5% (93/200) of the participants realized that the solution could be use only within 1 month after opening. From the data of this survey, more information and knowledge about the use of OTC products needs to be campaigned, even among highly educated citizens in the center of Bangkok. Better information for patients could improve the safety of OTC medicines. The ways of advising patients need to be found. The uncertainty is, therefore, how far this trend will go and how health care professionals and consumers will resspond.

  19. Quantitative analysis of chondroitin sulfate in raw materials, ophthalmic solutions, soft capsules and liquid preparations.

    PubMed

    Sim, Joon-Soo; Jun, Gyungjin; Toida, Toshihiko; Cho, So Yean; Choi, Don Woong; Chang, Seung-Yeup; Linhardt, Robert J; Kim, Yeong Shik

    2005-04-25

    We performed the quantitative analysis of chondroitin sulfate (CS) obtained from raw materials and various pharmaceutical preparations. To quantify CS content in raw materials and in an ophthalmic solution, each test sample and the authentic CS were first digested by chondroitinase ABC. The CS disaccharides produced were analyzed by strong anion-exchange high-performance liquid chromatography (SAX-HPLC) and CS content was quantified by calculating the total peak areas of the disaccharides derived from a CS calibration curve. In the case of soft capsules, CS was first extracted with hexane followed by phenol-chloroform to remove oil and protein ingredients. The extracted CS samples were depolymerized by chondroitinase ABC and CS content was determined. Quantitative analysis of the disaccharides derived from raw materials and an ophthalmic solution showed the CS contents (%) were 39.5+/-0.1 to 105.6+/-0.1 and 103.3+/-1.2, respectively. In case of CS analysis in soft capsules and liquid preparations, the overall recovery (%) of the spiked CS was 96.79+/-0.53-103.54+/-1.78 and 97.10+/-1.82 to 103.17+/-2.34, respectively. In conclusion, the quantitative analysis of the disaccharides produced by enzymatic digestion can be used in the direct quantitation of CS containing pharmaceutical formulations.

  20. Efficacy of topical azithromycin ophthalmic solution 1% in the treatment of posterior blepharitis.

    PubMed

    Luchs, Jodi

    2008-09-01

    Azithromycin, a broad-spectrum antibiotic with potent anti-inflammatory activities, has the potential to effectively treat blepharitis, an inflammatory disease of the eyelid with abnormal eyelid flora as an etiologic determinant. The present study compared the efficacy of topical azithromycin ophthalmic solution 1% (AzaSite; Inspire Pharmaceuticals, Inc, NC, USA) combined with warm compresses (azithromycin group) to warm compresses alone (compress group) in patients with posterior blepharitis. Twenty-one patients diagnosed with posterior blepharitis were randomized in an open-label study to receive either azithromycin plus warm compresses (10 patients), or compresses alone (11 patients). All patients were instructed to apply compresses to each eye for 5-10 minutes twice daily for 14 days. Each eye in the azithromycin group also received azithromycin solution (1 drop) twice daily for the first 2 days followed by once daily for the next 12 days. Patients were evaluated at study initiation (visit 1) and at end of treatment (visit 2) for the severity of five clinical signs: eyelid debris, eyelid redness, eyelid swelling, meibomian gland (MG) plugging, and the quality of MG secretion. At visit 2, patients also rated their degree of overall symptomatic relief. Twenty patients completed the study. At visit 2, patients in the azithromycin group demonstrated significant improvements in MG plugging, MG secretions, and eyelid redness as compared with the compress group. In the azithromycin group, MG plugging resolved completely in three patients and MG secretion returned to normal in two patients; no such results were seen in the compress group. Furthermore, a higher percentage of patients in the azithromycin group rated overall symptomatic relief as excellent or good. Visual acuity measurements and biomicroscopic evaluation revealed no ocular safety issues. Azithromycin ophthalmic solution in combination with warm compresses provided a significantly greater clinical benefit

  1. Review of moxifloxacin hydrochloride ophthalmic solution in the treatment of bacterial eye infections

    PubMed Central

    Miller, Darlene

    2008-01-01

    Moxifloxacin hydrochloride ophthalmic solution 0.5% (Vigamox®) is the ocular formulation/adaptation of moxifloxacin. Moxifloxacin is a broad spectrum 8-methoxyfluoroquinolone which terminates bacterial growth by binding to DNA gyrase (topoisomerase II) and topoisomerase IV, essential bacterial enzymes involved in the replication, translation, repair and recombination of deoxyribonucleic acid. Affinity for both enzymes improves potency and reduces the probability of selecting resistant bacterial subpopulations. Vigamox is a bactericidal, concentration dependent, anti-infective. It is preservative free, and well tolerated with minimal ocular side effects. It provides increased penetration into ocular tissues and fluids with improved activity against Streptococci and Staphylococci species and moderate to excellent activity against clinically relevant, gram-negative ocular pathogens. PMID:19668391

  2. 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.

  3. Once daily dosing of bromfenac ophthalmic solution 0.09% for postoperative ocular inflammation and pain.

    PubMed

    Silverstein, Steven M; Cable, Melissa G; Sadri, Ehsan; Peace, James H; Fong, Raymond; Chandler, Simon P; Gow, James A; Klier, Sharon M; McNamara, Timothy R

    2011-09-01

    To evaluate the efficacy and ocular safety of bromfenac ophthalmic solution 0.09% dosed once daily for the treatment of ocular inflammation and pain following cataract extraction with posterior chamber intraocular lens implantation. A total of 455 subjects (455 study eyes: 230 bromfenac, 225 placebo) were enrolled in two randomized double-masked, placebo-controlled, clinical trials at 64 ophthalmology clinics in the United States. Subjects were randomized to receive either bromfenac 0.09% or placebo dosed once daily. Dosing began 1 day before cataract surgery (Day -1), continued on day of surgery (Day 0), and for 14 days following surgery. Evaluations were completed on Days 1, 3, 8, 15 and 22. The primary efficacy endpoint was cleared summed ocular inflammation score (SOIS) by Day 15. The secondary efficacy endpoint was the number of subjects who were pain-free at Day 1. The bromfenac 0.09% group was significantly higher compared to the placebo group in the primary endpoint of the proportion of subjects who had cleared ocular inflammation by Day 15 (P < 0.0001). The mean SOIS for the bromfenac 0.09% group was lower than the placebo group at Days 3, 8, 15, and 22 (P < 0.0001). More bromfenac 0.09% subjects were pain free at Days 1, 3, 8, and 15 (P < 0.0001). Fewer subjects in the bromfenac 0.09% group withdrew from the clinical trials due to lack of efficacy at Day 15 (P < 0.0001). Fewer adverse events were reported in the bromfenac 0.09% group than the placebo group. Limitations included advanced age, female predominance, and surgical nuances among cataract surgeons, making cross-trial comparisons difficult. Bromfenac ophthalmic solution 0.09% dosed once daily is clinically safe and effective for the treatment of ocular inflammation and the reduction of ocular pain associated with cataract surgery.

  4. Efficacy of olopatadine ophthalmic solution 0.2% in reducing signs and symptoms of allergic conjunctivitis.

    PubMed

    Abelson, Mark B; Gomes, Paul J; Pasquine, Terri; Edwards, Michael R; Gross, Robert D; Robertson, Stella M

    2007-01-01

    Olopatadine hydrochloride ophthalmic solution 0.2% (Pataday, Alcon) is a new formulation of olopatadine hydrochloride ophthalmic solution, the first topical ocular antiallergic agent indicated for once-daily dosing. The aim of this study was to evaluate the safety, efficacy, onset, and duration of action of olopatadine 0.2% in the treatment of allergic conjunctivitis. Using the conjunctival allergen challenge, this double-masked, randomized by eye, parallel-group study included four visits over a 5-week period. Subjects were screened for eligibility (visit 1) and their ocular allergic responses were confirmed at visit 2. The efficacy of olopatadine in reducing the signs and symptoms of allergic conjunctivitis was evaluated at onset of action (visit 4) and 16 hours (visit 3) after masked medication instillation. The primary efficacy parameter was ocular itching. Safety parameters were also evaluated. Ninety subjects were evaluated. Olopatadine 0.2% was significantly (p < 0.001) more effective than placebo in the treatment of ocular itching at all time points at both the onset of action and the 16-hour allergen challenges. Olopatadine 0.2% was significantly (p < 0.03) more effective than placebo in the reduction of conjunctival redness, chemosis, and eyelid swelling at all time points (with the exception of conjunctival redness, which was significantly reduced at five of six time points). There were no serious adverse events and no treatment-related adverse events. Once-daily dosing with olopatadine 0.2% reduced the signs and symptoms of allergic conjunctivitis with a rapid and prolonged duration of action. Safety analyses indicated that olopatadine 0.2% was safe and well tolerated in subjects with a history of allergic conjunctivitis.

  5. Efficacy and safety of diquafosol ophthalmic solution in patients with dry eye syndrome: a Japanese phase 2 clinical trial.

    PubMed

    Matsumoto, Yukihiro; Ohashi, Yuichi; Watanabe, Hitoshi; Tsubota, Kazuo

    2012-10-01

    To investigate the dose-dependent efficacy and safety of diquafosol ophthalmic solution for the treatment of dry eye syndrome. Randomized, double-masked, multicenter, parallel-group, placebo-controlled trial. A total of 286 Japanese patients with dry eye who were prescribed topical diquafosol (1%, n = 96; 3%, n = 96) or placebo ophthalmic solution (n = 94). After a washout period of 2 weeks, qualified subjects were randomized to receive a single drop of 1% or 3% diquafosol or placebo ophthalmic solutions 6 times per day for 6 weeks. The primary outcome measure was fluorescein corneal staining score assessment. The secondary outcome measures were Rose Bengal corneal and conjunctival staining scores, tear break-up time (BUT), and subjective symptom assessment. Safety measures were clinical blood and urine examination and recording of adverse events. Fluorescein corneal staining scores significantly improved with both 1% and 3% topical diquafosol compared with placebo at 4 weeks, respectively (P = 0.037, P = 0.002). There was a dose-dependent effect among the groups. Rose Bengal corneal and conjunctival staining scores also improved significantly with both 1% and 3% diquafosol compared with placebo (P = 0.007 and P = 0.004, respectively). Subjective dry eye symptom scores significantly improved with both diquafosol ophthalmic solutions (P ≤ 0.033), although there were no significant differences in BUT compared with placebo. No significant differences between the treatment groups were observed in relation to the occurrence of adverse events. Both 1% and 3% diquafosol ophthalmic solutions are considered effective and safe for the treatment of dry eye syndrome. Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

  6. Comparison of Drug Concentrations in Human Aqueous Humor after the Administration of 0.3% Gatifloxacin Ophthalmic Gel, 0.3% Gatifloxacin and 0.5% Levofloxacin Ophthalmic Solutions

    PubMed Central

    Ding, Wenting; Ni, Weiling; Chen, Huilian; Yuan, Jingqun; Huang, Xiaodan; Zhang, Zheng; Wang, Yao; Yu, Yibo; Yao, Ke

    2015-01-01

    Purpose: To investigate the penetration of 0.3% gatifloxacin ophthalmic gel, 0.3% gatifloxacin ophthalmic solution and 0.5% levofloxacin ophthalmic solution into aqueous humor after topical application. Materials and Methods: Age-related cataract patients (150 eyes in 150 cases) receiving phacoemulsification were randomly divided into three groups: a 0.3% gatifloxacin gel group (n=50), a 0.3% gatifloxacin solution group (n=50), and a 0.5% levofloxacin solution group (n=50). Each group was administered one drop of gel or solution every 15 minutes for four doses. Aqueous samples were collected at different time points after the last drop. High pressure liquid chromatography (HPLC) was applied to determine the concentrations. The one-way ANOVA analysis was performed. Results: Our data indicated that the concentration of the gatifloxacin gel group was higher than that of the gatifloxacin solution group at all time points (P <0.05); moreover, the gatifloxacin gel group exhibited higher levels than the levofloxacin solution group at 120.0 min and 180.0 min (P<0.05). Furthermore, the gatifloxacin gel produced the highest concentration at 120.0 min, and the gatifloxacin and levofloxacin solutions reached their peak values at 60.0 min. Conclusions: 0.3% gatifloxacin ophthalmic gel application produced highest aqueous humor drug concentration, maintained the longest time, had the best penetration and bioavailability. PMID:26078713

  7. 21 CFR 524.1044i - Gentamicin and betamethasone ophthalmic solution.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM... No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Instill one or...

  8. 21 CFR 524.1044i - Gentamicin and betamethasone ophthalmic solution.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM... No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Instill one or...

  9. Azithromycin 1.5% ophthalmic solution: efficacy and treatment modalities in chronic blepharitis.

    PubMed

    Fadlallah, Ali; Rami, Hala El; Fahd, Daoud; Dunia, Ibrahim; Bejjani, Riad; Chlela, Elie; Waked, Naji; Jabbour, Elyse; Fahed, Sharbel

    2012-01-01

    To assess the efficacy of topical 1.5% azithromycin in the treatment of moderate to severe chronic blepharitis and to compare the efficacy of two different treatment modalities. A randomized clinical trial included 67 patients with chronic anterior and/or posterior blepharitis, followed-up for 3 months. Signs and symptoms were graded according to severity. Patients were randomized into two groups: 33 patients in group I and 34 patients in group II. Group I patients were treated with topical 1.5% azithromycin twice a day for three days, and Group II patients were treated with topical 1.5% azithromycin twice a day for three days then at bedtime for the rest of the month. All patients were instructed to apply warm compresses and an eye-friendly soap twice daily. Patients in both groups tolerated the treatment with minimal irritation. A significant improvement in signs and symptoms was noted at the one week follow-up visit. Group II showed a more pronounced and longer-lasting improvement that persisted after three months of follow-up. Topical 1.5% azithromycin ophthalmic solution is an effective treatment option for chronic blepharitis. In moderate to severe blepharitis, a one month treatment is safe and shows better improvement than the three-day protocol with no significant relapse until three months of follow-up.

  10. 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.

  11. 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.

  12. [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.

  13. Safety of prophylactic intracameral moxifloxacin ophthalmic solution after cataract surgery in patients with penetrating keratoplasty

    PubMed Central

    Arslan, Osman Sevki; Arici, Ceyhun; Unal, Mustafa; Cicik, Erdogan; Mangan, Mehmet Serhat; Atalay, Eray

    2014-01-01

    AIM To determine the safety of prophylactic intracameral moxifloxacin after cataract surgery in patients with penetrating keratoplasty (PKP). METHODS In this retrospective study of consecutive patients who had phacoemulsification cataract surgery after PKP, were treated with intracameral moxifloxacin 0.5% ophthalmic solution (0.5 mg/0.1 mL). The main outcome measures were anterior chamber reaction, best corrected visual acuity (BCVA), corneal endothelial cell count (ECC), and central corneal thickness (CCT). RESULTS Fifty-five patients were recruited (26 males, 29 females). The mean age was 54.36±4.97y (range 45-64y). All eyes had improved postoperative BCVA. The mean BCVA was 0.25 preoperatively and 0.57 postoperatively, which was statistically significant (P<0.001). One eye had 3+, 7 eyes had 2+, 12 eyes had 1+ and 8 eyes had trace amount of aqueous cells on the first day after surgery. All eyes had no anterior chamber cells at subsequent follow up examinations. Effective phacoemulsification time was 4.33±1.01s. The mean ECC was 2340.20 cells/mm2 preoperatively and 1948.75 cells/mm2 1mo postoperatively (P<0.001). The increase of 21.09 µm in postoperative pachymetry 1mo after surgery was statistically significant (P<0.001). CONCLUSION No untoward effects were observed after intracameral injection of moxifloxacin (0.5 mg/0.1 mL) in terms of anterior chamber reaction, CCT, ECC, and visual rehabilitation at the conclusion of cataract surgery in patients with PKP. PMID:25349795

  14. The effects of betaxolol hydrochloride ophthalmic solution on intraocular pressures during transient microgravity.

    PubMed

    Pattinson, T J; Gibson, C R; Manuel, F K; Bishop, S L; March, W F

    1999-10-01

    Intraocular pressure (IOP) has been found to increase during microgravity. After peaking in the first few hours of orbital flight, IOP slowly decreases to a level that is slightly elevated above baseline IOP's. These modest elevations in IOP do not require treatment. Just as in 1-G, a clinically significant elevation of IOP that occurred during spaceflight would require treatment. We are not aware of previous studies of the efficacy of IOP lowering agents under conditions of microgravity. This double-masked, placebo-controlled study measured the IOP's of 11 adult subjects (22 eyes) at baseline, preflight, and zero-gravity aboard the NASA KC-135 aircraft, and postflight. One eye of each of the subjects was treated with betaxolol hydrochloride ophthalmic solution 0.5%, while the contralateral eye was treated with normal saline placebo, for 7 d prior to parabolic flight. IOP's were measured by the Tono-Pen 2, a gravity independent tonometer. A modest, but statistically significant reduction of 2.4 mmHg in mean IOP was noted in betaxolol treated eyes at the time of preflight measurement. During zero-G, the mean IOP's of both betaxolol treated eyes and placebo treated eyes increased approximately 20% over preflight levels. Postflight IOP's were similar to preflight IOP's. The effect of betaxolol on the IOP of eyes treated with for 1 wk prior to exposure to microgravity was statistically significant, but may lack clinical significance in normal eyes. Further research needs to be done to determine the efficacy during microgravity of betaxolol and other agents, in subjects who have upper normal to slightly elevated IOP's at 1 G.

  15. Treatment of allergic conjunctivitis with bepotastine besilate ophthalmic solution 1.5%

    PubMed Central

    Bergmann, Mark T; Williams, Jon I; Gomes, Paul J

    2014-01-01

    Purpose To examine the pooled per-protocol ocular end points from two conjunctival allergen challenge (CAC) clinical trials of the dual-action antihistamine bepotastine besilate ophthalmic solution (BBOS) 1.5%. Methods Two Phase III, placebo-controlled, double-masked, randomized clinical trials were conducted at a total of six separate centers using the CAC model of allergic conjunctivitis. The same study design was employed for both clinical trials, with subjects randomly assigned to either BBOS 1.5% (n=78) or placebo (n=79) treatment. Each subject received one eye drop of the test agent bilaterally at different study visits 15 minutes, 8 hours, or 16 hours prior to a CAC. Primary ocular end points included changes in ocular itching reported at 3, 5, and 7 minutes and conjunctival hyperemia assessed at 7, 15, and 20 minutes following each CAC. Secondary ocular end points included chemosis as well as episcleral and ciliary hyperemia judged by investigators, and tearing (scored as either absent or present) and eyelid swelling judged by subjects. Results A statistically significant reduction in ocular itching was observed for BBOS 1.5% treatment compared to placebo at all time points (P<0.0001), while measures for onset and 8-hour persistence of action also reached clinical significance (ie, ≥1.0 unit difference) at a majority of time points. In addition, a significant reduction in conjunctival hyperemia was achieved at a majority of time points during the onset of action CAC test. Secondary end points were also significantly improved compared to placebo, most prominently for reduced tearing at all study visits and reduced eyelid swelling at the onset of action and 8-hour study visits. Adverse events were generally mild and transient. Conclusion BBOS 1.5% rapidly reduced CAC-induced ocular itching with duration of effectiveness of at least 8 hours after dosing. Certain secondary signs of inflammation were also significantly reduced. PMID:25152611

  16. Persistent corneal epithelial defect responding to rebamipide ophthalmic solution in a patient with diabetes

    PubMed Central

    Hayashi, Yusuke; Toshida, Hiroshi; Matsuzaki, Yusuke; Matsui, Asaki; Ohta, Toshihiko

    2016-01-01

    Objective Rebamipide ophthalmic suspension was developed for the treatment of dry eyes and for other corneal diseases, promoting the secretion of both mucin in tear fluid and membrane-associated mucin, increasing the number of goblet cells, and restoring the barrier function of the corneal epithelium. We report a case of a persistent corneal epithelial defect in a patient with diabetes treated with topical application of rebamipide ophthalmic suspension. Case presentation A 73-year-old woman had a history of type 2 diabetes for 35 years and nonproliferative diabetic retinopathy for 23 years. She presented to our department with discharge and ophthalmalgia in the left eye. A corneal ulcer was detected, and culture of corneal scrapings was performed, with Staphylococcus aureus and Streptococcus canis being isolated. The infection was treated with levofloxacin eye drops and ofloxacin ophthalmic ointment based on the sensitivity profile of the isolate. However, a corneal epithelial defect persisted for approximately 2 months despite continuing treatment with 0.1% hyaluronic acid ophthalmic suspension and 0.3% ofloxacin eye ointment. Her hemoglobin A1c was 7.3%. The persistent corneal epithelial defect showed improvement at 2 weeks after treatment with rebamipide unit dose 2% ophthalmic suspension, and it did not recur even when vitrectomy was subsequently performed for vitreous hemorrhage due to progression of diabetic retinopathy. Conclusion This is the first report about efficacy of rebamipide unit dose 2% ophthalmic suspension for presenting persistent corneal epithelial defect in a patient with diabetes. In the present case, the suggested mechanisms are the following: improving the corneal barrier function, stabilization of mucin on the keratoconjunctival epithelium, and improving the wettability and stability of the tear film, which resulted in the promotion of healing of the corneal epithelial defect in a short time period. PMID:27257394

  17. Persistent corneal epithelial defect responding to rebamipide ophthalmic solution in a patient with diabetes.

    PubMed

    Hayashi, Yusuke; Toshida, Hiroshi; Matsuzaki, Yusuke; Matsui, Asaki; Ohta, Toshihiko

    2016-01-01

    Rebamipide ophthalmic suspension was developed for the treatment of dry eyes and for other corneal diseases, promoting the secretion of both mucin in tear fluid and membrane-associated mucin, increasing the number of goblet cells, and restoring the barrier function of the corneal epithelium. We report a case of a persistent corneal epithelial defect in a patient with diabetes treated with topical application of rebamipide ophthalmic suspension. A 73-year-old woman had a history of type 2 diabetes for 35 years and nonproliferative diabetic retinopathy for 23 years. She presented to our department with discharge and ophthalmalgia in the left eye. A corneal ulcer was detected, and culture of corneal scrapings was performed, with Staphylococcus aureus and Streptococcus canis being isolated. The infection was treated with levofloxacin eye drops and ofloxacin ophthalmic ointment based on the sensitivity profile of the isolate. However, a corneal epithelial defect persisted for approximately 2 months despite continuing treatment with 0.1% hyaluronic acid ophthalmic suspension and 0.3% ofloxacin eye ointment. Her hemoglobin A1c was 7.3%. The persistent corneal epithelial defect showed improvement at 2 weeks after treatment with rebamipide unit dose 2% ophthalmic suspension, and it did not recur even when vitrectomy was subsequently performed for vitreous hemorrhage due to progression of diabetic retinopathy. This is the first report about efficacy of rebamipide unit dose 2% ophthalmic suspension for presenting persistent corneal epithelial defect in a patient with diabetes. In the present case, the suggested mechanisms are the following: improving the corneal barrier function, stabilization of mucin on the keratoconjunctival epithelium, and improving the wettability and stability of the tear film, which resulted in the promotion of healing of the corneal epithelial defect in a short time period.

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

    PubMed Central

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

    2017-01-01

    Purpose 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. Patients and methods 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. Results 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. Conclusion VApal ophthalmic solution (500 IU/mL) is safe and effective for the treatment of patients with dry eye. PMID:28694687

  19. 76 FR 81806 - Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Topical Solution

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-29

    ... December 29, 2011. FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for Veterinary Medicine (HFV... for Veterinary Medicine, 21 CFR part 524 is amended as follows: PART 524--OPHTHALMIC AND TOPICAL.... Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. BILLING CODE...

  20. 21 CFR 524.960 - Flumethasone, neomycin sulfate, and polymyxin B sulfate ophthalmic solutions.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS § 524.960 Flumethasone, neomycin sulfate, and polymyxin B sulfate... which microorganisms are not susceptible to the antibiotics incorporated in the drug. (ii) The drug...

  1. Effect of topical ophthalmic dorzolamide(2%)-timolol(0.5%) solution and ointment on intraocular pressure in normal horses.

    PubMed

    Tofflemire, Kyle L; Whitley, Elizabeth M; Flinn, Allison M; Dufour, Valerie L; Ben-Shlomo, Gil; Allbaugh, Rachel A; Griggs, Angela N; Peterson, Chimene S; Whitley, David R

    2015-11-01

    To compare the effect of commercially available solution and compounded ointment formulations of dorzolamide(2%)-timolol(0.5%) on intraocular pressure (IOP) of normal horses. Eighteen clinically normal horses. A randomized, masked prospective design was used with horses divided into two equal groups. One eye of each horse was selected for topical ophthalmic treatment with either 0.2 mL of dorzolamide(2%)-timolol(0.5%) solution or 0.2 g of dorzolamide(2%)-timolol(0.5%) ointment every 12 h for 5 days. The contralateral eye of horses in both groups was untreated. Rebound tonometry was performed every 6 h starting 2 days prior to and ending 2 days after the treatment period. The mean IOP reduction in eyes treated with the solution or ointment formulations was 13%. Untreated eyes in both groups experienced a lesser but still statistically significant reduction in IOP. The IOP values did not return to baseline within 48 h of the last treatment. The commercially available solution and compounded ointment formulations of ophthalmic dorzolamide(2%)-timolol(0.5%) had similar effects on IOP in normal horses. Persistent IOP reduction following cessation of treatment may indicate prolonged drug effect or acclimation of horses to tonometry. © 2014 American College of Veterinary Ophthalmologists.

  2. Effect of treatment with a topical ophthalmic preparation of 1% nalbuphine solution on corneal sensitivity in clinically normal horses.

    PubMed

    Wotman, Kathryn L; Utter, Mary E

    2010-02-01

    To assess the effect of treatment with a topical ophthalmic preparation of 1.2% nalbuphine solution on corneal sensitivity in clinically normal horses. 8 horses. Baseline corneal touch threshold (CTT) was measured (defined as the mean filament length [mm] at which a consistent blink response was elicited) for both eyes of each horse by use of a Cochet-Bonnet aesthesiometer. Subsequently, 0.2 mL of 1.2% nalbuphine solution was instilled in 1 randomly selected eye of each horse, and 0.2 mL of artificial tears solution was instilled in the contralateral eye (control treatment). For all 8 horses, CTT of each eye was measured within 1 minute following nalbuphine or artificial tears administration and every 15 minutes thereafter for 60 minutes. For 5 of the 8 horses, CTT was also measured in both eyes at 120 minutes. Changes in CTT values from baseline over time were assessed, as were differences between treated and control eyes. At any time point, corneal sensitivity following nalbuphine treatment did not differ significantly from control treatment findings. Mean CTTs for nalbuphine-treated and control eyes were 38.8 and 37.9 mm, respectively. In both groups, CTT was significantly lower than baseline value at 15, 45, 60, and 120 minutes. No tearing or redness developed in any eye treated with nalbuphine. Topical administration of ophthalmic 1% nalbuphine solution had no effect on corneal sensitivity in clinically normal horses. The topical ocular treatment was not associated with local irritation.

  3. The safety and efficacy of travoprost 0.004%/timolol 0.5% fixed combination ophthalmic solution.

    PubMed

    Barnebey, Howard S; Orengo-Nania, Silvia; Flowers, Brian E; Samples, John; Mallick, Sushanta; Landry, Theresa A; Bergamini, Michael V W

    2005-07-01

    To compare the safety and intraocular pressure (IOP)-lowering efficacy of travoprost 0.004%/timolol 0.5% fixed combination ophthalmic solution (Trav/Tim) to its components travoprost 0.004% ophthalmic solution, TRAVATAN, (Trav) and timolol 0.5% ophthalmic solution (Tim) in patients with open-angle glaucoma or ocular hypertension. Randomized multicenter, double-masked, active-controlled, parallel group study. Two hundred sixty-three patients with open-angle glaucoma or ocular hypertension were randomized to receive Trav/Tim once daily AM (and vehicle PM), Trav once daily PM (and vehicle AM), or Tim twice daily (AM and PM). Efficacy and safety were compared across treatment groups over 3 months. Trav/Tim produced a mean IOP decrease from baseline of 1.9 mm Hg to 3.3 mm Hg more than Tim, with a significant decrease in mean IOP at each of the nine study visits (P < or = .003). Trav/Tim decreased mean IOP by 0.9 mm Hg to 2.4 mm Hg more than Trav, with a significant decrease in mean IOP at seven of the nine study visits (P < or = .05). The adverse event profile for Trav/Tim was comparable to Trav or Tim alone. Over the 3 months of treatment, Trav/Tim produced clinically relevant IOP reductions in patients with open-angle glaucoma or ocular hypertension that were greater than those produced by either Trav or Tim alone. The clinical results that Trav/Tim was safe and well tolerated with an incidence of adverse events was comparable to the results of Trav or Tim alone. Trav/Tim provides both more effective IOP reduction than its components and the benefits of once-daily dosing.

  4. Comparative study of the ocular efficacy and safety of diclofenac sodium (0.1%) ophthalmic solution with that of ketorolac tromethamine (0.5%) ophthalmic solution in patients with acute seasonal allergic conjunctivitis

    PubMed Central

    Dehar, Navdeep; Gupta, Anita; Singh, Gursatinder

    2012-01-01

    Background: Seasonal allergic conjunctivitis (SAC) is the most common and most prevalent of allergic disorders which afflict the ocular surface. Of the several treatments available, ophthalmic non-steroidal anti-inflammatory drugs, are generally very safe and tolerable. Aim: The aim of this study is to compare the ocular efficacy and safety of diclofenac sodium (0.1%) ophthalmic solution with that of ketorolac tromethamine (0.5%) ophthalmic solution in patients with acute SAC. Materials and Methods: Sixty patients with signs and symptoms of SAC were evaluated in an open, randomized, parallel group study. The principle symptoms (ocular itching, burning, discharge, photophobia) and signs (ocular inflammation, lid edema, chemosis, conjunctival mucous, keratitis) were evaluated. Study Design: Patients were randomized into two groups of 30 each. Patients in group A received one drop of diclofenac sodium 0.1% and patients in group B received ketorolac tromethamine 0.5% in both the eyes four times a day for fourteen days. Evaluations were performed at day 0, 3, 7 and 14 of the therapy. At each visit, the signs and symptoms were rated using a scale from 0-3 (mild-1, moderate-2 and severe-3). Results: Significant clinical and statistical reductions in signs and symptoms from baseline were observed in both groups. Diclofenac sodium 0.1% was superior to ketorolac tromethamine 0.5% in reducing ocular itching (P < 0.05) and ocular inflammation (P < 0.05), at the final examination. Conclusion: Diclofenac sodium showed statistically significant better results at day 3 and 7 compared to ketorolac. PMID:23776804

  5. Effect of benzalkonium chloride-free latanoprost ophthalmic solution on ocular surface in patients with glaucoma

    PubMed Central

    Walimbe, Tejaswini; Chelerkar, Vidya; Bhagat, Purvi; Joshi, Abhijeet; Raut, Atul

    2016-01-01

    Introduction Benzalkonium chloride (BAK), included as a preservative in many topical treatments for glaucoma, induces significant toxicity and alters tear breakup time (TBUT). BAK-containing latanoprost, an ester prodrug of prostaglandin F2α, can cause ocular adverse events (AEs) associated with BAK. The purpose of this study was to evaluate the efficacy and safety of BAK-free latanoprost. Patients and methods A prospective, open-label, single-arm, multicenter, 8-week study in patients with primary open-angle glaucoma or ocular hypertension taking BAK-containing latanoprost for ≥12 months was performed. Patients were switched to BAK-free latanoprost ophthalmic solution 0.005% administered once daily, and eyes were assessed after 28 and 56 days. Primary efficacy and safety variables were TBUT and treatment-emergent AEs, respectively. Results At day 56, 40 eyes were evaluable. Mean TBUT increased significantly from baseline (3.67±1.60 seconds) to 5.03±2.64 and 6.06±3.39 seconds after 28 and 56 days of treatment with BAK-free latanoprost (P<0.0001). Ocular Surface Disease Index© (OSDI©) score also decreased significantly to 12.06±13.40 and 7.06±10.75 at 28 and 56 days, respectively, versus baseline (18.09±18.61, P<0.0001). In addition, inferior corneal staining score decreased significantly to 0.53 from baseline (0.85, P=0.0033). A reduction in conjunctival hyperemia and intraocular pressure was observed at both time points. No treatment-related serious AEs were evident and 12 (26.08%) treatment-emergent AEs occurred in seven patients, with eye pain and irritation being the most frequent. No clinically significant changes in vital signs or slit lamp examinations were observed. Conclusion Results indicate that switching from BAK-containing latanoprost to BAK-free latanoprost resulted in significant improvements in TBUT, OSDI© score, and inferior corneal staining score, and measurable reductions in conjunctival hyperemia score. Furthermore, BAK

  6. High-performance liquid chromatographic determination of benzalkonium and naphazoline or tetrahydrozoline in nasal and ophthalmic solutions.

    PubMed

    Santoni, G; Medica, A; Gratteri, P; Furlanetto, S; Pinzauti, S

    1994-11-01

    A high-performance liquid chromatographic method is described for the determination of benzalkonium chloride homologues and naphazoline nitrate or tetrahydrozoline hydrochloride in ophthalmic and nasal solutions. The technique involves a one-step dilution (1:5) for sample preparation and direct injection onto a 5 mm RP C-8 column. The mobile phase is acetonitrile-diluted acetic acid (80:20, v/v) with 6 mM tetramethylammonium bromide. Detection is carried out at 260 nm with a diode array. The method is rapid, specific, reproducible and is especially useful for quality control procedures.

  7. 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

  8. Stability of fortified cefazolin ophthalmic solutions prepared in artificial tears containing surfactant-based versus oxidant-based preservatives.

    PubMed

    Rojanarata, Theerasak; Tankul, Junlathip; Woranaipinich, Chayanee; Potawanich, Paweena; Plianwong, Samarwadee; Sakulma, Sirinart; Saehuan, Choedchai

    2010-10-01

    The aim of this study was to investigate the stability of fortified cefazolin sodium ophthalmic solutions (50 mg mL⁻¹) extemporaneously prepared in commercial artificial tears containing 2 different types of preservatives, namely the surfactants and oxidants. Fortified cefazolin sodium solutions were prepared by reconstituting cefazolin for injection with sterile water and further diluted with Tears Naturale II or Natear, 2 commercial artificial tears containing polyquaternium-1 and sodium perborate, respectively, as preservatives. The solutions were then kept at room temperature (28°C) or in the refrigerator (4°C). During the 28-day period, the formulations were periodically examined for the physical appearance, pH, and the remaining drug concentrations. The antibacterial potency was evaluated as the minimal inhibitory concentration against Staphylococcus aureus strain ATCC 29923 by broth dilution technique. The activity of the preservatives was demonstrated by antimicrobial effectiveness tests. On day 28, the microbial contamination in the preparations was tested. The stability profiles of cefazolin solutions prepared in Tears Naturale II, Natear, and water were not different, but they were significantly influenced by the storage temperature. The refrigerated formulations showed no loss of drug and antibacterial potency as well as alteration of physical appearance and pH throughout the 28 days. In contrast, those kept at room temperature showed gradual change in color and odor. The degradation of drug exceeded 10% from day 3 and the decrease of antibacterial potency could be observed at week 3. All cefazolin solutions prepared in artificial tears retained the antimicrobial activity of preservatives and were free from bacterial and fungal contamination throughout the 28-day period of study. Cefazolin sodium ophthalmic solutions can be extemporaneously prepared in Tears Naturale II or Natear without the influence from different types of preservatives used in

  9. A randomised, double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients

    PubMed Central

    Takamura, Etsuko; Tsubota, Kazuo; Watanabe, Hitoshi; Ohashi, Yuichi

    2012-01-01

    Aims To compare the efficacy and safety of 3% diquafosol ophthalmic solution with those of 0.1% sodium hyaluronate ophthalmic solution in dry eye patients, using mean changes in fluorescein and rose bengal staining scores as endpoints. Trial design and methods In this multicenter, randomised, double-masked, parallel study of 286 dry eye patients with fluorescein and rose bengal staining scores of ≥3 were randomised to the treatment groups in a 1 : 1 ratio. Efficacy and safety were evaluated after drop-wise instillation of the study drug, six times daily for 4 weeks. Results After 4 weeks, the intergroup difference in the mean change from baseline in fluorescein staining score was −0.03; this verified the non-inferiority of diquafosol. The mean change from baseline in rose bengal staining score was significantly lower in the diquafosol group (p=0.010), thus verifying its superiority. The incidence of adverse events was 26.4% and 18.9% in the diquafosol and sodium hyaluronate groups, respectively, with no significant difference. Conclusions Diquafosol (3%) and sodium hyaluronate (0.1%) exhibit similar efficacy in improving fluorescein staining scores of dry eye patients, whereas, diquafosol exhibits superior efficacy in improving rose bengal staining scores. Diquafosol has high clinical efficacy and is well tolerated with a good safety profile. PMID:22914501

  10. Determination of total polyvinylpyrrolidone (PVP) in ophthalmic solutions by size exclusion chromatography with ultraviolet-visible detection.

    PubMed

    Tavlarakis, Panagiotis; Urban, John J; Snow, Nicholas

    2011-01-01

    A straightforward size exclusion chromatography (SEC) method was developed and validated for the determination of total polivinylpyrrolidone (PVP) in ophthalmic solutions using the unusual combination of size exclusion chromatography (SEC), ultraviolet-visible detection and quantitation of an analyte peak that elutes in the total exclusion volume of the column. Samples of opthalmic solutions are diluted with water and injected onto a TSKgel G1000PW, 7.5 mm i.d. × 30 cm, 12 μm column at 50°C, with 80:20 0.1M sodium acetate-methanol mobile phase and UV detection at 220 nm. Validation was successful for a stability indicating pharmaceutical method, with parameters including specificity, accuracy, linearity, and precision within typical pharmaceutical acceptance criteria. A stress study with acid, base, peroxide, heat, and light indicates that there is no interference from drug, product, or excipients.

  11. 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.

  12. 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

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

    2014-07-01

    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. 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. 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. Bimatoprost/timolol PF demonstrated non-inferiority and equivalence in IOP lowering compared with bimatoprost/timolol, with no significant differences in safety and tolerability. NCT01177098. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  13. 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

  14. 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.

  15. RETRACTED: Azithromycin 1.5% Ophthalmic Solution for Blepharitis Treatment: Comparison of 14- Versus 30-Day Treatment.

    PubMed

    Altay, Yesim; Demirok, Gulizar; Balta, Ozgur; Bolu, Hulya

    2017-06-05

    The online-ahead-of-print published article, "Azithromycin 1.5% Ophthalmic Solution for Blepharitis Treatment: Comparison of 14- Versus 30-Day Treatment," by Altay Yesim, Demirok Gulizar, Balta Ozgur, and Bolu Hulya (DOI: 10.1089/jop.2015.0099) is being officially retracted from Journal of Ocular Pharmacology and Therapeutics (JOPT) due to post-publication authorship disputes and the discovery of simultaneous submission to both JOPT and the International Journal of Ophthalmology, which is a violation of the proper protocols of peer review. Journal of Ocular Pharmacology and Therapeutics and its editorial leadership are committed to maintaining the highest levels of scientific reporting and publishing, and therefore officially retracts the article based on the infringements listed herein.

  16. Simultaneous spectrophotometric-multivariate calibration determination of several components of ophthalmic solutions: phenylephrine, chloramphenicol, antipyrine, methylparaben and thimerosal.

    PubMed

    Collado, M S; Mantovani, V E; Goicoechea, H C; Olivieri, A C

    2000-08-16

    The use of multivariate spectrophotometric calibration for the simultaneous determination of several active components and excipients in ophthalmic solutions is presented. The resolution of five-component mixtures of phenylephrine, chloramphenicol, antipyrine, methylparaben and thimerosal has been accomplished by using partial least-squares (PLS-1) and a variant of the so-called hybrid linear analysis (HLA). Notwithstanding the presence of a large number of components and their high degree of spectral overlap, they have been determined simultaneously with high accuracy and precision, with no interference, rapidly and without resorting to extraction procedures using non aqueous solvents. A simple and fast method for wavelength selection in the calibration step is presented, based on the minimisation of the predicted error sum of squares (PRESS) calculated as a function of a moving spectral window.

  17. 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

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

    PubMed

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

    2013-01-01

    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. 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. 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. 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.

  19. Determination of antazoline and tetrahydrozoline in ophthalmic solutions by capillary electrophoresis and stability-indicating HPLC methods.

    PubMed

    Gumustas, Mehmet; Alshana, Usama; Ertas, Nusret; Goger, Nilgun Gunden; Ozkan, Sibel A; Uslu, Bengi

    2016-05-30

    Capillary electrophoretic (CE) and high performance liquid chromatographic (HPLC) methods were developed and optimized for the determination of antazoline (ANT) and tetrahydrozoline (TET) in ophthalmic formulations. Optimum electrophoretic conditions were achieved using a background electrolyte of 20mM phosphate buffer at pH 7.0, a capillary temperature of 25°C, a separation voltage of 22 kV and a pressure injection of the sample at 50 mbar for 17s. HPLC analysis was performed with Kinetex (150 × 4.6mm ID × 5 μm) (Phenomenex, USA) analytical column with 1 mL min(-1) flow rate of mobile phase which consisted of 0.05% TFA in bidistilled water (pH adjusted to 3.0 with 5M NaOH) and acetonitrile/buffer in the ratio of 63:37 (v/v) at room temperature. Injection volume of the samples was 10 μL and the wavelength of the detector was set at 215 nm for monitoring both analytes. Calibration graphs showed a good linearity with a coefficient of determination (R(2)) of at least 0.998 for both methods. Intraday and interday precision (expressed as RSD%) were lower than 2.8% for CE and 0.92% for HPLC. The developed methods were demonstrated to be simple and rapid for the determination of ANT and TET in ophthalmic solutions providing recoveries in the range between 97.9 and 102.70% for CE and HPLC. Copyright © 2016 Elsevier B.V. All rights reserved.

  20. Evaluation of the frequency of ophthalmic solution application: washout effects of topical saline application on tear components.

    PubMed

    Shigeyasu, Chika; Hirano, Shinichiro; Akune, Yoko; Mochizuki, Hiroshi; Yamada, Masakazu

    2013-07-01

    To determine and compare the effects of single and frequent topical applications of saline solution on tear protein concentration in clinically normal subjects. Tears were collected from both eyes of 11 normal volunteers using Schirmer's strips. Saline solution (0.9% sodium chloride) was applied once in the right eye and five times with an interval of 1 min each in the left eye. Tears were collected before and 5, 15, 30 and 60 min after application of the solution. Total tear protein concentration in the samples was measured by the Bradford method and major tear protein concentration (secretory immunoglobulin A, lactoferrin, lipocalin-1, lysozyme and sialic acid) was measured using a high-performance liquid chromatography assay. A significant decrease was observed in the concentration of total tear protein, major tear proteins and sialic acid after topical application of saline solution. This decrease was attributed to the washout and dilution effect. A low protein concentration persisted longer with more frequent application of the solution. The concentration of secretory immunoglobulin A and sialic acid concentration recovered slowly compared with that of other proteins. Even a single application of saline solution resulted in significant changes in major tear protein and sialic acid concentration in the tears of normal subjects. Differences in the recovery of tear protein concentration may be related to the process of protein production and secretion. A balance between normal tear function and the therapeutic effects of ophthalmic solutions should be considered when deciding the frequency of application, particularly in patients with dry eye.

  1. Azelastine hydrochloride, a dual-acting anti-inflammatory ophthalmic solution, for treatment of allergic conjunctivitis

    PubMed Central

    Williams, Patricia B; Crandall, Elizabeth; Sheppard, John D

    2010-01-01

    Over 50% of patients who seek treatment for allergies present with ocular symptoms. Our current ability to control ocular allergic symptoms is greater than ever before. Newer dual-acting topical eyedrops attack multiple facets of the allergic cascade. Azelastine has antihistaminic effects providing immediate relief, mast cell stabilization providing early-phase intervention, and inhibition of expression and activation of anti-inflammatory mediators which characterize the late phase of the immune reaction. The ophthalmic eyedrop formulation is approved for treatment of allergic conjunctivitis in adults and children aged over 3 years. In clinical trials comparing azelastine with other dual-acting eyedrops, such as levocabastine and olopatadine, azelastine was reported to be slightly less efficacious and to sting briefly upon administration. Even so, many patients experienced the full benefit of symptom relief, and preferred azelastine. As a broad-spectrum drug, azelastine offers many desirable properties for management of ocular allergies. Because it can often produce maximal effect with just twice-daily dosing, azelastine is a particularly good choice for the allergic population in whom minimizing exposure to topical products and preservatives is a key concern. PMID:20856595

  2. 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.

  3. Double-masked, randomized, parallel-group study comparing olopatadine 0.1% ophthalmic solution with cromolyn sodium 2% and levocabastine 0.05% ophthalmic preparations in children with seasonal allergic conjunctivitis

    PubMed Central

    Ciprandi, Giorgio; Turner, Darell; Gross, Robert D.

    2004-01-01

    Background: It is estimated that >50% of medications have not been tested in children. Physicians need pediatric data to guide them in treating children. Olopatadine hydrochloride ophthalmic solution 0.1% is a topical antiallergic agent that is both an antihistamine with high affinity and selectivity for the histamine H1 receptor and a mast cell stabilizer that inhibits the release of histamine and other proinflammatory mediators from human conjunctival mast cells. The efficacy and tolerability of olopatadine has been demonstrated by comparative studies in adults and children with seasonal allergic conjunctivitis (SAC). Objective: Pediatric patient data were extracted from 2 clinical trials to assess the efficacy and tolerability of olopatadine hydrochloride ophthalmic solution 0.1% compared with those of cromolyn sodium ophthalmic solution 2% and levocabastine ophthalmic solution 0.05% as treatment for SAC in children. Methods: In study 1, conducted at 15 centers in 7 countries (Europe and Australia) from October 1995 to December 1997, olopatadine was instilled BID and placebo (vehicle) BID for 6 weeks and compared with cromolyn instilled QID. Study 2, conducted at 17 centers in 8 countries (Europe and Australia) from November 1998 to June 2000, compared olopatadine BID with levocabastine BID. In both studies, children of either sex and any race, aged 4 to 11 years, and having proven grass pollen allergies were assigned to treatment in a double-masked, randomized fashion. Slit-lamp examination, the physician's impression scale, and self-ratings were used to obtain efficacy data. Data analyses were based on pollen concentrations. The tolerability assessments were based on visual acuity, pupil diameter, intraocular pressure, and a dilated fundus examination. Results: Study 1 comprised 30 children (olopatadine [n = 13] and cromolyn sodium [n = 17]; 18 boys, 12 girls; mean age, 7.9 years [range, 4–11 years]). Study 2 comprised 22 children (olopatadine [n = 10] and

  4. Tetrahydrozoline Ophthalmic

    MedlinePlus

    Ophthalmic tetrahydrozoline is used to relieve minor eye irritation and redness caused by colds, pollen, and swimming. ... eye drops.If you still have symptoms of eye irritation after using tetrahydrozoline as directed, call your doctor. ...

  5. Bromfenac Ophthalmic

    MedlinePlus

    ... redness (inflammation) and pain that can occur after cataract surgery. Bromfenac ophthalmic is in a class of ... eye(s) once a day beginning one day before cataract surgery, on the day of the surgery, and ...

  6. Cyclosporine Ophthalmic

    MedlinePlus

    Ophthalmic cyclosporine is used to increase tear production in people with dry eye disease. Cyclosporine is in a class of medications called immunomodulators. It works by decreasing swelling in the eye ...

  7. Ciprofloxacin Ophthalmic

    MedlinePlus

    ... to treat bacterial infections of the eye including conjunctivitis (pinkeye; infection of the membrane that covers the outside ... eye). Ciprofloxacin ophthalmic ointment is used to treat conjunctivitis. Ciprofloxacin is in a class of antibiotics called ...

  8. Bromfenac ophthalmic solution 0.09 %: human aqueous humor concentration detected by high-performance liquid chromatography.

    PubMed

    Macrì, Angelo; Vagge, Aldo; Salis, Annalisa; Fucile, Carmen; Marini, Valeria; Martelli, Antonietta; Giuffrida, Sebastiano; Iester, Michele; Damonte, Gianluca; Mattioli, Francesca

    2017-04-01

    The purpose of this study was to evaluate the aqueous humor concentrations of bromfenac ophthalmic solution 0.09 % in patients undergoing phacoemulsification. Patients requiring cataract extraction received one drop (50 µL) of bromfenac 0.09 % solution in the eye to be operated, before bedtime the day before surgery or the morning of the surgery. The last administration was recorded. At the time of paracentesis, an aqueous humor sample was collected with a 30-gauge needle attached to a TB syringe and was later analyzed by high-performance liquid chromatography for drug concentration. 188 treated volunteers and 48 control, untreated, subjects were included in the study. The mean aqueous concentration of bromfenac in the treated group was 37.60 ± 68.86 and 0 nM (nmol/L) in the control group (p < 0.0001). Correlation coefficient in bromfenac group between time elapsed from instillation and drug concentration was -0.16 (p not significant). Bromfenac showed properties of good penetration and stable concentration in aqueous humor up to about 12 h after instillation.

  9. Lifitegrast ophthalmic solution 5.0% for treatment of dry eye disease: results of the OPUS-1 phase 3 study.

    PubMed

    Sheppard, John D; Torkildsen, Gail L; Lonsdale, John D; D'Ambrosio, Francis A; McLaurin, Eugene B; Eiferman, Richard A; Kennedy, Kathryn S; Semba, Charles P

    2014-02-01

    To assess the efficacy and safety of lifitegrast ophthalmic solution 5.0% compared with placebo in subjects with dry eye disease. Prospective, randomized, double-masked, placebo-controlled, parallel arm, multicenter clinical trial. A total of 588 adult subjects with dry eye disease. Eligible subjects were randomized 1:1 to receive topically administered lifitegrast (5.0%) or placebo (vehicle) twice daily for 84 days after a 14-day open-label placebo run-in period. After enrollment (day 0), subjects were evaluated at days 14, 42, and 84. Key objective (fluorescein and lissamine staining scores [Ora scales]) and subjective (Ocular Surface Disease Index [OSDI], 7-item visual analog scale, and ocular discomfort score [Ora scale]) measures were assessed at all visits. The primary objective efficacy measure (sign) was mean change from baseline inferior corneal staining score (ICSS) at day 84. The co-primary subjective efficacy measure (symptom) was the mean change from baseline in the visual-related function subscale score of the Ocular Surface Disease Index (VR-OSDI). Supportive measures included corneal fluorescein scores (superior, central, total region) and conjunctival lissamine scores (nasal, temporal, total region) and symptom scores at day 84. The study met the primary objective efficacy ICSS end point in demonstrating superiority of lifitegrast compared with placebo (P = 0.0007). Lifitegrast significantly reduced corneal fluorescein staining (superior, P = 0.0392; total cornea, P = 0.0148) and conjunctival lissamine staining (nasal, P = 0.0039; total conjunctiva, P = 0.0086) at day 84 versus placebo. Significant (P < 0.05) improvements in nasal and total lissamine scores were observed at day 14 and maintained through day 84. The study did not meet the co-primary subjective VR-OSDI measure (P = 0.7894). However, significant improvements were observed at day 84 in ocular discomfort (P = 0.0273) and eye dryness (P = 0.0291), the most common and severe symptoms

  10. Conjunctival expression of the P2Y2 receptor and the effects of 3% diquafosol ophthalmic solution in dogs.

    PubMed

    Terakado, Kunihiko; Yogo, Takuya; Kohara, Yukihiro; Soeta, Satoshi; Nezu, Yoshinori; Harada, Yasuji; Hara, Yasushi; Amasaki, Hajime; Tagawa, Masahiro

    2014-10-01

    Conjunctival epithelial and goblet cell P2Y2 nucleotide receptors regulate ion transport and secretory function. Diquafosol is a P2Y2 purinergic receptor agonist that stimulates secretion of aqueous tear components from conjunctival epithelial cells and secretion of mucin from conjunctival goblet cells. In humans suffering from keratoconjunctivitis sicca (dry eye), topical administration of diquafosol improves corneal epithelial integrity and stabilises the tear film. The aim of the present study was to investigate P2Y2 receptor expression and to determine the effect of topical administration of diquafosol on mucin and aqueous tear production in dogs. Canine conjunctival P2Y2 receptor expression was evaluated by Western blotting and immunohistochemical analysis. The effect of diquafosol on mucin secretion was evaluated by examining mucin-5 subtype AC (MUC5AC) concentration in tears. The effect of diquafosol on aqueous secretions was evaluated by performing the Schirmer tear test (STT) and phenol red thread test. Expression of the P2Y2 receptor was confirmed in canine bulbar and palpebral conjunctivae and receptors were identified at the conjunctival epithelial and goblet cell surface. Tear MUC5AC concentration significantly increased after administration of 3% diquafosol ophthalmic solution, although neither STT nor phenol red thread test values showed any significant change after diquafosol instillation. Topical ocular administration of 3% diquafosol might improve corneal epithelial disorders in dogs through stabilisation of the tear film, by virtue of an increase in MUC5AC secretion. Copyright © 2014 Elsevier Ltd. All rights reserved.

  11. Polyvinyl pyrrolidone capped fluorescent anthracene nanoparticles for sensing fluorescein sodium in aqueous solution and analytical application for ophthalmic samples.

    PubMed

    Bhopate, Dhanaji P; Mahajan, Prasad G; Garadkar, Kalyanrao M; Kolekar, Govind B; Patil, Shivajirao R

    2015-11-01

    Based on the known complexation ability between polyvinyl pyrrolidone (PVP) and fluorescein sodium (FL Na(+)), fluorescent PVP capped anthracene nanoparticles (PVP-ANPs) were prepared using a reprecipitation method for detection of fluorescein in aqueous solution using the fluorescence resonance energy transfer (FRET) approach. A dynamic light scattering histogram of PVP-ANPs showed narrower particle size distribution and the average particle size was 15 nm. The aggregation-induced enhanced emission (AIEE) of PVP-ANPs was red shifted from its monomer by 1087.22 cm(-1). The maximum emission was seen to occur at 420 nm. The presence of FL Na(+) in the vicinity of PVP-ANPs quenched the fluorescence of PVP-ANPs because of its adsorption on the surface of PVP-ANPs in aqueous suspension. The FL Na(+) and PVP-ANPs were brought close enough, typically to 7.89 nm, which was less than the distance of 10 nm that is required between the energy donor-acceptor molecule for efficient FRET. The quenching results fit into the Stern-Volmer relationship even at temperatures greater than ambient temperatures. The thermodynamic parameters determined from FRET results helped to propose binding mechanisms involving hydrophobic and electrostatic molecular interaction. The fluorescence quenching results were used further to develop an analytical method for estimation of fluorescein sodium from ophthalmic samples available commercially in the market.

  12. Stability-Indicating HPLC Method for Simultaneous Determination of Chloramphenicol, Dexamethasone Sodium Phosphate and Tetrahydrozoline Hydrochloride in Ophthalmic Solution

    PubMed Central

    AlAani, Hashem; Alnukkary, Yasmin

    2016-01-01

    Purpose: A simple stability-indicating RP-HPLC assay method was developed and validated for quantitative determination of Chloramphenicol, Dexamethasone Sodium Phosphate and Tetrahydrozoline Hydrochloride in ophthalmic solution in the presence of 2-amino-1-(4-nitrophenyl)propane-1,3-diol, a degradation product of Chloramphenicol, and Dexamethasone, a degradation product of Dexamethasone Sodium Phosphate. Methods: Effective chromatographic separation was achieved using C18 column (250 mm, 4.6 mm i.d., 5 μm) with isocratic mobile phase consisting of acetonitrile - phosphate buffer (pH 4.0; 0.05 M) (30:70, v/v) at a flow rate of 1 mL/minute. The column temperature was maintained at 40°C and the detection wavelength was 230 nm. Results: The proposed HPLC procedure was statistically validated according to the ICH guideline, and was proved to be stability-indicating by resolution of the APIs from their forced degradation products. Conclusion: The developed method is suitable for the routine analysis as well as stability studies. PMID:27123429

  13. Safety of Lifitegrast Ophthalmic Solution 5.0% in Patients With Dry Eye Disease: A 1-Year, Multicenter, Randomized, Placebo-Controlled Study.

    PubMed

    Donnenfeld, Eric D; Karpecki, Paul M; Majmudar, Parag A; Nichols, Kelly K; Raychaudhuri, Aparna; Roy, Monica; Semba, Charles P

    2016-06-01

    To evaluate the 1-year safety of lifitegrast ophthalmic solution 5.0% in patients with dry eye disease compared with placebo. SONATA (Safety Of a 5.0% coNcentrATion of lifitegrAst ophthalmic solution) was a multicenter, randomized, prospective, double-masked, placebo-controlled phase 3 study (NCT01636206). Adults (≥18 years) with dry eye disease (Schirmer test score ≥1 and ≤10 mm; corneal staining score ≥2.0) were randomized 2:1 to lifitegrast ophthalmic solution 5.0% or placebo twice daily for 360 days. The primary objective was percentage and severity of treatment-emergent adverse events (TEAEs). Secondary objectives were ocular safety measures: corneal fluorescein staining, drop comfort, best-corrected visual acuity, slit-lamp biomicroscopy, and intraocular pressure over 7 visits. Exploratory objectives included concentration of lifitegrast in plasma. The safety population comprised 331 participants (220 lifitegrast; 111 placebo). There were no serious ocular TEAEs. Overall, 53.6% of participants receiving lifitegrast experienced ≥1 ocular TEAE versus 34.2% in the placebo group; most TEAEs were mild to moderate in severity. Rates of discontinuation because of TEAEs were 12.3% (lifitegrast) versus 9.0% (placebo). The most common (>5%) TEAEs occurring in either treatment group were instillation site irritation (burning), instillation site reaction, visual acuity reduced, dry eye, and dysgeusia (change in taste). Ocular safety parameters for lifitegrast were similar to placebo. The mean plasma lifitegrast concentration at 360 days (n = 43) was below the limit of detection. There was no indication of systemic toxicity or localized infectious complications secondary to chronic immunosuppression. Lifitegrast ophthalmic solution 5.0% seemed safe and well tolerated in this study, with no unexpected adverse events.

  14. Ocular pharmacokinetics comparison between 0.2% olopatadine and 0.77% olopatadine hydrochloride ophthalmic solutions administered to male New Zealand white rabbits.

    PubMed

    Iyer, Ganesh R; Cason, Marita M; Womble, Scott W; Li, Guangming; Chastain, James E

    2015-05-01

    The primary objective of this study was to compare uptake and distribution of the commercially available formulation of 0.2% olopatadine and the newly developed 0.77% olopatadine hydrochloride ophthalmic solution formulation with improved solubility following a single (30 μL), bilateral topical ocular dose in male New Zealand white rabbits. Each animal received a single 30-μL topical ocular dose (0.2% olopatadine or 0.77% olopatadine hydrochloride ophthalmic solution) to the right (OD) eye followed by the left (OS) eye for a total dose of 60 μL. Olopatadine concentrations were measured in ocular tissues (cornea, bulbar, conjunctiva, choroid, iris-ciliary body, whole lens, retina), aqueous humor, and plasma at prespecified time points over 24 h using a qualified liquid chromatography coupled with mass spectrometry (LC-MS/MS) analytical method. Olopatadine was absorbed into the eye and reached maximal levels (Cmax) within 30 min (0.5 h) to 2 h (Tmax) in ocular tissues and plasma for both treatment groups, except for the lens in which the Tmax was 4 h in the 0.2% olopatadine group and 8 h in the 0.77% olopatadine hydrochloride group, respectively. Tissues associated with the site of dosing, that is, the conjunctiva and cornea, had the highest concentrations of olopatadine in both the 0.2% olopatadine (609 and 720 ng/g) and 0.77% olopatadine hydrochloride (3,000 and 2,230 ng/g) dose groups. The greatest differences between 0.2% olopatadine and 0.77% olopatadine hydrochloride were associated with the overall duration and level of ocular exposures. The newly developed 0.77% olopatadine hydrochloride ophthalmic solution formulation resulted in a higher and more prolonged olopatadine concentration in the target tissue, that is, conjunctiva compared to the commercial formulation of 0.2% olopatadine ophthalmic solution.

  15. The Efficacy of 1% Chloramphenicol Eye Ointment Versus 2.5% Povidone-Iodine Ophthalmic Solution in Reducing Bacterial Colony in Newborn Conjunctivae.

    PubMed

    Bramantyo, Triwijayanti; Roeslani, Rosalina Dewi; Andriansjah, Andriansjah; Sitorus, Rita S

    2015-01-01

    This study aimed to evaluate bacterial pattern and reduction of bacterial colonies in neonatal conjunctivae after prophylaxis 1% chloramphenicol eye ointment and 2.5% povidone-iodine ophthalmic solution. A double-blind randomized controlled trial was conducted. Swabs were taken from the inferior fornix conjunctiva of the right eyes of 60 newborns 1 hour after birth. Either the 2.5% povidone-iodine ophthalmic solution or the 1% chloramphenicol eye ointment was randomly applied to the conjunctivae. Conjunctival swabs were taken 2 hours after prophylaxis treatment. Specimens were delivered to the Microbiology Laboratory to determine the number of bacterial colonies and to evaluate bacterial pattern. Sixty eye specimens were included in the study. Bacterial growth was shown in 44 eye specimens, whereas it was not found in the remaining 16 eye specimens. The bacteria found in neonatal conjunctivae was gram-positive coccus (61%), followed by gram-positive bacillus (36%) and gram-negative bacillus (2%). Both agents significantly reduced the bacterial colony-forming unit (P = 0.00); however, the effect was not significantly different as shown by statistics between both groups (P = 0.748), indicating that the 2.5% povidone-iodine ophthalmic solution had a similar effect to the 1% chloramphenicol eye ointment. No adverse effect such as toxic conjunctivitis or corneal haziness was found in both groups. The 2.5% povidone-iodine ophthalmic solution has been proven as effective as the 1% chloramphenicol eye ointment and induces no toxic reaction. Because it is less expensive than the other, it could be recommended as a good alternative for ophthalmia neonatorum prophylaxis. Further studies with a larger sample size should be conducted to confirm its cost-effectiveness.

  16. 21 CFR 524.1044i - Gentamicin and betamethasone ophthalmic solution.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... two drops of solution in the conjunctival sac three or four times a day. (2) Indications for use. For treatment of external bacterial infections of the eye (conjunctiva and cornea). (3) Limitations. Federal law...

  17. 21 CFR 524.1044i - Gentamicin and betamethasone ophthalmic solution.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    .... Each milliliter (mL) of solution contains gentamicin sulfate equivalent to 3 milligrams (mg) of gentamicin base and 1 mg betamethasone acetate equivalent to 0.89 mg betamethasone alcohol. (b) Sponsor....

  18. The effect of povidone-iodine solution applied at the conclusion of ophthalmic surgery.

    PubMed

    Apt, L; Isenberg, S J; Yoshimori, R; Chang, A; Lam, G C; Wachler, B; Neumann, D

    1995-06-01

    Povidone-iodine 5% solution decreases the incidence of postoperative endophthalmitis when used on the eye for preoperative preparation. We sought to determine whether it also minimized conjunctival bacterial flora immediately after surgery by preventing bacteria present on the surface of the eye from entering surgical wounds. In 42 eyes of 40 patients, at the conclusion of surgery, on an alternating basis, each patient received either a drop of a broad-spectrum antibiotic solution (polymyxin B sulfate-neomycin sulfate-gramicidin) or a 5% povidone-iodine solution in the operated-on eye. Bacterial cultures were taken before and after surgery and 24 hours later. The 38 unoperated-on eyes in the unilateral cases served as control eyes. Relative to the control group, povidone-iodine was effective in preventing an increase in the number of colony-forming units (P = .035), while the antibiotic was not. At 24 hours after surgery, the species count was lower in the eyes receiving povidone-iodine than in the antibiotic-treated eyes (P = .034) and was increased in the antibiotic group since the completion of surgery (P = .013), but was lower in the povidone-iodine and antibiotic groups than in the control eyes for both groups (P < .01). Povidone-iodine 5% solution applied to the eye at the conclusion of surgery was more effective at minimizing the number of colony-forming units and species for the first postoperative day than was a broad-spectrum antibiotic. While not true for the antibiotic, the antimicrobial effect of povidone-iodine lasted for at least 24 hours after the completion of surgery.

  19. Concentrations of nandrolone metabolites in urine after the therapeutic administration of an ophthalmic solution.

    PubMed

    Avois, Lidia; Mangin, Patrice; Saugy, Martial

    2007-05-09

    Nandrolone, an anabolic steroid, is used for the treatment of several diseases and is available in various pharmaceutical formulations. The most widely used pharmaceutical formulation is Deca-Durabolin, but other products, such as Keratyl eye drops solution, are also currently administered. Nandrolone is one of the most abused anabolic steroid in sports. Analyses for this anabolic steroid according to the World Anti-Doping Agency (WADA) protocol are based on the identification of the nandrolone two main urinary metabolites which, in humans, are glucuronides of 19-norandrosterone and 19-noretiocholanolone. A positive cut off limit of 2 ng/mL has been set by the anti-doping code for the first metabolite, 19-norandrosterone. In this preliminary study, an eye drops solution (Keratyl) containing a therapeutic dose of a nandrolone sodium sulphate was administered to several male volunteers during 3 days and urines were collected during 3 weeks. Surprisingly, contrary to all expectations, the urinary concentrations measured in urines reached 450 ng/mL and 70 ng/mL for norandrosterone and noretiocholanolone, respectively. Moreover, concentration levels near to 2 ng/mL were found, more than 2 weeks after the last administration, depending on individual metabolism. Inter-variability as well as intra-variability of nandrolone excretion kinetic, regarding this particular administration mode, were also evaluated. Quantification of nandrolone metabolites was performed by GC-MS. The method was previously validated in terms of specificity, precision, linearity, LOD, LOQ, robustness, accuracy and the expanded uncertainty was also evaluated.

  20. Comparison of effect of nepafenac and diclofenac ophthalmic solutions on cornea, tear film, and ocular surface after cataract surgery: the results of a randomized trial

    PubMed Central

    Kawahara, Atsushi; Utsunomiya, Tsugiaki; Kato, Yuji; Takayanagi, Yoshinori

    2016-01-01

    Background The aim of this study was to compare the effects of nepafenac ophthalmic suspension 0.1% (Nevanac) and diclofenac sodium ophthalmic solution 0.1% (Diclod) on the cornea, tear film, and ocular surface after cataract surgery. Methods A total of 60 eyes (60 patients) were selected for this study, with no ocular diseases other than cataract (scheduled for cataract surgery by one surgeon). Patients were randomly enrolled to receive nepafenac or diclofenac in the perioperative period, and cataract surgery was performed using torsional microcoaxial phacoemulsification and aspiration with intraocular lens implantation via a transconjunctival single-plane sclerocorneal incision at the 12 o’clock position. We compared intra- and intergroup differences preoperatively and postoperatively in conjunctival and corneal fluorescein staining scores, tear film breakup times, Schirmer’s tests, the Dry Eye Related Quality of Life Scores, and tear meniscus areas using anterior segment optical coherence tomography. Results The diclofenac group had significantly higher conjunctival and corneal fluorescein staining scores at 4 weeks postoperatively compared with the nepafenac group (P<0.001). Within the diclofenac group, significantly higher conjunctival and corneal fluorescein staining scores were noted at 4 weeks postoperatively than those seen preoperatively (P<0.001) and at 1 week postoperatively (P<0.001). No statistically significant differences were found in any other items. Conclusions Nepafenac ophthalmic suspension 0.1% is considered safe for the corneal epithelium after cataract surgery. PMID:27019091

  1. 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.

  2. Effects of topical ocular application of 1% trifluridine ophthalmic solution in dogs with experimentally induced recurrent ocular canine herpesvirus-1 infection.

    PubMed

    Spertus, Chloe B; Mohammed, Hussni O; Ledbetter, Eric C

    2016-10-01

    OBJECTIVE To determine the effects of topical ocular application of 1% trifluridine ophthalmic solution in dogs with experimentally induced recurrent ocular canine herpesvirus-1 (CHV-1) infection. ANIMALS 10 specific pathogen-free Beagles. PROCEDURES 12 months prior to the beginning of the randomized, masked, placebo-controlled 30-day trial, latent ocular CHV-1 infection was experimentally induced in each dog by topical ocular inoculation of both eyes with a field strain of CHV-1. Recurrent ocular CHV-1 infection was induced by oral administration of prednisolone for 7 days (starting day 1). Starting on the fourth day of prednisolone administration, each dog received 1% trifluridine solution or artificial tears (placebo) topically in both eyes 6 times daily for 2 days and then 4 times daily for 12 days. Ophthalmic examinations were performed every 2 days, and ocular disease scores were calculated. Ocular samples for CHV-1 PCR assays and blood samples for clinicopathologic analyses and assessment of CHV-1 serum neutralization antibody titers were collected at predetermined intervals. RESULTS Conjunctivitis was clinically detected in all dogs by day 4. Compared with dogs receiving placebo, mean and total clinical ocular disease scores were significantly lower and median CHV-1 shedding duration was significantly shorter for the trifluridine-treated dogs. Both groups had increasing CHV-1 serum neutralization antibody titers over time, but no significant differences between groups were detected. Clinicopathologic findings were unremarkable throughout the study. CONCLUSIONS AND CLINICAL RELEVANCE Topical ocular application of 1% trifluridine ophthalmic solution was well tolerated and effective at reducing disease scores and viral shedding duration in dogs with experimentally induced ocular CHV-1 infection, but may require frequent administration.

  3. Safety and efficacy of bromfenac ophthalmic solution (Bromday) dosed once daily for postoperative ocular inflammation and pain.

    PubMed

    Henderson, Bonnie A; Gayton, Johnny L; Chandler, Simon P; Gow, James A; Klier, Sharon M; McNamara, Timothy R

    2011-11-01

    To evaluate the efficacy and ocular safety of bromfenac ophthalmic solution (bromfenac) 0.09% dosed once daily for the treatment of ocular inflammation and pain after cataract surgery with posterior chamber intraocular lens implantation. Randomized, double-masked, vehicle-controlled or active-controlled, multicenter, clinical trials. A total of 872 subjects (872 study eyes: bromfenac in 584, placebo in 288). Four randomized, double-masked, vehicle or active-controlled, clinical trials were conducted at 134 ophthalmology clinics in the United States. Subjects aged ≥ 18 years were randomized to receive either bromfenac 0.09% or placebo dosed once daily beginning 1 day before cataract surgery (day -1), continuing on the day of surgery (day 0), and continuing for an additional postoperative 14 days. Subjects were evaluated for efficacy and safety on days 1, 3, 8, 15, and 22. The primary efficacy end point was cleared ocular inflammation, measured by the summed ocular inflammation score (SOIS; anterior chamber cells and flare) by day 15. The secondary efficacy end point was the number of subjects who were pain-free at day 1. The data from the 4 trials were pooled for analyses. The SOIS and ocular pain. The proportion of subjects who had cleared ocular inflammation by day 15 was significantly higher in the bromfenac 0.09% group than in the placebo group (P < 0.0001). The mean SOIS in the bromfenac 0.09% group was significantly lower than in the placebo group at days 3, 8, 15, and 22 (P < 0.0001). The proportion of subjects who were pain-free at days 1, 3, 8, and 15 was significantly higher in the bromfenac 0.09% group than in the placebo group (P < 0.0001). The incidence of adverse events reported in the bromfenac 0.09% group was significantly lower than in the placebo group (P < 0.0001). On day 15, 84.0% of the bromfenac subjects had ≥ 1-line improvement in visual acuity compared with 66.1% of placebo subjects (P < 0.0001). Bromfenac 0.09% dosed once daily was

  4. Determination of benzalkonium chloride in ophthalmic solutions containing tyloxapol by solid-phase extraction and reversed-phase high-performance liquid chromatography.

    PubMed

    Fan, T Y; Wall, G M

    1993-11-01

    A procedure using solid-phase extraction (Supelcoclean CN) followed by HPLC [Beckman Ultrasphere CN, acetonitrile:phosphate solution (60:40, v/v)] was developed and validated to quantitate the quaternary ammonium preservative benzalkonium chloride in an experimental ophthalmic formulation containing the polymeric material tyloxapol. This procedure makes routine determinations of benzalkonium chloride at concentrations of 0.0035 to 0.01% simpler than the traditional ion-pairing colorimetric methods. This method is quick, specific, and especially useful for drug product stability studies. In addition, because the method distinguishes each homologue, it can be extended to routinely determine the homologue ratio for quality control purposes.

  5. Cytotoxicity of five fluoroquinolone and two nonsteroidal anti-inflammatory benzalkonium chloride-free ophthalmic solutions in four corneoconjunctival cell lines

    PubMed Central

    Ayaki, Masahiko; Iwasawa, Atsuo; Soda, Mitsutaka; Yaguchi, Shigeo; Koide, Ryohei

    2010-01-01

    Purpose: Epithelial disorders after eye surgery can result in visual deterioration and patient discomfort. Such disorders may be caused by drug toxicity. In the present study, we evaluated the toxicity of ophthalmic solutions, with or without benzalkonium chloride (BAK) as the preservative, used for postoperative care. Methods: A range of commercially available antibiotic and anti-inflammatory ophthalmic solutions used postoperatively (ie, levofloxacin, moxifloxacin, gatifloxacin, norfloxacin, tosufloxacin, dibekacin, cefmenoxime, diclofenac, bromfenac, pranoprofen, betamethasone, and fluoromethorone) were assessed in three corneal cell lines and one conjunctival cell line. All antibiotic solutions were BAK free. Cell viability was determined with the 3-(4,5-dimethyl-2 thiazoyl)-2,5-diphenyl-2H-tetrazolium bromide (MTT) assay after cells had been exposed to the drugs for 48 h. The effects of preservatives on cell viability were also determined. Toxicity was compared using the cell viability score (CVS). Results: Based on results of the MTT assay and CVS, the order of cell viability after exposure to the antibiotic solutions was cefmenoxime ≥ tosufloxicin ≥ dibekacin ≥ levofloxacin ≥ norfloxacin = gatifloxacin = moxifloxacin. For the anti-inflammatory solutions, the order of cell viability was betamethasone ≥ betamethasone + fradiomycin > preservative-free diclofenac ≥ preservative-free bromfenac >> 0.02% fluoromethorone ≥ 0.1% fluoromethorone = diclofenac + preservative = bromfenac + preservative = pranoprofen. The anti-inflammatory drugs were more toxic than the antibiotics. The toxicity of antibiotic drugs against ocular surface cells was dependent on the pharmaceutical components of the solution, whereas that of the anti-inflammatory drugs was dependent on both the pharmaceutical components and the preservatives. Conclusion: Postoperative drug-induced epitheliopathy may be caused primarily by anti-inflammatory drugs. CVS is useful in comparing the

  6. Evaluation of alcaftadine 0.25% ophthalmic solution in acute allergic conjunctivitis at 15 minutes and 16 hours after instillation versus placebo and olopatadine 0.1%

    PubMed Central

    Greiner, Jack V; Edwards-Swanson, Kimberly; Ingerman, Avner

    2011-01-01

    Purpose To evaluate the effectiveness of alcaftadine 0.05%, 0.1%, and 0.25% ophthalmic solutions in treating the signs and symptoms of allergic conjunctivitis when compared with olopatadine hydrochloride 0.1% and placebo using the conjunctival allergen challenge (CAC) model. Methods One hundred and seventy subjects were randomized and 164 subjects completed all visits. CAC was performed to determine and confirm subjects’ eligibility at visits 1 and 2, respectively. The CAC was repeated at visit 3 (day 0 ± 3), 16 hours after study medication instillation, and at visit 4 (day 14 ± 3), 15 minutes after instillation. Ocular itching and conjunctival redness were evaluated after an allergen challenge, along with several secondary endpoints. Results Alcaftadine 0.25% and olopatadine 0.1% treatments exhibited significantly lower mean scores compared with placebo for ocular itching and conjunctival redness at visits 3 and 4. Most adverse events were self-limiting and mild in severity. No serious treatment-related adverse events occurred. Conclusion Treatment with alcaftadine 0.25% ophthalmic solution resulted in mean differences of >1 unit (ocular itching) and approximately >1 unit (conjunctival redness), which was significant (P < 0.001) compared with placebo treatment. All doses of alcaftadine were safe and well tolerated in the population studied. PMID:21339800

  7. 364 Zero Itch in Eyes Treated With Olopatadine Hydrochloride Ophthalmic Solution, 0.2% in Bilateral Conjunctival Allergen Challenge Studies

    PubMed Central

    Blaiss, Michael S.; Tort, Maria

    2012-01-01

    Purpose To further assess the prevention of ocular itching with olopatadine hydrochloride ophthalmic solution, 0.2% (OLO) in patients with allergic conjunctivitis. Methods This was a post-hoc analysis of 85 patients participating in 2 prospective, randomized, double-masked bilateral conjunctival allergen challenge (CAC) studies. Patients received OLO in one eye and placebo (vehicle) in the contralateral eye. Ocular itching was self-assessed by patients and rated on a scale of 0 (none) to 4 (severe). To assess onset of action, eligible patients were challenged with antigen 27 minutes after dosing. To assess duration of action, patients were challenged with allergen 16 hours after dosing. The percentage of eyes with zero itching in both studies was assessed at 3 minutes post allergen challenge. Results The percentage of eyes with zero itch at the 3 minutes timepoint after the onset of action allergen challenge was 60.0% for OLO-treated eyes compared with 5.9% for vehicle-treated eyes (P < .0001, OLO vs vehicle). The percentage of eyes with zero itch at 3 minutes post allergen challenge following the 16-hour dosing was 59.8% for OLO-treated eyes compared with 22.0% for vehicle-treated eyes (P < .0001, OLO vs vehicle). Conclusions In bilateral CAC studies, ocular itching was prevented in a higher percentage (P < .0001) of eyes treated with 0.2% olopatadine hydrochloride ophthalmic solution when compared with vehicle as early as 30 minutes and for at least 16 hours post dosing.

  8. Simultaneous determination of active ingredients in an ophthalmic solution by isocratic tandem-mode HPLC connected reverse phase column and strong cation exchange column.

    PubMed

    Marunouchi, Takahiro; Ono, Masaki; Nakajima, Toshiaki; Ito, Yuji; Aketo, Takao

    2006-02-13

    A tandem-mode high performance liquid chromatography (HPLC) system is described here, which employs reversed phase liquid chromatography (RPLC) followed by strong cation exchange liquid chromatography (SCX), was used to determine the mixture of six ingredients in an ophthalmic solution. As a result of investigations, isocratic HPLC methods that using two columns in tandem-mode; Atlantis dC18 (75 mm x 4.6 mm i.d., 3 microm, ODS) and CAPCELL PAK SCX UG80 (75 mm x 4.6 mm i.d., SCX), which have different separation modes, and control of mixture of methanol/ammonium dihydrogenphosphate buffer as used for the eluent, allowed for six target ingredients to be determined simultaneously. And all ingredients separated perfectly and were determined efficiently and rapidly. Validation of the method was accomplished with respect to linearity (r>0.999), recovery (99.4-100.4%), precision (R.S.D. 0.1-0.9%) and specificity. These results suggest that the fusion of different separation modes can be used for the simultaneous determination of ingredients in ophthalmic solutions, and this can be accomplished rapidly and with high precision.

  9. Betaxolol hydrochloride ophthalmic suspension 0.25% and timolol gel-forming solution 0.25% and 0.5% in pediatric glaucoma: a randomized clinical trial.

    PubMed

    Plager, David A; Whitson, Jess T; Netland, Peter A; Vijaya, Lingam; Sathyan, Parthasarathy; Sood, Devindra; Krishnadas, S R; Robin, Alan L; Gross, Robert D; Scheib, Sally A; Scott, Haydn; Dickerson, Jaime E

    2009-08-01

    To describe the safety profile and clinical response on elevated intraocular pressure (IOP) of betaxolol hydrochloride ophthalmic suspension 0.25% (betaxolol) and timolol maleate ophthalmic gel-forming solution (TGFS) (0.25% and 0.5%), in subjects under 6 years of age. Subjects were randomized to betaxolol 0.25% (twice daily) or TGFS (daily) (0.25% or 0.5%) in this double-masked study. IOPs were obtained at the same time of day (9 AM) at 2 baseline visits and weeks 2, 6, and 12. Mean change from baseline in IOP was the primary efficacy parameter. One hundred five subjects were randomized (34 to betaxolol, 35 to TGFS 0.25%, 36 to TGFS 0.5%). Betaxolol, TGFS 0.25%, and TGFS 0.5% produced statistically significant mean reductions in IOP; mean reductions after 12 weeks of treatment were 2.3, 2.9, and 3.7 mm Hg, respectively. In subjects who were not being treated with topical IOP-lowering medication at baseline, mean IOP reductions after 12 weeks of treatment were 3.1, 4.8, and 3.8 mm Hg, respectively. In patients discontinuing 1 or more topical IOP-lowering medications at baseline, mean IOP reductions at Week 12 were 1.8, 1.8, and 3.7 mm Hg, respectively. Responder rates (> or =15% reduction from baseline) for betaxolol, TGFS 0.25%, and TGFS 0.5% were 38.2, 45.7, and 47.2%, respectively. Adverse events were predominantly nonserious and did not interrupt patient continuation in the study. Betaxolol ophthalmic suspension 0.25%, TGFS 0.25%, and TGFS 0.5% were well tolerated. Despite low responder rates, all 3 treatments produced statistically significant mean reductions in IOP in pediatric glaucoma subjects.

  10. [The clinical efficacy of 0.1% bromfenac sodium hydrate ophthalmic solution after excimer laser in situ keratomileusis].

    PubMed

    Xu, Yan; Zhao, Xu; Zhang, Feng-ju; Wang, Meng-meng; Guo, Ning; Zheng, Yan; Liu, Jing; Zhang, Qiu-lu

    2013-04-01

    To investigate the clinical efficacy and safety of 0.1% bromfenac sodium hydrate ophthalmic solution in myopia and astigmatism eyes after sub-Bowman keratomileusis (SBK) METHODS: A case control study. Number of patients with low to moderate myopia (-6.00 D ≤ spherical equivalent < -2.00 D) in the test and control groups was 17 cases (32 eyes) and 20 cases (40 eyes), respectively. Number of patients with high myopia (-11.00 D ≤ spherical equivalent < -6.00 D) in the test and control groups was 22 cases (42 eyes) and 15 cases (26 eyes) respectively. The first day after SBK, 0.1% bromfenac sodium hydrate eye drops was administrated 2 times/day in patients in the test group and continued for 10 and 14 days in low and high myopia, respectively. In the control group, 0.1% fluorometholone eye drops was used 4 times/day, then reduced gradually and continuously for 16 days. Visual acuity, computer refraction, intraocular pressure (IOP) and corneal topography examination were conducted at different postoperative period. Symptoms and related complications were recorded. Ranked data were statistically analyzed using the Wilcoxon rank sum test and quantitative data were analyzed using independent samples t-test. For low to moderate myopic patients, average postoperative IOP and corneal curvature K2 after one and three months in the test group were (7.84 ± 1.35) and (8.13 ± 1.75) mm Hg(1 mm Hg = 0.133 kPa), and (38.66 ± 1.68) and (38.75 ± 1.45) D, respectively; in the control group, these parameters were (9.37 ± 1.28) and (9.47 ± 1.58) mm Hg and (39.56 ± 1.58), and (39.51 ± 1.50) D, respectively. All of these data in the test group were lower than those in the control group, the differences were statistically significant (t = -2.299, -2.112, P < 0.05). There were no significant differences (P < 0.05) in postoperative uncorrected visual acuity, spherical equivalent, corneal curvature K1, astigmatism CY, IOP (after 6 months) and corneal curvature K2 (after 6 months

  11. [Comparison of clinical effects of bromfenac sodium ophthalmic solution 0.1% versus glucocorticoids for post-LASEK usage].

    PubMed

    Chen, Shiyu; Jiang, Yang; Yu, Chenying; Li, Ying

    2015-01-01

    To evaluate the safety, effectiveness and compliance of Bronuck (bromfenac sodium ophthalmic solution 0.1%) following LASEK in comparison with glucocorticoids. In this prospective trial, 60 patients (120 eyes) undergoing LASEK were randomized into the bromfenac sodium group (60 eyes) and control group (60 eyes). Patients in both groups initially received dexamethasone 0.1% four times a day after LASEK for 7 days, and then the patients in the bromfenac sodium group were given Bronuck twice a day for the next 11 weeks, while the patients from the control group were given fluorometholone 0.1% with gradually decreased doses during the same period. Results of the routine examinations done before and 3, 10, 30, 90 and 180 days after LASEK were recorded, including uncorrected visual acuity, best corrected visual acuity, intraocular pressure (IOP), corneal topography, ocular symptoms and signs, which were used for comparison between the two groups. All data of right eyes were analyzed for their independence, normality and homogeneity of variance. Independent samples t-test or non-parametric Mann-Whitney test was performed accordingly. There was no statistically significant difference in IOP and corneal topography (K1, K2, SAI, SRI and CY) between the two groups postoperatively. The IOP was (16.33 ± 6.21) mmHg(1 mmHg = 0.133 kPa), (15.67 ± 2.82) mmHg, (15.35 ± 2.22) mmHg and (13.10 ± 3.41) mmHg in the bromfenac sodium group, and (16.87 ± 3.68) mmHg, (14.05 ± 2.23) mmHg, (14.39 ± 2.22) mmHg and (13.18 ± 2.49) mmHg in the control group at 10, 30, 90 and 180 days, respectively. The bromfenac sodium group showed significantly better uncorrected visual acuity (5.16 ± 0.08) than the control group (5.02 ± 0.09) on day 30 (t = 2.32, P < 0.05). In the bromfenac sodium group, four eyes had visual fatigue, and four eyes had dry eye symptoms on day 180. Epithelial flaps were all well positioned with satisfying healing process. Each group had one case (two eyes) of haze on day

  12. 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

  13. Evaluation of clinical efficacy and safety of tobramycin/dexamethasone ophthalmic suspension 0.3%/0.05% compared to azithromycin ophthalmic solution 1% in the treatment of moderate to severe acute blepharitis/blepharoconjunctivitis.

    PubMed

    Torkildsen, Gail L; Cockrum, Paul; Meier, Edward; Hammonds, William M; Silverstein, Bruce; Silverstein, Steven

    2011-01-01

    To evaluate the clinical efficacy and safety of tobramycin/dexamethasone (TobraDex ST ; 'ST') ophthalmic suspension 0.3%/0.05% compared to azithromycin (Azasite) ophthalmic solution (1%) in the treatment of moderate to severe blepharitis/blepharoconjunctivitis. The study was a multicenter, randomized, investigator-masked, and active-controlled, 15-day study. Enrolled in the study were 122 adult subjects (at least 18 years of age) diagnosed with moderate to severe blepharitis/blepharoconjunctivitis, defined by a minimum score of at least '1' for one of the lid signs, one of the conjunctival signs, and one of the symptoms in at least one eye and a minimum global score (total signs and symptoms score) of '5' in the same eye. One group of 61 subjects received ST with instructions to dose 1  drop four times daily (QID) for 14 days. The other group of 61 subjects received azithromycin and dosed with 1 drop twice daily (BID) for 2 days followed by once daily (QD) dosing for 12 days. Visits were conducted at Day 1 (baseline), Day 8 and Day 15. The a priori primary outcome parameter of the study was the seven-item global score defined as the total score of lid margin redness, bulbar conjunctival redness, palpebral conjunctival redness, ocular discharge (0-3 scale), and lid swelling, itchy eyelids, and gritty eyes (0-4 scale). The study utilized standardized, validated photograph control scales developed by Ora, Inc. (Andover, MA). The study was registered at ClinicalTrials.gov under the registry number NCT01102244. A statistically significant lower mean global score (p = 0.0002) was observed in subjects treated with ST compared to subjects treated with azithromycin at Day 8. No serious adverse events were reported during the course of the study in either group. ST provides a fast and effective treatment of acute blepharitis compared to azithromycin. Initial therapy with the combination of tobramycin/dexamethasone provides faster inflammation relief than azithromycin

  14. Comparison of the analgesic efficacy and safety of nepafenac ophthalmic suspension compared with diclofenac ophthalmic solution for ocular pain and photophobia after excimer laser surgery: a phase II, randomized, double-masked trial.

    PubMed

    Colin, Joseph; Paquette, Bertrand

    2006-04-01

    The aim of this study was to evaluate the efficacy and safety of nepafenac ophthalmic suspension 0.03% and 0.1% for the treatment of postoperative pain and photophobia in patients undergoing excimer photoreactive keratectomy (PRK). In this 7-day, randomized, double-masked, parallel-group trial at 2 sites, patients undergoing PRK surgery were randomly assigned to receive nepafenac ophthalmic suspension 0.03% or 0.1%, or diclofenac sodium ophthalmic solution 0.1%. Patients were treated on day 0 (surgery) and day 1 (the day after surgery). The dose regimen for all 3 treatments was the same. On day 0, patients received 2 drops in the operative eye -1 hour before surgery; 2 drops within 1 hour after surgery; 1 drop -4 hours after the first postoperative dose; and 1 drop -8 hours after the first postoperative dose. On day 1, patients instilled 1 drop of study drug QID. Thereafter, the study medication was discontinued. In the perioperative period, study personnel instilled the drops. The patients instilled the drops when they went home. Patients recorded pain and photophobia from day 0 through day 2, rating pain from 0 to 9 on a visual analog scale (0=none, 9=extreme) and photophobia from 0 to 3 on an ordinal, categoric scale (0=none, 3=severe). Patients were permitted to take acetaminophen 500 mg as needed for pain. They returned for postoperative follow-up visits on days 1, 3, and 7. Adverse events were documented when reported by the patients themselves, and when study personnel asked about specific events. Sixty patients (20 per group) were enrolled. On the day of surgery, there were no significant differences between groups, except at 3 hours after surgery, when the nepafenac 0.03% group had a significantly higher mean pain score than the nepafenac 0.1% group (4.0 vs 3.0; P<0.038). On day 2, the nepafenac 0.1% group had less pain at bedtime than the diclofenac group (mean score, 1.9 vs 3.1; P<0.024) and less photophobia in the morning (mean score, 1.2 vs 1.8; P<0

  15. 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

  16. 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.

  17. Update and critical appraisal of the use of topical azithromycin ophthalmic 1% (AzaSite) solution in the treatment of ocular infections.

    PubMed

    Utine, Canan Asli

    2011-01-01

    Azithromycin is an azalide that acts by binding to the 50S ribosomal subunit of susceptible microorganisms and interfering with microbial protein synthesis. Azithromycin is also noted by anti-inflammatory and immunomodulatory activity. AzaSite(®) (Inspire Pharmaceuticals, Inc, Durham, NC) is azithromycin ophthalmic solution, 1% formulated in polycarbophil (the aqueous mucoadhesive polymer contained in DuraSite(®)) that delivers high and prolonged azithromycin concentrations in a variety of ocular tissues, including the conjunctiva, cornea and particularly the eyelid. AzaSite was approved by the Food and Drug Administration (FDA) in the US in 2007, for the treatment of bacterial conjunctivitis caused by susceptible isolates. This article aims to evaluate the peer-reviewed published scientific literature and to define well-established uses of AzaSite eye drops in the field of ocular infections.

  18. Update and critical appraisal of the use of topical azithromycin ophthalmic 1% (AzaSite®) solution in the treatment of ocular infections

    PubMed Central

    Utine, Canan Asli

    2011-01-01

    Azithromycin is an azalide that acts by binding to the 50S ribosomal subunit of susceptible microorganisms and interfering with microbial protein synthesis. Azithromycin is also noted by anti-inflammatory and immunomodulatory activity. AzaSite® (Inspire Pharmaceuticals, Inc, Durham, NC) is azithromycin ophthalmic solution, 1% formulated in polycarbophil (the aqueous mucoadhesive polymer contained in DuraSite®) that delivers high and prolonged azithromycin concentrations in a variety of ocular tissues, including the conjunctiva, cornea and particularly the eyelid. AzaSite was approved by the Food and Drug Administration (FDA) in the US in 2007, for the treatment of bacterial conjunctivitis caused by susceptible isolates. This article aims to evaluate the peer-reviewed published scientific literature and to define well-established uses of AzaSite eye drops in the field of ocular infections. PMID:21750614

  19. Multicenter open-label study evaluating the efficacy of azithromycin ophthalmic solution 1% on the signs and symptoms of subjects with blepharitis.

    PubMed

    Haque, Reza M; Torkildsen, Gail L; Brubaker, Kurt; Zink, Richard C; Kowalski, Regis P; Mah, Francis S; Pflugfelder, Stephen C

    2010-08-01

    To evaluate the effect of 4 weeks of treatment with azithromycin ophthalmic solution 1% on eyelid bacterial load, tear cytokines, and signs and symptoms of blepharitis. Twenty-six subjects (mean age 64.2 years; 65% female; 100% white) with moderate to severe blepharitis received azithromycin ophthalmic solution 1% in the absence of warm compresses or eyelid scrubs for 28 days (twice a day on days 1 and 2 and once a day on days 3-28). Blepharitis signs and symptoms were evaluated at baseline (day 1) and compared with end of treatment (day 29) and 2 follow-up visits (2 and 4 weeks posttreatment). Tear collection and eyelid margin bacterial cultures were performed at baseline and end of treatment. Tear cytokines were measured by a multiplex immunobead assay. Four-week azithromycin treatment demonstrated significant decreases from baseline in investigator-rated signs of meibomian gland plugging, eyelid margin redness, palpebral conjunctival redness, and ocular discharge (P < or = 0.002) at day 29, which persisted 4 weeks posttreatment (P < or = 0.006). Subject-reported symptoms of eyelid itching, foreign body sensation/sandiness/grittiness, ocular dryness, ocular burning/pain, and swollen/heavy eyelids also demonstrated significant improvement from baseline (P < 0.001 for all symptoms and time points, except P = 0.037 for ocular dryness at visit 4). Eyelid margin culture exhibited significant decreases in coagulase-negative staphylococci and Corynebacterium xerosis bacteria. Changes in tear cytokine concentrations were not observed. Twelve subjects experienced 19 adverse events, 15 of which were ocular and none of which were serious. Azithromycin provided significant improvement in signs and symptoms of blepharitis after 4 weeks of treatment compared with baseline and persisted in the 4-week follow-up period.

  20. Topical ophthalmic NSAIDs: a discussion with focus on nepafenac ophthalmic suspension

    PubMed Central

    Gaynes, Bruce I; Onyekwuluje, Anne

    2008-01-01

    The removal of diclofenac sodium ophthalmic solution as a viable pharmaceutical entity in September 1999 from the US market spurred considerable interest in the general safety and effectiveness of topical ophthalmic NSAIDs for treatment of anterior segment inflammation. In late 1999 the use of topical ocular NSAIDs declined in the US as a result of incidents involving corneal melts and toxicity surrounding use of generic diclofenac. However, since the removal of diclofenac sodium ophthalmic solution from the marketplace, ophthalmic NSAIDs have regained use as viable pharmacotherapeutic entities. Moreover, several new ophthalmic NSAID products have recently been introduced for commercial use in the US including the novel chemical entity nepafenac. The purpose of this report is to revisit the use of topical ophthalmic NSAIDs for the treatment of surgically induced anterior segment inflammation with a particular focus on nepafenac. Nepafenac is unique among ophthalmic NSAIDs in that it is a prodrug deaminated to amfenac, a highly effective non-selective cyclooxygenase inhibitor. In the case of topical ophthalmic NSAIDs, practitioners should carefully weigh the cost-benefit of implementing “highly potent” new drug products because perturbations in pharmacodynamic response due to the inherent novelty in terms of chemical designs may outweigh the demonstrated replicative pharmacologic action of all topical ophthalmic NSAIDs. PMID:19668727

  1. Olopatadine Ophthalmic

    MedlinePlus

    ... and pharmacist if you are allergic to olopatadine, benzalkonium chloride, or any other medications.tell your doctor and ... lenses, you should know that olopatadine solution contains benzalkonium chloride, which can be absorbed by soft contact lenses. ...

  2. Dorzolamide Ophthalmic

    MedlinePlus

    ... solution (liquid) to instill in the eye. Dorzolamide eye drops are usually instilled three times a day. Follow ... any part you do not understand. Use dorzolamide eye drops exactly as directed. Do not use more or ...

  3. Tafluprost Ophthalmic

    MedlinePlus

    ... can lead to gradual loss of vision) and ocular hypertension (a condition which causes increased pressure in ... solution after one use.Tafluprost controls glaucoma and ocular hypertension but does not cure them. Continue to ...

  4. Ophthalmic halo reduced lenses design

    NASA Astrophysics Data System (ADS)

    Limon, Ofer; Zalevsky, Zeev

    2015-05-01

    The halo effect is a very problematic visual artifact occurring in extended depth of focus or multi-focal ophthalmic lenses such as e.g. intra-ocular (after cataract surgery) or contact lenses when used in dark illumination conditions. This artifact is generated due to surface structures added on top of those lenses in order to increase their depth of focus or to realize multiple focal lengths. In this paper we present novel solution that can resolve this major problem of ophthalmic lenses. The proposed solution involves modification to the surface structure that realizes the extended depth of focus. Our solution is fabricated and numerically and experimentally validated also in preliminary in-vivo trials.

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

    PubMed

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

    2013-10-01

    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.

  6. 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

  7. Tear volume estimation using a modified Schirmer test: a randomized, multicenter, double-blind trial comparing 3% diquafosol ophthalmic solution and artificial tears in dry eye patients

    PubMed Central

    Miyake, Hideki; Kawano, Yuri; Tanaka, Hiroshi; Iwata, Akihiro; Imanaka, Takahiro; Nakamura, Masatsugu

    2016-01-01

    Purpose We aimed to evaluate the feasibility of using a modified Schirmer test to determine the increase in tear volume after administration of 3% diquafosol ophthalmic solution (diquafosol 3%) in dry eye patients. Patients and methods A randomized, multicenter, prospective, double-blind clinical study recruited 50 qualified subjects. They received diquafosol 3% in one eye and artificial tears in the other eye. The study protocol comprised a screening and treatment procedure completed within 1 day. The Schirmer test was performed on closed eyes three times a day. The primary efficacy end points were the second Schirmer test scores 10 minutes after the single dose. Secondary end points were the third Schirmer test scores 3 hours and 40 minutes after the single dose and the symptom scores prior to the second and third Schirmer tests. Results According to the Schirmer test, 10 minutes after administration, diquafosol 3% significantly increased tear volume compared to artificial tears. Diquafosol 3% and artificial tears both showed significant improvements in the symptom scores compared to baseline. However, there was no significant difference in the symptoms score between diquafosol 3% and artificial tears. Conclusion The modified Schirmer test can detect a minute change in tear volume in dry eye patients. These findings will be useful in the diagnosis of dry eye, assessment of treatment benefits in daily clinical practice, and the development of possible tear-secreting compounds for dry eye. PMID:27257372

  8. A retrospective review and observational study of outcomes and safety of bimatoprost ophthalmic solution 0.03% for treating eyelash hypotrichosis.

    PubMed

    Yoelin, Steven G; Fagien, Steven; Cox, Sue Ellen; Davis, Paula G; Campo, Antoinette; Caulkins, Carrie A; Gallagher, Conor J

    2014-10-01

    The efficacy and safety of bimatoprost ophthalmic solution 0.03% for treating hypotrichosis were shown in a randomized controlled trial and in an open-label study. To date, no data on real-world experience have been published. To evaluate long-term patient satisfaction, usage patterns, and safety of bimatoprost 0.03% in clinical practice. In this retrospective chart review with a cross-sectional design, adult patients exposed to bimatoprost 0.03% for at least 12 months were randomly sampled from 16 investigational sites. Charts were reviewed for medication usage characteristics and adverse events (AEs). At a study visit, questionnaires eliciting patient-reported outcomes were administered and spontaneously reported AEs were tabulated. Analysis included 585 subjects with a mean (SD) treatment duration of 19.3 (4.3) months. Patient satisfaction with bimatoprost 0.03% was 92.5%; on average, approximately 3 applications per week maintained benefits. Overall, 27.4% of patients spontaneously recalled experiencing AEs while on treatment; however, patient charts showed that only 4 AEs were documented. No instances of iris hyperpigmentation occurred. No serious or severe AEs were noted. Treatment with bimatoprost 0.03% for at least 12 months is safe, and long-term use is associated with a high degree of satisfaction.

  9. Long-term safety evaluation of bimatoprost ophthalmic solution 0.03%: a pooled analysis of six double-masked, randomized, active-controlled clinical trials

    PubMed Central

    Wirta, David; VanDenburgh, Amanda M; Weng, Emily; Whitcup, Scott M; Kurstjens, Sef; Beddingfield, Frederick C

    2011-01-01

    Background: Bimatoprost ophthalmic solution 0.03% was approved in the US for reducing intraoccular pressure (IOP) based on two double-masked, active-controlled clinical trials. Four additional long-term studies (≥12 months) were conducted; however, the aggregate safety profile of the six studies has not been reported. Methods: Adverse events (AEs) were pooled from six double-masked, active-controlled, long-term clinical trials in which subjects received bimatoprost 0.03% once daily (QD) or twice daily (BID) as an eyedrop. AE terms were converted to MedDRA (V.11.0) Preferred Terms and analyzed. Results: In total, 1409 patients received more than one dose of bimatoprost 0.03% QD or BID. Most AEs were mild in severity and reported by 86.7% (QD) and 94.8% (BID) of subjects (≤12 months of treatment). AEs reported through month 12 (aggregate incidence of ≥5%) were conjunctival hyperemia, increased eyelash growth, eye pruritus, periocular skin hyperpigmentation, eye irritation, dry eye, and hypertrichosis. AE onset was generally reported within four months of treatment. The cumulative incidence of common AEs in the QD treatment group at 24–48 months was similar to that measured at 12 months of treatment. Conclusion: Bimatoprost 0.03% has a favorable safety and tolerability profile as characterized by six long-term studies. Common AEs were due to the known pharmacological activity of bimatoprost and reversible with treatment cessation. PMID:21691584

  10. Effectiveness of ophthalmic solution preservatives: a comparison of latanoprost with 0.02% benzalkonium chloride and travoprost with the sofZia preservative system

    PubMed Central

    2011-01-01

    Background Although in vitro and in vivo laboratory studies have suggested that benzalkonium chloride (BAK) in topical ophthalmic solutions may be detrimental to corneal epithelial cells, multiple short- and long-term clinical studies have provided evidence supporting the safety of BAK. Despite the conflicting evidence, BAK is the most commonly used preservative in ophthalmic products largely due to its proven antimicrobial efficacy. This study was designed to characterize the antimicrobial performance of two commonly used topical ocular hypotensive agents that employ different preservative systems: latanoprost 0.005% with 0.02% BAK and travoprost 0.004% with sofZia, a proprietary ionic buffer system. Methods Each product was tested for antimicrobial effectiveness by European Pharmacopoeia A (EP-A) standards, the most stringent standards of the three major compendia, which specify two early sampling time points (6 and 24 hours) not required by the United States Pharmacopeia or Japanese Pharmacopoeia. Aliquots were inoculated with between 105 and 106 colony-forming units of the test organisms: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans and Aspergillus brasiliensis. Sampling and enumeration were conducted at protocol-defined time points through 28 days. Results BAK-containing latanoprost met EP-A criteria by immediately reducing all bacterial challenge organisms to the test sensitivity and fungal challenges within the first six hours while the preservative activity of travoprost with sofZia did not. Complete bacterial reduction by travoprost with sofZia was not shown until seven days into the test, and fungal reduction never exceeded the requisite 2 logs during the 28-day test. Travoprost with sofZia also did not meet EP-B criteria due to its limited effectiveness against Staphylococcus aureus. Both products satisfied United States and Japanese pharmacopoeial criteria. Conclusions Latanoprost with 0.02% BAK exhibited more

  11. Effects of 3% diquafosol sodium ophthalmic solution on higher-order aberrations in patients diagnosed with dry eye after cataract surgery

    PubMed Central

    Inoue, Yasushi; Ochi, Shintarou

    2017-01-01

    Purpose To evaluate the effects of diquafosol sodium ophthalmic solution 3% (DQS) and artificial tears (AT) on higher-order aberrations (HOAs) in patients with dry eye after cataract surgery. Design This was a post hoc analysis of a previously conducted randomized clinical study. Methods Fifty-nine eyes from 42 patients (17 males and 25 females, aged 72.6±8.0 years) with verified or suspected dry eye at 4 weeks after cataract surgery were evaluated. The dry eye patients were randomly assigned to receive DQS or AT for 4 weeks. Tear breakup time (BUT), corneal and conjunctival fluorescein staining scores, and HOAs were analyzed before and after instillation. HOAs were measured consecutively for 10 seconds with a wavefront analyzer. Average HOAs, HOA fluctuations (fluctuation index [FI]) and changes in HOAs (stability index [SI]) were compared within and between the two groups. Results After 4 weeks of instillation, BUT significantly increased (P=0.001) compared with preinstillation values in the DQS group, but not in the AT group. This increase in BUT in the DQS group was significantly greater than in the AT group (P=0.014). Corneal and conjunctival fluorescein staining scores after instillation significantly improved compared with preinstillation values in the DQS group (P=0.018). In HOAs, the cornea aberration changed from an upward curve (a sawtooth pattern) to an almost constant value (a stable pattern) in the DQS group, but not in the AT group. In FI and SI, there were no significant changes in either group; however, FI and SI were significantly lower in the DQS group than in the AT group (both, P=0.004). Conclusion The dry eye patients after cataract surgery had a visual dysfunction in HOAs. DQS is effective to treat dry eye disease after cataract surgery with improvement of visual function. PMID:28096651

  12. Ocular pharmacokinetics of bimatoprost formulated in DuraSite compared to bimatoprost 0.03% ophthalmic solution in pigmented rabbit eyes

    PubMed Central

    Shafiee, Afshin; Bowman, Lyle M; Hou, Eddie; Hosseini, Kamran

    2013-01-01

    Purpose To compare the aqueous humor (AH) and iris-ciliary body (ICB) concentration of bimatoprost in rabbit eyes treated with ISV-215 (0.03% bimatoprost formulated in DuraSite) with the marketed product bimatoprost 0.03% ophthalmic solution. Methods The left eye of rabbits received a single topical instillation of either ISV-215 (n = 32 eyes) or bimatoprost 0.03% (n = 32 eyes). At predetermined time points, levels of bimatoprost and bimatoprost acid in the AH and the ICB were quantified by HPLC-MS/MS. Results Both bimatoprost and bimatoprost acid were detected in the AH and the ICB within 15 minutes of dosing. Bimatoprost acid concentrations in both compartments were markedly higher than bimatoprost. There was a statistically significant (P < 0.01) increase in the concentration of the prodrug in the AH and its acid form in the ICB in animals treated with ISV-215 compared to bimatoprost 0.03%. In the ISV-215-treated rabbit eyes, the highest concentrations of bimatoprost and bimatoprost acid were in the ICB and AH, respectively, while in the bimatoprost 0.03%-treated eyes, no differences in the drug content of the selected ocular tissues were observed. Conclusions Bimatoprost 0.03% formulated in DuraSite has superior ocular distribution and area under the curve compared to bimatoprost 0.03% in rabbit eyes. This improvement in the pharmacokinetic parameters of ISV-215 may provide us with a better platform to optimize a bimatoprost formulation that offers the same degree of efficacy in lowering intraocular pressure and improved therapeutic index in glaucomatous patients by lessening the ocular side effects associated with long-term use of topical prostaglandin F2α analogs. PMID:23940414

  13. Validated spectrofluorimetric and spectrophotometric methods for the determination of brimonidine tartrate in ophthalmic solutions via derivatization with NBD-Cl. Application to stability study.

    PubMed

    Ibrahim, F; El-Enany, N; El-Shaheny, R N; Mikhail, I E

    2015-05-01

    Two simple, selective and accurate methods were developed and validated for the determination of brimonidine tartrate (BT) in pure state and pharmaceutical formulations. Both methods are based on the coupling of the drug with 4-chloro-7-nitro-2,1,3-benzoxadiazole in borate buffer (pH 8.5) at 70 °C and measurement of the reaction product spectrophotometrically at 407 nm (method I) or spectrofluorimetrically at 528 nm upon excitation at 460 nm (method II). The calibration graphs were rectilinear over the concentration ranges of 1.0-16.0 and 0.1-4.0 µg/mL with lower detection limits of 0.21 and 0.03, and lower quantification limits of 0.65 and 0.09 µg/mL for methods I and II, respectively. Both methods were successfully applied to the analysis of commercial ophthalmic solution with mean recovery of 99.50 ± 1.00 and 100.13 ± 0.71%, respectively. Statistical analysis of the results obtained by the proposed methods revealed good agreement with those obtained using a comparison method. The proposed spectrofluorimetric method was extended to a stability study of BT under different ICH-outlined conditions such as alkaline, acidic, oxidative and photolytic degradation. Furthermore, the kinetics of oxidative degradation of the drug was investigated and the apparent first-order reaction rate constants, half-life times and Arrhenius equation were estimated. The proposed methods are practical and valuable for routine applications in quality control laboratories for the analysis of BT.

  14. Clinical efficacy of olopatadine hydrochloride ophthalmic solution 0.2% compared with placebo in patients with allergic conjunctivitis or rhinoconjunctivitis: a randomized, double-masked environmental study.

    PubMed

    Abelson, Mark B; Gomes, Paul J; Vogelson, Cullen T; Pasquine, Terri A; Gross, Robert D; Turner, F Darell; Wells, David T; Bergamini, Michael V W; Robertson, Stella M

    2004-08-01

    Previous studies have suggested that olopatadine hydrochloride ophthalmic solution 0.2% administered once daily is effective for up to 24 hours after instillation and is well tolerated in adults and children aged > or =3 years. The goal of this study was to evaluate the efficacy and safety profile of olopatadine 0.2% compared with placebo in patients with seasonal allergic conjunctivitis or rhinoconjunctivitis. This was a 10-week, randomized, placebo-controlled, double-masked environmental study conducted during the spring allergy season (April-August) of 2003. Patients assessed their ocular signs and symptoms in terms of frequency (whole-unit scale from 0 to 5) and severity (half-unit scale from 0 to 4), and grass pollen counts were obtained daily for each investigative site. Responder analyses were conducted by pollen level (frequency based) and pollen period (severity based) to evaluate the clinical significance of differences in ocular itching and redness between treatment groups. Two hundred sixty patients (137 females, 123 males) were enrolled in the study, including 28 children aged between 11 and 17 years; the overall population was 74% white, 11% black, 4% Hispanic, and 11% other. The frequency-based responder analyses of ocular itching and redness showed that when grass pollen counts were high (>20 gr/m(3) air), a respective 21% and 14% of patients in the olopatadine 0.2% group assessed the frequency of ocular itching and redness as >2, compared with 47% and 31% of patients in the placebo group (P < 0.001 for ocular itching; P < 0.003 for redness). The results of the severity-based responder analyses by peak pollen period were consistent with those of the frequency-based analyses. Compared with placebo, olopatadine 0.2% was associated with significant reductions in calculated mean scores for ocular itching and redness by pollen level and by pollen period. No patient was discontinued from the study because of a treatment-related adverse event, and no

  15. Neomycin, Polymyxin, and Bacitracin Ophthalmic

    MedlinePlus

    Neo-polycin® Ophthalmic Ointment (as a combination product containing Bacitracin, Neomycin, Polymyxin B) ... to explain any part you do not understand. Use neomycin, polymyxin, and bacitracin ophthalmic ointment exactly as ...

  16. 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.

  17. Aberrations of sphero-cylindrical ophthalmic lenses.

    PubMed

    Malacara, Z; Malacara, D

    1990-04-01

    The authors have presented in two previous articles the graphic solutions resembling Tscherning ellipses, for spherical as well as for aspherical ophthalmic lenses free of astigmatism or power error. These solutions were exact, inasmuch as they were based on exact ray tracing, and not third-order theory as frequently done. In this paper sphero-cylindrical lenses are now analyzed, also using exact ray tracing. The functional dependence of the astigmatism and the power error for these lenses is described extensively.

  18. Allergy to ophthalmic preservatives.

    PubMed

    Hong, Jison; Bielory, Leonard

    2009-10-01

    The purpose of the present review is to examine the hypersensitivity reactions to preservatives in topical ophthalmic therapies. Ocular hypersensitivity reactions to different types of preservatives in different chemical classes of topical ophthalmic treatments reviewed in the literature include IgE-mast cell mediated, cell mediated and toxic. Quaternary ammoniums (benzalkonium chloride) are most commonly (8% reported cases in OVID and PubMED based searches) associated with irritant toxic reactions whereas the organomercurials (thimerosal) and the alcohols (chlorobutanol) have the highest association (19% of OVID and 14% of PubMED based searches and 20% of OVID and 11% of PubMED searches), respectively, with allergic responses although the term allergy for the 'alcohols' appears to be actually an irritant effect whereas the organomercurials appear to truly interact with the immune system as neoantigens. A large number of clinical and experimental studies reveal that preservatives in topical ophthalmic medications have been demonstrated to produce effects from inflammation/ hypersensitivity to permanent cytotoxic effects involving all structures of the eye.

  19. Metabolic Acidosis with Ophthalmic Dorzolamide in a Neonate

    PubMed Central

    Capino, Amanda C.; Dannaway, Douglas C.

    2016-01-01

    Carbonic anhydrase inhibitors are a common cause of normal anion gap metabolic acidosis; however, development is less commonly associated with ophthalmic administration of these agents. We report a case of a premature neonate who was being treated at our institution with betaxolol, dorzolamide, and latanoprost ophthalmic products for suspected bilateral congenital glaucoma. In addition, the patient was also receiving caffeine, ursodiol, and acidified liquid human milk fortifier. The patient developed a normal anion gap metabolic acidosis, and both dorzolamide ophthalmic solution and the acidified human milk fortifier were considered potential causes. Upon discontinuation of the dorzolamide ophthalmic solution and the switching of liquid human milk fortifiers, the normal anion gap metabolic acidosis gradually resolved. As a result of the pH and acidity, the acidified liquid human milk fortifier is thought to be associated with an anion gap acidosis; therefore, dorzolamide is suspected to be the primary cause of a normal gap acidosis. This case demonstrates that systemic effects can occur with ophthalmic administration of dorzolamide in a premature neonate. Ophthalmic agents should not be overlooked as a potential cause of systemic toxicity. PMID:27453705

  20. Rosacea - the ophthalmic perspective.

    PubMed

    Awais, Muhammad; Anwar, Muhammad Irfan; Iftikhar, Raheel; Iqbal, Zohaib; Shehzad, Nazia; Akbar, Bushra

    2015-01-01

    Rosacea is a chronic cutaneous inflammatory disorder with variable presentations. Although primarily considered a skin disease, rosacea may involve the eyes in a significant number of patients leading to ocular complications. It has been recognized that many patients of ocular rosacea in dermatological outpatient department (OPD) go unnoticed as the physicians don't ask about eye symptoms. Same holds true in ophthalmic OPD's where the doctors usually don't consider this diagnosis. The diagnosis of ocular rosacea primarily relies on observation of ophthalmic clinical features but it can be easily missed if accompanying cutaneous features are subtle or inconsistent. The subject diagnosis if not diagnosed and treated promptly, may cause varying degrees of ocular morbidity and may impair vision secondary to corneal involvement. To review published literature and provide an overview on different pathophysiologic mechanisms of ocular rosacea and clinical features required for its diagnosis. As well as to highlight various treatment modalities available for ocular rosacea. In our study Medline and Google Scholar were the key search engines to find literature using keywords like epidemiology, pathogenesis, clinical features, management and complications of ocular rosacea.

  1. 21 CFR 886.1140 - Ophthalmic chair.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 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...

  2. 21 CFR 886.1140 - Ophthalmic chair.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 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...

  3. 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...

  4. 21 CFR 886.1140 - Ophthalmic chair.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 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...

  5. 21 CFR 886.1140 - Ophthalmic chair.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 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...

  6. 21 CFR 886.4790 - Ophthalmic sponge.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 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,...

  7. 21 CFR 886.4790 - Ophthalmic sponge.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 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,...

  8. 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,...

  9. 21 CFR 886.4790 - Ophthalmic sponge.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 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,...

  10. 21 CFR 886.4790 - Ophthalmic sponge.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 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,...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. Assessment of the tolerability profile of an ophthalmic solution of 5% glycyrrhizin and copolymer PEG/PPG on healthy volunteers and evaluation of its efficacy in the treatment of moderate to severe blepharitis

    PubMed Central

    Mencucci, Rita; Favuzza, Eleonora; Menchini, Ugo

    2013-01-01

    Purpose To evaluate the tolerability on healthy volunteers and the efficacy on subjects affected by chronic moderate/severe blepharitis of a 5% glycyrrhizin and copolymer poly(ethylene glycol)/poly(propylene glycol)(PEG/PPG) ophthalmic solution. Methods The study was a randomized, controlled, open label, intra-patient monocentric study. It consisted of two different phases, the assessment of tolerability phase on 20 healthy volunteers, and the evaluation of the efficacy on 21 subjects affected by chronic moderate/severe blepharitis; the treatment period was 2 weeks, followed by 1-week of follow-up. In the efficacy phase, in both eyes, eyelid hygiene was also performed. At day 0, 3, 7, 14, and 21 a complete ophthalmological examination was performed. In the tolerability phase, signs of clinical toxicity were recorded and subject-reported symptoms were collected using a questionnaire. In the efficacy phase, global signs and symptoms of blepharitis scores were collected using standardized photographic scales and questionnaire. The statistical analysis was performed using the Wilcoxon signed-rank test. Results No ocular signs of drug toxicity were reported. During the treatment period for tolerability phase, there were statistically significant higher scores of tearing and ocular discomfort in the tolerability study group versus the tolerability control group. In the efficacy phase, differences between global scores of the two groups were statistically significant at day 0 (score of the efficacy study group was higher than the efficacy control group; P = 0.005) and at day 21 (score of the efficacy study group was lower than the efficacy control group (P ≤ 0.001).The difference of global scores at day 3, 7, 14, and 21 versus day 0 was statistically significant in both groups. No serious adverse events occurred. Conclusion The 5% glycyrrhizin ophthalmic solution was well tolerated in healthy volunteers and in patients with chronic moderate/severe blepharitis, and in

  17. Ophthalmic manifestations postlightning strike.

    PubMed

    Dhillon, Permesh Singh; Gupta, Mohit

    2015-03-31

    Various ophthalmic complications affecting the anterior and posterior segments have been identified due to lightning strike. We report the first case of an indirect lightning-induced full thickness macular hole formation in the UK as evidenced by slit lamp examination and optical coherence tomography (OCT) scan in a 77-year-old woman presenting with sudden visual loss in her right eye and thermal skin injury affecting her scalp. Her best corrected visual acuities were LogMAR 0.46 and 0.12 in the right and left eyes, respectively. There were no other ocular manifestations observed in either eye. She was initially managed conservatively with non-steroidal anti-inflammatory drug eye drops but surgery was later advised due to minimal changes in the visual acuity and macular hole on follow-up. OCT scanning is important in diagnosing macular holes, which usually warrant surgical intervention. 2015 BMJ Publishing Group Ltd.

  18. Ophthalmic manifestations postlightning strike

    PubMed Central

    Dhillon, Permesh Singh; Gupta, Mohit

    2015-01-01

    Various ophthalmic complications affecting the anterior and posterior segments have been identified due to lightning strike. We report the first case of an indirect lightning-induced full thickness macular hole formation in the UK as evidenced by slit lamp examination and optical coherence tomography (OCT) scan in a 77-year-old woman presenting with sudden visual loss in her right eye and thermal skin injury affecting her scalp. Her best corrected visual acuities were LogMAR 0.46 and 0.12 in the right and left eyes, respectively. There were no other ocular manifestations observed in either eye. She was initially managed conservatively with non-steroidal anti-inflammatory drug eye drops but surgery was later advised due to minimal changes in the visual acuity and macular hole on follow-up. OCT scanning is important in diagnosing macular holes, which usually warrant surgical intervention. PMID:25827914

  19. Efficacy of olopatadine HCI 0.1%, ketotifen fumarate 0.025%, epinastine HCI 0.05%, emedastine 0.05% and fluorometholone acetate 0.1% ophthalmic solutions for seasonal allergic conjunctivitis: a placebo-controlled environmental trial.

    PubMed

    Borazan, Mehmet; Karalezli, Aylin; Akova, Yonca Aydin; Akman, Ahmet; Kiyici, Halil; Erbek, Selim S

    2009-08-01

    We aimed to compare the clinical efficacy and ocular surface variables of olopatadine, ketotifen fumarate, epinastine, emedastine and fluorometholone acetate ophthalmic solutions in preventing the signs and symptoms of seasonal allergic conjunctivitis (SAC). This was a prospective, randomized, double-blinded and placebo-controlled study. A total of 100 patients with SAC were randomly assigned to one of five groups, in which they were administered olopatadine, ketotifen fumarate, epinastine, emedastine or fluorometholone acetate, instilled twice daily for 2 weeks. One eye of each patient was treated with the study drug and the other was treated with a placebo. Signs and symptoms of allergic conjunctivitis (itching, redness, tearing, chemosis and eyelid swelling) were scored on a 4-point scale. Each symptom was assessed at baseline and then again after 1 and 2 weeks of treatment. Ocular surface variables were assessed by conjunctival impression cytology. At weeks 1 and 2, all antiallergic agents were significantly more effective than placebo in alleviating itching, redness, tearing, chemosis and eyelid swelling. Fluorometholone acetate was significantly less effective than the other agents in reducing itching and redness at all control visits. Ocular surface findings by impression cytology improved significantly after all treatments compared with placebo. In patients with SAC, olopatadine, ketotifen, epinastine and emedastine are more efficacious than fluorometholone acetate in preventing itching and redness. All the antiallergic agents gave similar results in terms of reducing tearing, chemosis and eyelid swelling. Our data showed that impression cytology parameters improved after treatment with antiallergic agents in patients with SAC.

  20. Polymyxin B and Trimethoprim Ophthalmic

    MedlinePlus

    Polymyxin B and trimethoprim ophthalmic combination is used to treat bacterial infections of the eye including conjunctivitis (pinkeye; infection ... inside and outer parts of the eyelid). Polymyxin B and trimethoprim are in a class of medications ...

  1. Ophthalmic Disparities in Transgender Patients.

    PubMed

    Hollar, Matthew W; Zhang, Matthew M; Mawn, Louise A

    2016-01-01

    Transgender individuals experience unique challenges with regards to discrimination and access to health care. Further, their unique health-care needs and challenges lead to greater rates of morbidity. This article seeks to review the unique biology of transgender patients and the effects of cross-sex hormone therapy on ophthalmic and non-ophthalmic pathology. Attention is given to topics in neuro-ophthalmology, oculoplastics, and retinal disease.

  2. Effects of travoprost 0.004% ophthalmic solution, six weeks after its laminated packaging had been removed, in primary open-angle glaucoma: a randomized, controlled, investigator-blinded study.

    PubMed

    Reis, Ricardo; dos Santos, Lucia Cristina; Vila, Marcos P; Magacho, Leopoldo

    2004-12-01

    Primary open-angle glaucoma (POAG) is a chronic and progressive optic nerve and retinal nerve fiber layer neuropathy, with characteristic visual field damage. The intraocular pressure (IOP) is typically higher than the level considered statistically normal. Although there is no known cure, appropriate reduction of IOP with hypotensive drugs (eg, the topical prostaglandin analogue travoprost) delays the progression of POAG. Chemical-stability studies of travoprost performed by the manufacturer suggest that the stability of travoprost is maintained beyond the expiration date, which is 6 weeks after the laminated packaging has been opened. The goal of this study was to assess the efficacy and tolerability of travoprost 0.004% ophthalmic solution, 6 to 12 weeks after its expiration date, in patients with POAG. This randomized, controlled, investigator-blinded study was conducted at 2 centers in Brazil: the Ophthalmology Department, Federal University of Goiás, Goiânia, and the Ophthalmology Department, Santa Casa de Misericordia Hospital in São José do Rio Preto, Sao Paulo. Patients with POAG (in 1 or both eyes) were randomly assigned to receive travoprost, either from a bottle from which the laminated packaging had been removed and that had been stored at room light and temperature for 6 weeks (ie, after the expiration date; opened group), or from a bottle that had been sealed until first use by the patient (control group). Drug was to be administered, 1 drop in the lower conjunctival sac (in the affected eye[s]), QD between 7 pm and 9 pm, for 6 weeks. IOP was measured at study weeks 0 (baseline), 4, and 6. The 2 treatment groups were compared with regard to hypotensor effect and incidence of adverse events (AEs). : Thirty-one patients completed the study (55 eyes; 28 right and 27 left eyes; 35 eyes of women, 20 eyes of men). The mean (SD) ages of the opened and control groups were 61.8 (13.5) and 62.8 (14.1) years, respectively. Twenty-four patients were included

  3. Evaluation of comfort using olopatadine hydrochloride 0.1% ophthalmic solution in the treatment of allergic conjunctivitis in contact lens wearers compared to placebo using the conjunctival allergen-challenge model.

    PubMed

    Brodsky, Miguel; Berger, William E; Butrus, Salim; Epstein, Arthur B; Irkec, Murat

    2003-04-01

    Olopatadine hydrochloride 0.1% ophthalmic solution is a topical antiallergy agent indicated for treatment of the signs and symptoms of allergic conjunctivitis. The purpose of this study was to evaluate the comfort of olopatadine used for contact lens wearers in the conjunctival allergen-challenge (CAC) model. This was a single-center, randomized, double-masked, parallel-controlled CAC study. Contact lens-wearing subjects with a history of allergic conjunctivitis were randomized to receive olopatadine or placebo bilaterally. Fifteen minutes after study medication instillation, subjects inserted contact lenses. Allergen challenge was performed 10 minutes after contact lens insertion. Subjective evaluations of ocular comfort were obtained immediately and every minute after CAC, up to and including 10 minutes. Thereafter, comfort evaluations were made every 5 minutes up to and including 60 minutes. Subjects evaluated itching at 3, 7, and 10 minutes and redness was graded at 5, 10, and 20 minutes. All evaluations were graded on standardized scales. Subjects were given diaries in which to rate comfort at 2, 4, 6, 9, 12, and 13 hours and the time of contact lens removal. At post-study medication instillation, post-lens insertion, and at time points from 1 to 10 minutes post-allergen challenge, ocular comfort evaluations were statistically superior in subjects receiving olopatadine as compared with those receiving placebo (P < 0.05). The difference in time until contact lens removal was clinically significant, with subjects who were treated with olopatadine wearing lenses for an average of 2.1 hours longer than placebo group. As evidenced by significantly greater comfort and longer duration of lens wear, olopatadine provides superior comfort to contact lens wearers suffering from the signs and symptoms of seasonal allergic conjunctivitis, as induced by the CAC model.

  4. Potential bias in ophthalmic pharmaceutical clinical trials

    PubMed Central

    Varner, Paul

    2008-01-01

    To make clinicians aware of potential sources of error in ophthalmic pharmaceutical clinical trials that can lead to erroneous interpretation of results, a critical review of the study design of various pharmaceutical ophthalmic clinical trials was completed. Discrepancies as a result of study shortcomings may explain observed differences between reported ophthalmic trial data and observed clinical results. PMID:19668731

  5. 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

  6. 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

  7. Phase 3 Randomized Double-Masked Study of Efficacy and Safety of Once-Daily 0.77% Olopatadine Hydrochloride Ophthalmic Solution in Subjects With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge Model.

    PubMed

    McLaurin, Eugene; Narvekar, Abhijit; Gomes, Paul; Adewale, Adeniyi; Torkildsen, Gail

    2015-10-01

    To assess the efficacy and safety of a novel once-daily 0.77% olopatadine hydrochloride ophthalmic solution in subjects with allergic conjunctivitis (AC) using the conjunctival allergen challenge (CAC) model. In this 5-week, multicenter, double-masked, phase 3, randomized trial, subjects aged ≥18 years with a history of AC and a confirmed positive bilateral CAC response were randomized 2:2:2:1 to receive olopatadine 0.77%, olopatadine 0.2%, olopatadine 0.1%, or vehicle, respectively, following a single topical dose in each eye. The primary objective was superiority of olopatadine 0.77% over all comparators on ocular itching according to a 0 to 4 scale (0 = none and 4 = incapacitating itch) at 24-hour duration of action and over vehicle only at the onset of action (3, 5, and 7 minutes after CAC for both). In total, 345 subjects were randomized. Olopatadine 0.77% was superior to the vehicle at alleviating ocular itching at all post-CAC time points at the onset of action and at 24 hours (difference in means: -0.9 to -1.5; P < 0.0001). Superiority in relieving ocular itching was also demonstrated for olopatadine 0.77% versus olopatadine 0.2% and 0.1% at 24 hours (difference in means: -0.3 to -0.5; P < 0.05). Additionally, olopatadine 0.77% significantly improved conjunctival redness and total redness compared with all comparators at the onset of action (differences in means: -0.3 to -0.6 and -0.8 to -2.0, respectively; both P < 0.05). No safety concerns for olopatadine 0.77% were identified. Olopatadine 0.77% demonstrated a rapid onset and prolonged duration of action. It was superior to all comparators in alleviating AC-associated ocular itching with a favorable safety profile.Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01743027.

  8. 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.

  9. 21 CFR 886.4855 - Ophthalmic instrument table.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic instrument table. 886.4855 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4855 Ophthalmic instrument table. (a) Identification. An ophthalmic instrument table is an AC-powered or manual device on which ophthalmic...

  10. 21 CFR 886.4230 - Ophthalmic knife test drum.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 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...

  11. 21 CFR 886.4230 - Ophthalmic knife test drum.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 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...

  12. 21 CFR 886.4230 - Ophthalmic knife test drum.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 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...

  13. 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...

  14. 21 CFR 886.4230 - Ophthalmic knife test drum.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 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...

  15. Human Microbiota and Ophthalmic Disease.

    PubMed

    Lu, Louise J; Liu, Ji

    2016-09-01

    The human ocular surface, consisting of the cornea and conjunctiva, is colonized by an expansive, diverse microbial community. Molecular-based methods, such as 16S rRNA sequencing, has allowed for more comprehensive and precise identification of the species composition of the ocular surface microbiota compared to traditional culture-based methods. Evidence suggests that the normal microbiota plays a protective immunological role in preventing the proliferation of pathogenic species and thus, alterations in the homeostatic microbiome may be linked to ophthalmic pathologies. Further investigation of the ocular surface microbiome, as well as the microbiome of other areas of the body such as the oral mucosa and gut, and their role in the pathophysiology of diseases is a significant, emerging field of research, and may someday enable the development of novel probiotic approaches for the treatment and prevention of ophthalmic diseases.

  16. Human Microbiota and Ophthalmic Disease

    PubMed Central

    Lu, Louise J.; Liu, Ji

    2016-01-01

    The human ocular surface, consisting of the cornea and conjunctiva, is colonized by an expansive, diverse microbial community. Molecular-based methods, such as 16S rRNA sequencing, has allowed for more comprehensive and precise identification of the species composition of the ocular surface microbiota compared to traditional culture-based methods. Evidence suggests that the normal microbiota plays a protective immunological role in preventing the proliferation of pathogenic species and thus, alterations in the homeostatic microbiome may be linked to ophthalmic pathologies. Further investigation of the ocular surface microbiome, as well as the microbiome of other areas of the body such as the oral mucosa and gut, and their role in the pathophysiology of diseases is a significant, emerging field of research, and may someday enable the development of novel probiotic approaches for the treatment and prevention of ophthalmic diseases. PMID:27698616

  17. Pulmonary complications from ophthalmic preparations.

    PubMed

    Prakash, U B; Rosenow, E C

    1990-04-01

    Topical beta-adrenergic blocking agents are commonly used to treat glaucoma. Exacerbations of asthma and bronchospasm caused by topical beta-adrenergic ophthalmic preparations are well known. We describe a 67-year-old woman who had aspiration pneumonitis characterized by a nodular infiltrate in the right middle lobe of the lung and nocturnal coughing after beginning topical application of an ointment (Lacri-Lube) for treatment of xerophthalmia. Bronchial washing demonstrated lipid-laden pulmonary alveolar macrophages. After the use of Lacri-Lube was discontinued, her cough and the chest roentgenographic abnormality totally disappeared. We postulate that the topical ophthalmic preparation, which contains mineral oil and petrolatum, drained into the nasopharynx, trachea, and bronchial tree through the nasolacrimal duct and caused lipoid pneumonitis from aspiration of the oil contents. To our knowledge, this is the first report of pulmonary complications caused by Lacri-Lube. We briefly review the pulmonary complications, including pulmonary edema, apnea from paralysis of respiratory muscles, bronchospasm from non-beta-adrenergic blocking drugs, and electrolyte abnormalities, attributable to topically and systemically administered ophthalmic medications.

  18. Appearance concerns in ophthalmic patients

    PubMed Central

    James, H; Jenkinson, E; Harrad, R; Ezra, D G; Newman, S

    2011-01-01

    Aims This study aimed to determine the psychosocial and appearance-related concerns of a sample of ophthalmic patients by measuring a range of psychological, social, and demographic factors. Methods Standardized psychological measures including anxiety, depression, appearance-related distress, self-discrepancy, appearance salience and valence were administered to 98 participants attending ophthalmic outpatient clinics in either London, Bristol, Sheffield or Bradford. Differences between groups were explored using t-tests and ANOVA, relationships between all variables were investigated using Pearson's correlation coefficient. Results Although mean scores for psychological adjustment were within the normal range, some participants were experiencing considerable levels of generalized anxiety. Being older, male, and married or living with a partner was related to significantly better adjustment. Better adjustment was also related to a less visible area of concern, greater disguisability of the affected area, a more positive evaluation of their own appearance, less engagement in comparing themselves with others, greater feelings of being accepted by others, appearance being less important to their self-concept, and a smaller discrepancy between the persons ideal and actual appearance. Conclusions A majority of ophthalmic patients adjust positively to the demands placed on them. By identifying the variables that are associated with successful adaptation, the specific psychological interventions and appropriate systems of support can be put in place to help those who are adversely affected. PMID:21597486

  19. Fine needle aspiration biopsy of ophthalmic tumors☆

    PubMed Central

    Singh, Arun D.; Biscotti, Charles V.

    2012-01-01

    A majority of intraocular tumors can be diagnosed based on clinical examination and ocular imaging studies, which obviate the need for diagnostic ophthalmic fine needle aspiration biopsy (FNAB). Overall, diagnostic accuracy of ophthalmic FNAB is high but limited cellularity can compromise the diagnostic potential of ophthalmic aspirate samples. The role of ophthalmic FNAB is limited in retinal tumors. Orbital FNAB should be considered in the evaluation of lacrimal gland tumors, orbital metastasis, and lymphoproliferative lesions. Negative cytologic diagnosis of malignancy should not be considered unequivocal proof that an intraocular malignancy does not exist. With improved understanding of genetic prognostic factors of uveal melanoma, ophthalmic FNAB is gaining popularity for prognostic purposes in combination with eye conserving treatment of the primary tumor. In special clinical indications, ancillary studies such as immunohistochemistry and FISH can be performed on ophthalmic FNAB samples. Assistance of an experienced cytopathologist cannot be overemphasized. PMID:23960981

  20. Stimuli sensitive hydrogels for ophthalmic drug delivery: A review

    PubMed Central

    Kushwaha, Swatantra KS; Saxena, Prachi; Rai, AK

    2012-01-01

    Amongst the various routes of drug delivery, the field of ocular drug delivery is one of the most interesting and challenging endeavors facing the pharmaceutical scientist for past 10-20 years. As an isolated organ, eye is very difficult to study from a drug delivery point of view. Despite this limitation, improvements have been made with the objective of maintaining the drug in the biophase for an extended period. A major problem in ocular therapeutics is the attainment of an optimal drug concentration at the site of action. To achieve effective ophthalmic therapy, an adequate amount of active ingredient must be delivered and maintained within the eye. The most frequently used dosage forms, i.e., eye solution, eye ointments, eye gels, and eye suspensions are compromised in their effectiveness by several limitations leading to poor ocular bioavailability. Ophthalmic use of viscosity-enhancing agents, penetration enhancers, cyclodextrins, prodrug approaches, and ocular inserts, and the ready existing drug carrier systems along with their application to ophthalmic drug delivery are common to improve ocular bioavailability. Amongst these hydrogel (stimuli sensitive) systems are important, which undergo reversible volume and/or sol-gel phase transitions in response to physiological (temperature, pH and present of ions in organism fluids, enzyme substrate) or other external (electric current, light) stimuli. They help to increase in precorneal residence time of drug to a sufficient extent that an ocularly delivered drug can exhibit its maximum biological action. The concept of this innovative ophthalmic delivery approach is to decrease the systemic side effects and to create a more pronounced effect with lower doses of the drug. The present article describes the advantages and use stimuli sensitive of hydrogel systems in ophthalmic drug delivery. PMID:23119233

  1. Stimuli sensitive hydrogels for ophthalmic drug delivery: A review.

    PubMed

    Kushwaha, Swatantra Ks; Saxena, Prachi; Rai, Ak

    2012-04-01

    Amongst the various routes of drug delivery, the field of ocular drug delivery is one of the most interesting and challenging endeavors facing the pharmaceutical scientist for past 10-20 years. As an isolated organ, eye is very difficult to study from a drug delivery point of view. Despite this limitation, improvements have been made with the objective of maintaining the drug in the biophase for an extended period. A major problem in ocular therapeutics is the attainment of an optimal drug concentration at the site of action. To achieve effective ophthalmic therapy, an adequate amount of active ingredient must be delivered and maintained within the eye. The most frequently used dosage forms, i.e., eye solution, eye ointments, eye gels, and eye suspensions are compromised in their effectiveness by several limitations leading to poor ocular bioavailability. Ophthalmic use of viscosity-enhancing agents, penetration enhancers, cyclodextrins, prodrug approaches, and ocular inserts, and the ready existing drug carrier systems along with their application to ophthalmic drug delivery are common to improve ocular bioavailability. Amongst these hydrogel (stimuli sensitive) systems are important, which undergo reversible volume and/or sol-gel phase transitions in response to physiological (temperature, pH and present of ions in organism fluids, enzyme substrate) or other external (electric current, light) stimuli. They help to increase in precorneal residence time of drug to a sufficient extent that an ocularly delivered drug can exhibit its maximum biological action. The concept of this innovative ophthalmic delivery approach is to decrease the systemic side effects and to create a more pronounced effect with lower doses of the drug. The present article describes the advantages and use stimuli sensitive of hydrogel systems in ophthalmic drug delivery.

  2. 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.

  3. Stability of latanoprost in an ophthalmic lipid emulsion using polyvinyl alcohol.

    PubMed

    Sakai, Yusuke; Yasueda, Shin-Ichi; Ohtori, Akira

    2005-11-23

    Latanoprost in water is not stable against heat stress due to hydrolysis of the isopropyl ester in the latanoprost molecule. Therefore, the storage condition of latanoprost ophthalmic solution, Xalatan brand, was in a low temperature (2-8 degrees C). We formulated a favorable ophthalmic lipid emulsion of latanoprost using polyvinyl alcohol as emulsifier which showed a good heat stability. The assays of the latanoprost ophthalmic lipid emulsions adjusted to pH 5.0, 6.0 and 7.0 were 100.4%, 100.7% and 99.2% after storage for 4 weeks at 60 degrees C, respectively. The possibility of room temperature storage for the latanoprost ophthalmic lipid emulsion was demonstrated.

  4. Comparison of ophthalmic beta-blocking agents.

    PubMed

    Lesar, T S

    1987-06-01

    Glaucoma is described, and the chemistry, pharmacology, pharmacokinetics, clinical efficacy, adverse effects, and dosage and administration of betaxolol and levobunolol in comparison with timolol are reviewed. Betaxolol and levobunolol are two beta-adrenergic blocking agents being marketed as ophthalmic solutions for treatment of primary open-angle glaucoma (POAG) and ocular hypertension (OHT). Betaxolol is a relatively cardioselective beta-adrenergic blocker, while levobunolol is a nonselective beta-adrenergic blocking agent. Double-blind comparative trials have suggested that betaxolol has an equal to slightly lower efficacy and levobunolol has equal efficacy in reducing intraocular pressure (IOP) compared with timolol, the first ophthalmic beta blocker. A mean reduction in intraocular pressure of 15-35% occurs with both betaxolol and levobunolol and is reported to be maintained with prolonged use. Betaxolol is associated with a higher (25%) incidence of local ocular adverse reactions than timolol. However, betaxolol produces less systemic beta 2- and possibly beta 1-adrenergic receptor blockade than either timolol or levobunolol. Betaxolol may be relatively safer to use in patients with reactive airway disease than either timolol or levobunolol. Levobunolol causes a similar to greater incidence of local ocular adverse reactions and similar systemic beta blockade compared with timolol. Levobunolol may possibly be longer acting than timolol, allowing more patients to be controlled by once-daily dosing. Betaxolol and levobunolol appear to be similar to timolol in controlling IOP in patients with POAG and OHT; additional experience with these agents is needed to assess the advantages and disadvantages of each agent.

  5. Mini drug pump for ophthalmic use.

    PubMed

    Saati, Saloomeh; Lo, Ronalee; Li, Po-Ying; Meng, Ellis; Varma, Rohit; Humayun, Mark S

    2010-03-01

    To evaluate the feasibility of developing a novel mini drug pump for ophthalmic use. Using principles of microelectromechanical systems engineering, a mini drug pump was fabricated. The pumping mechanism is based on electrolysis and the pump includes a drug refill port as well as a check valve to control drug delivery. Drug pumps were tested first on the bench-top and then after implantation in rabbits. For the latter, we implanted 4 elliptical (9.9 x 7.7 x 1.8 mm) non-electrically active pumps into 4 rabbits. The procedure is similar to implantation of a glaucoma aqueous drainage device. To determine the ability to refill and also the patency of the cannula, at intervals of 4-6 weeks after implantation, we accessed the drug reservoir with a transconjunctival needle and delivered approximately as low as 1 microL of trypan blue solution (0.06%) into the anterior chamber. Animals were followed by slit lamp examination, photography, and fluorescein angiography. Bench-top testing showed 2.0 microL/min delivery when using 0.4 mW of power for electrolysis. One-way valves showed reliable opening pressures of 470 mmHg. All implanted devices refilled at 4-6 weeks intervals for 4-6 months. No infection was seen. No devices extruded. No filtering bleb formed over the implant. A prototype ocular mini drug pump was built, implanted, and refilled. Such a platform needs more testing to determine the long term biocompatibility of an electrically-controlled implanted pump. Testing with various pharmacological agents is needed to determine its ultimate potential for ophthalmic use.

  6. Mini drug pump for ophthalmic use.

    PubMed

    Saati, Saloomeh; Lo, Ronalee; Li, Po-Ying; Meng, Ellis; Varma, Rohit; Humayun, Mark S

    2009-12-01

    To evaluate the feasibility of developing a novel mini drug pump for ophthalmic use. Using principles of microelectromechanical systems engineering, a mini drug pump was fabricated. The pumping mechanism is based on electrolysis, and the pump includes a drug refill port as well as a check valve to control drug delivery. Drug pumps were tested first on the benchtop and then after implantation in rabbits. For the latter, we implanted 4 elliptical (9.9 x 7.7 x 1.8 mm) non-electrically active pumps into 4 rabbits. The procedure is similar to implantation of a glaucoma seton. To determine the ability to refill and also the patency of the cannula, at intervals of 4 to 6 weeks after implantation, we accessed the drug reservoir with a transconjunctival needle and delivered approximately as low as 1 microL of trypan blue solution (0.06%) into the anterior chamber. Animals were followed up by slit-lamp examination, photography, and fluorescein angiography. Benchtop testing showed 2.0 microL/min delivery when using 0.4 mW of power for electrolysis. One-way valves showed reliable opening pressures of 470 mm Hg. All implanted devices refilled at 4- to 6-week intervals for 4 to 6 months. No infection was seen. No devices extruded. No filtering bleb formed over the implant. A prototype ocular mini drug pump was built, implanted, and refilled. Such a platform needs more testing to determine the long-term biocompatibility of an electrically controlled implanted pump. Testing with various pharmacologic agents is needed to determine its ultimate potential for ophthalmic use.

  7. 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.

  8. Ophthalmic applications of femtosecond lasers

    NASA Astrophysics Data System (ADS)

    Kurtz, Ron M.; Spooner, Greg J. R.; Sletten, Karin R.; Yen, Kimberly G.; Sayegh, Samir I.; Loesel, Frieder H.; Horvath, Christopher; Liu, HsiaoHua; Elner, Victor; Cabrera, Delia; Muenier, Marie-Helene; Sacks, Zachary S.; Juhasz, Tibor; Miller, Doug L.; Williams, A. R.

    1999-06-01

    We investigated three potential femtosecond laser ophthalmic procedures: intrastromal refractive surgery, transcleral photodisruptive glaucoma surgery and photodisruptive ultrasonic lens surgery. A highly reliable, all-solid-state system was used to investigate tissue effects and demonstrate clinical practicality. Compared with longer duration pulses, femtosecond laser-tissue interactions are characterized by smaller and more deterministic photodisruptive energy thresholds, smaller shock wave and cavitation bubble sizes. Scanning a 5 (mu) spot below the target tissue surface produced contiguous tissue effects. Various scanning patterns were used to evaluate the efficacy, safety, and stability of three intrastromal refractive procedures in animal eyes: corneal flap cutting, keratomileusis, and intrastromal vision correction (IVC). Superior dissection and surface quality results were obtained for the lamellar procedures. IVC in rabbits revealed consistent, stable pachymetric changes, without significant inflammation or corneal transparency degradation. Transcleral photodisruption was evaluated as a noninvasive method for creating partial thickness scleral channels to reduce elevated intraocular pressure associated with glaucoma. Photodisruption at the internal scleral surface was demonstrated by focusing through tissue in vitro without collateral damage. Femtosecond photodisruptions nucleated ultrasonically driven cavitation to demonstrate non-invasive destruction of in vitro lens tissue. We conclude that femtosecond lasers may enable practical novel ophthalmic procedures, offering advantages over current techniques.

  9. 21 CFR 886.1410 - Ophthalmic trial lens clip.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 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,...

  10. 21 CFR 886.1420 - Ophthalmic lens gauge.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 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...

  11. 21 CFR 886.1420 - Ophthalmic lens gauge.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 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...

  12. 21 CFR 886.1420 - Ophthalmic lens gauge.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 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...

  13. 21 CFR 886.1410 - Ophthalmic trial lens clip.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 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,...

  14. 21 CFR 886.1410 - Ophthalmic trial lens clip.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 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,...

  15. 21 CFR 886.1420 - Ophthalmic lens gauge.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 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...

  16. Ophthalmic statistics note 5: diagnostic tests—sensitivity and specificity.

    PubMed

    Saunders, Luke J; Zhu, Haogang; Bunce, Catey; Doré, Caroline J; Freemantle, Nick; Crabb, David P

    2015-09-01

    This is the fifth statistics note produced by the Ophthalmic Statistics Group (OSG) which is designed to be a simple guide to ophthalmic researchers on a statistical issue with an applied ophthalmic example. The OSG is a collaborative group of statisticians who have come together with a desire to raise the statistical standards of ophthalmic researcher by increasing statistical awareness of common issues.

  17. 21 CFR 886.4750 - Ophthalmic eye shield.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 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...

  18. 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...

  19. 21 CFR 886.4750 - Ophthalmic eye shield.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 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...

  20. 21 CFR 886.4750 - Ophthalmic eye shield.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 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...

  1. 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...

  2. 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...

  3. 21 CFR 886.1650 - Ophthalmic bar prism.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ophthalmic bar prism. 886.1650 Section 886.1650...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1650 Ophthalmic bar prism. (a) Identification. An ophthalmic bar prism is a device that is a bar composed of fused prisms of gradually increasing...

  4. 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...

  5. 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...

  6. 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...

  7. 21 CFR 886.1665 - Ophthalmic rotary prism.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic rotary prism. 886.1665 Section 886.1665...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1665 Ophthalmic rotary prism. (a) Identification. An ophthalmic rotary prism is a device with various prismatic powers intended to be handheld and...

  8. 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...

  9. 21 CFR 886.1665 - Ophthalmic rotary prism.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic rotary prism. 886.1665 Section 886.1665...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1665 Ophthalmic rotary prism. (a) Identification. An ophthalmic rotary prism is a device with various prismatic powers intended to be handheld and...

  10. 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...) 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...

  11. 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...

  12. 21 CFR 886.1665 - Ophthalmic rotary prism.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic rotary prism. 886.1665 Section 886.1665...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1665 Ophthalmic rotary prism. (a) Identification. An ophthalmic rotary prism is a device with various prismatic powers intended to be handheld and...

  13. 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...

  14. 21 CFR 886.1650 - Ophthalmic bar prism.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic bar prism. 886.1650 Section 886.1650...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1650 Ophthalmic bar prism. (a) Identification. An ophthalmic bar prism is a device that is a bar composed of fused prisms of gradually increasing...

  15. 21 CFR 886.1665 - Ophthalmic rotary prism.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ophthalmic rotary prism. 886.1665 Section 886.1665...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1665 Ophthalmic rotary prism. (a) Identification. An ophthalmic rotary prism is a device with various prismatic powers intended to be handheld and...

  16. 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...

  17. 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...

  18. 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...

  19. 21 CFR 886.1650 - Ophthalmic bar prism.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic bar prism. 886.1650 Section 886.1650...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1650 Ophthalmic bar prism. (a) Identification. An ophthalmic bar prism is a device that is a bar composed of fused prisms of gradually increasing...

  20. 21 CFR 886.3100 - Ophthalmic tantalum clip.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ophthalmic tantalum clip. 886.3100 Section 886...) 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...

  1. 21 CFR 886.3100 - Ophthalmic tantalum clip.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic tantalum clip. 886.3100 Section 886...) 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...

  2. 21 CFR 886.3100 - Ophthalmic tantalum clip.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic tantalum clip. 886.3100 Section 886...) 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...

  3. 21 CFR 886.3100 - Ophthalmic tantalum clip.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic tantalum clip. 886.3100 Section 886...) 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...

  4. 21 CFR 886.3100 - Ophthalmic tantalum clip.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ophthalmic tantalum clip. 886.3100 Section 886...) 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...

  5. 21 CFR 886.1405 - Ophthalmic trial lens set.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 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...

  6. 21 CFR 886.1405 - Ophthalmic trial lens set.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 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...

  7. 21 CFR 886.1405 - Ophthalmic trial lens set.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 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...

  8. 21 CFR 886.1405 - Ophthalmic trial lens set.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 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...

  9. 21 CFR 886.1410 - Ophthalmic trial lens clip.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 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,...

  10. 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... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4350 Manual ophthalmic surgical instrument. (a) Identification. A manual ophthalmic surgical instrument is a nonpowered, handheld...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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,...

  17. 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...

  18. 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...

  19. Dry Eye and Designer Ophthalmics

    PubMed Central

    Laurie, Gordon W.; Olsakovsky, Leslie A.; Conway, Brian P.; McKown, Robert L.; Kitagawa, Kazuko; Nichols, Jason J.

    2009-01-01

    EST, proteomic, and antibody capture assays are revealing a level of tear film protein complexity far greater than previously appreciated. A systems biology approach will be needed to fully appreciate function as tear protein doses fluctuate in time through different conditions. Although consensus is growing on what fully constitutes the human tear proteome, questions remain about the source and significance of the ∼256 tear proteins designated as ‘intracellular’. Many of these may derive from normal cellular turnover and could therefore be informative. A further >183 are designated as ‘extracellular’. Surprisingly, only 4 – 5% of these appear to be dysregulated in the three forms of dry eye preliminarily examined to date. Some differ and a couple overlap, suggesting that disease-specific signatures could be identified. Future dry eye treatment might include recombinant tear protein rescue as a personalized ophthalmic approach to ocular surface disease. PMID:18677231

  20. Big data and ophthalmic research.

    PubMed

    Clark, Antony; Ng, Jonathon Q; Morlet, Nigel; Semmens, James B

    2016-01-01

    Large population-based health administrative databases, clinical registries, and data linkage systems are a rapidly expanding resource for health research. Ophthalmic research has benefited from the use of these databases in expanding the breadth of knowledge in areas such as disease surveillance, disease etiology, health services utilization, and health outcomes. Furthermore, the quantity of data available for research has increased exponentially in recent times, particularly as e-health initiatives come online in health systems across the globe. We review some big data concepts, the databases and data linkage systems used in eye research-including their advantages and limitations, the types of studies previously undertaken, and the future direction for big data in eye research.

  1. Development and Evaluation of Diclofenac Sodium Loaded-N-Trimethyl Chitosan Nanoparticles for Ophthalmic Use.

    PubMed

    Asasutjarit, Rathapon; Theerachayanan, Thitaree; Kewsuwan, Prartana; Veeranodha, Sukitaya; Fuongfuchat, Asira; Ritthidej, Garnpimol C

    2015-10-01

    The ophthalmic preparation of diclofenac sodium (DC) for relieving ocular inflammation is presently available in the market only as an eye drop solution. Due to its low occular bioavailability, it requires frequent application leading to low patients' compliance and quality of life. This study was conducted to develop formulations of DC loaded-N-trimethyl chitosan nanoparticles (DC-TMCNs) for ophthalmic use to improve ocular biavailabiltiy of DC. DC-TMCNs varied in formulation compositions were prepared using ionic gelation technique and evaluated for their physicochemical properties, drug release, eye irritation potential, and ophthalmic absorption of diclofenac sodium. N-Trimethyl chitosan (TMC) with a 49.8% degree of quaternization was synthesized and used for DC-TMCNs production. The obtained DC-TMCNs had particle size in a range of 130-190 nm with zeta potential values of +4 to +9 mV and drug entrapment efficiencies of more than 70% depending on the content of TMC and sodium tripolyphosphate (TPP). The optimized DC-TMCNs formulation contained TMC, DC, and TPP at a weight ratio of TMC/DC/TPP = 3:1:1. Their lyophilized product reconstituted with phosphate buffer solution pH 5.5 possessed a drug release pattern that fitted within the zero-order model. The eye irritation tests showed that DC-TMCNs were safe for ophthalmic use. The in vivo ophthalmic drug absorption study performed on rabbits indicated that DC-TMCNs could improve ophthalmic bioavailability of DC. Results of this study suggested that DC-TMCNs had potential for use as an alternative to conventional DC eye drops for ophthalmic inflammation treatment.

  2. Transcutaneous Puncture of the Superior Ophthalmic Vein for Embolization of Dural Carotid-Ophthalmic Fistula

    PubMed Central

    Chen, Wen-Hsien; Tsai, I-Chen; Huang, Hou-Chi; Lin, Chun-Han; Hung, Hao-Chun; Wu, Chen-Hao; Chi-Chang Chen, Clayton

    2008-01-01

    Summary Carotid-ophthalmic fistula is a rare disease, which can be treated by transvenous endovascular embolization. Here, we report a unique case with draining vein thrombosed, making a transvenous approach impossible. An old but valuable technique, direct transcutaneous puncture of the superior ophthalmic vein, was used to save the patient's right eye. The old technique, direct puncture of the superior ophthalmic vein, retains its irreplaceable usefulness in this special situation. Thus, interventional neuroradiologists should equip themselves with this essential technique. PMID:20557794

  3. Paradigm Shifts in Ophthalmic Diagnostics*

    PubMed Central

    Sebag, J.; Sadun, Alfredo A.; Pierce, Eric A.

    2016-01-01

    Purpose Future advances in ophthalmology will see a paradigm shift in diagnostics from a focus on dysfunction and disease to better measures of psychophysical function and health. Practical methods to define genotypes will be increasingly important and non-invasive nanotechnologies are needed to detect molecular changes that predate histopathology. Methods This is not a review nor meant to be comprehensive. Specific topics have been selected to illustrate the principles of important paradigm shifts that will influence the future of ophthalmic diagnostics. It is our impression that future evaluation of vision will go beyond visual acuity to assess ocular health in terms of psychophysical function. The definition of disease will incorporate genotype into what has historically been a phenotype-centric discipline. Non-invasive nanotechnologies will enable a paradigm shift from disease detection on a cellular level to a sub-cellular molecular level. Results Vision can be evaluated beyond visual acuity by measuring contrast sensitivity, color vision, and macular function, as these provide better insights into the impact of aging and disease. Distortions can be quantified and the psychophysical basis of vision can be better evaluated than in the past by designing tests that assess particular macular cell function(s). Advances in our understanding of the genetic basis of eye diseases will enable better characterization of ocular health and disease. Non-invasive nanotechnologies can assess molecular changes in the lens, vitreous, and macula that predate visible pathology. Oxygen metabolism and circulatory physiology are measurable indices of ocular health that can detect variations of physiology and early disease. Conclusions This overview of paradigm shifts in ophthalmology suggests that the future will see significant improvements in ophthalmic diagnostics. The selected topics illustrate the principles of these paradigm shifts and should serve as a guide to further

  4. Paradigm Shifts in Ophthalmic Diagnostics.

    PubMed

    Sebag, J; Sadun, Alfredo A; Pierce, Eric A

    2016-08-01

    Future advances in ophthalmology will see a paradigm shift in diagnostics from a focus on dysfunction and disease to better measures of psychophysical function and health. Practical methods to define genotypes will be increasingly important and non-invasive nanotechnologies are needed to detect molecular changes that predate histopathology. This is not a review nor meant to be comprehensive. Specific topics have been selected to illustrate the principles of important paradigm shifts that will influence the future of ophthalmic diagnostics. It is our impression that future evaluation of vision will go beyond visual acuity to assess ocular health in terms of psychophysical function. The definition of disease will incorporate genotype into what has historically been a phenotype-centric discipline. Non-invasive nanotechnologies will enable a paradigm shift from disease detection on a cellular level to a sub-cellular molecular level. Vision can be evaluated beyond visual acuity by measuring contrast sensitivity, color vision, and macular function, as these provide better insights into the impact of aging and disease. Distortions can be quantified and the psychophysical basis of vision can be better evaluated than in the past by designing tests that assess particular macular cell function(s). Advances in our understanding of the genetic basis of eye diseases will enable better characterization of ocular health and disease. Non-invasive nanotechnologies can assess molecular changes in the lens, vitreous, and macula that predate visible pathology. Oxygen metabolism and circulatory physiology are measurable indices of ocular health that can detect variations of physiology and early disease. This overview of paradigm shifts in ophthalmology suggests that the future will see significant improvements in ophthalmic diagnostics. The selected topics illustrate the principles of these paradigm shifts and should serve as a guide to further research and development. Indeed

  5. 21 CFR 886.4690 - Ophthalmic photocoagulator.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Identification. An ophthalmic photocoagulator is an AC-powered device intended to use the energy from an extended noncoherent light source to occlude blood vessels of the retina, choroid, or iris. (b) Classification. Class...

  6. 21 CFR 886.4690 - Ophthalmic photocoagulator.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) Identification. An ophthalmic photocoagulator is an AC-powered device intended to use the energy from an extended noncoherent light source to occlude blood vessels of the retina, choroid, or iris. (b) Classification. Class...

  7. Ophthalmic Artery Occlusion Following Transconjunctival Orbitotomy.

    PubMed

    Ganguly, Anasua; Pappuru, Rajeev Reddy; Ali, Mohammad Javed; Mishra, Dilip Kumar; Naik, Milind N

    Postoperative blindness after orbital surgery is an extremely rare and a disastrous complication. Ophthalmic artery occlusion as a cause of such unexpected vision loss has not been documented in literature. The authors report a case of a middle aged man who developed sudden vision loss due to ophthalmic artery occlusion following transconjunctival excision of orbital schwanomma. The possible mechanisms contributing to the loss of vision are discussed and preventive strategies are suggested to reduce the incidence of this complication.

  8. Microsurgical treatment of ophthalmic segment aneurysms.

    PubMed

    Gross, Bradley A; Du, Rose

    2013-08-01

    Ophthalmic segment aneurysms refer to superior hypophyseal artery aneurysms, true ophthalmic artery aneurysms, and their dorsal variant. Indications for treatment of these aneurysms include concerning morphological features, large size, visual loss, or rupture. Although narrow-necked aneurysms are ideal endovascular targets, more complex and larger lesions necessitating adjunctive stent or flow-diversion techniques may be suitably treated with long-lasting, effective clip ligation instead. This is particularly relevant in the consideration of ruptured ophthalmic segment aneurysms. This article provides a depiction of microsurgical treatment of ophthalmic segment aneurysms with an accompanying video demonstration. Emphasis is placed on microsurgical anatomy, the intradural anterior clinoidectomy and clipping technique. The intradural anterior clinoidectomy, demonstrated in detail in our Supplementary video, provides significant added exposure of the ophthalmic segment of the internal carotid artery, allowing for improved aneurysm visualization. In the management of superior hypophyseal artery aneurysms, emphasis is placed on identifying and preserving superior hypophyseal artery perforators, using serial fenestrated straight clips rather than a single right-angled fenestrated clip to obliterate the aneurysm. Post-clipping indocyanine green dye angiography is a crucial tool to confirm aneurysm obliteration and the preservation of the parent vasculature and adjacent superior hypophyseal artery perforators. With careful attention to the nuances of microsurgical clipping of ophthalmic segment aneurysms, rewarding results can be obtained.

  9. Cleaning of ophthalmic diamond scalpels.

    PubMed

    Beran, R F

    1994-01-01

    To ensure optimal performance, it is imperative to properly maintain the condition of ophthalmic diamond scalpels. Refractive surgeons are often confronted with conflicting cleaning recommendations from manufacturers. The problem encountered is to maximize cleaning while minimizing trauma to the diamond to maintain its longevity. The author describes a flexible graded approach to cleaning and maintaining diamond scalpels. The principle of this approach was the development of four successive levels of cleaning based on an increasing risk of trauma to the diamond: Level I--irrigation with distilled water, Level II--hydrogen peroxide or enzyme cleaning, Level III--ultrasonic and detergent cleaning, and Level IV--mechanical styrofoam block cleaning. The protocol was performed prospectively on 50 consecutive radial keratotomy cases, inspecting the blade microscopically after each cleaning step, and determining the level at which cleanliness of the blade was achieved. The effectiveness (clean/dirty) of each cleaning level was evaluated by the author and an experienced surgical assistant. The difficulty in accurately measuring the amount of debris and the force necessary to remove it, limited the judgments made to subjective observation. Only 2 of 50 blades were cleaned at Level I, while 41 of 48 at Level III, and 7 of 7 at Level IV. A multi-leveled systematic process for cleaning maintenance appears most effective for maximal performance and longevity of diamond scalpels used for refractive keratotomy surgery.

  10. 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.

  11. Ion-activated in situ gelling systems for sustained ophthalmic delivery of ciprofloxacin hydrochloride.

    PubMed

    Balasubramaniam, J; Pandit, J K

    2003-01-01

    The poor bioavailability and therapeutic response exhibited by the conventional ophthalmic solutions due to precorneal elimination of the drug may be overcome by the use of in situ gel forming systems that are instilled as drops into the eye and undergo a sol-gel transition in the cul-de-sac. Our present work describes the formulation and evaluation of an ophthalmic delivery system of an antibacterial agent, CPH, based on the concept of ion-activated in situ gelation. Gelrite gellan gum, a novel ophthalmic vehicle that gels in the presence of mono or divalent cations, present in the lacrimal fluid was used alone and in combinations with sodium alginate as the gelling agent. The developed formulations were therapeutically efficacious and provided sustained release of the drug over an 8-hr period in vitro.

  12. 21 CFR 886.4855 - Ophthalmic instrument table.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Identification. An ophthalmic instrument table is an AC-powered or manual device on which ophthalmic instruments are intended to be placed. (b) Classification. Class I (general controls). The AC-powered device...

  13. 75 FR 36101 - Dermatologic and Ophthalmic Drugs Advisory Committee; Cancellation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-24

    ... HUMAN SERVICES Food and Drug Administration 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 scheduled for June 28, 2010, is cancelled. This...

  14. 21 CFR 886.4770 - Ophthalmic operating spectacles (loupes).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (loupes). (a) Identification. Ophthalmic operating spectacles (loupes) are devices that consist of convex lenses or lens systems intended to be worn by a surgeon to magnify the surgical site during ophthalmic...

  15. Light Levels In Ophthalmic Diagnostic Instruments

    NASA Astrophysics Data System (ADS)

    Delori, Francois C.; Pomerantzeff, Oleg; Mainster, Martin A.

    1980-10-01

    Methods are presented for determining the retinal exposures produced by broad-band ophthalmic light sources and for comparing these results with safety standards developed for the safe use of lasers (ANSI, Z136.1). Measurements of exposures produced by fundus cameras and indirect ophthalmoscopes are compared with both Z136.1 maximum permissible exposure levels (MPE) and experimental retinal damage thresholds. It is found that while the retinal exposures used in fundus photography are below MPEs, the irradiances used in indirect ophthalmoscopy may actually equal or exceed current MPEs. Methods are suggested for reducing retinal irradiance while maintaining retinal image luminance, and emphasis is placed on the importance of both acquainting the users of ophthalmic devices with any potential retinal hazard and providing the users and designers of ophthalmic devices with realistic protection standards.

  16. Ophthalmic manifestations of paranasal sinus mucocoeles.

    PubMed

    Sadiq, S Ahmed; Lim, M Kim; Jones, Nicholas S

    2009-04-01

    To investigate the ophthalmic manifestations of paranasal sinus mucocoeles. A retrospective study of all patients (1992-1998) diagnosed with paranasal sinus mucocoeles. All patients had a CT scan. Of the 45 patients, only 3 (6.7%) did not have ophthalmic symptoms or signs. The most common (64.4%) presenting feature was peri-orbital swelling, often associated with pain and tenderness. Other presenting features included diplopia, proptosis, hypoglobus, diplopia, decreased colour vision, epiphora, facial swelling and nasal polyps. The frontal sinus was the most commonly (70%) involved site. Paranasal sinus mucocoeles present most commonly with ophthalmic symptoms and signs. Patients with this condition are therefore highly likely to present initially to the ophthalmology department. Awareness of the aetiology of this condition is important so that appropriate and timely referral is made to the otolaryngologists to ensure appropriate management of this condition.

  17. Ophthalmic masquerades of the atherosclerotic carotids

    PubMed Central

    Arthur, Anupriya; Alexander, Anika; Bal, Simerpreet; Sivadasan, Ajith; Aaron, Sanjith

    2014-01-01

    Patients with carotid atherosclerosis can present with ophthalmic symptoms. These symptoms and signs can be due to retinal emboli, hypoperfusion of the retina and choroid, opening up of collateral channels, or chronic hypoperfusion of the globe (ocular ischemic syndrome). These pathological mechanisms can produce many interesting signs and a careful history can bring out important past symptoms pointing toward the carotid as the source of the patient's presenting symptom. Such patients are at high risk for an ischemic stroke, especially in the subsequent few days following their first acute symptom. It is important for clinicians to be familiar with these ophthalmic symptoms and signs caused by carotid atherosclerosis for making an early diagnosis and to take appropriate measures to prevent a stroke. This review elaborates the clinical features, importance, and implications of various ophthalmic symptoms and signs resulting from atherosclerotic carotid artery disease. PMID:24817748

  18. 21 CFR 886.1415 - Ophthalmic trial lens frame.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 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...

  19. 21 CFR 886.1415 - Ophthalmic trial lens frame.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 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...

  20. 21 CFR 886.1415 - Ophthalmic trial lens frame.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 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...

  1. 21 CFR 886.1415 - Ophthalmic trial lens frame.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 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...

  2. 21 CFR 886.4250 - Ophthalmic electrolysis unit.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...) 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... battery-powered device. Class II for the AC-powered device. The battery-powered device is exempt from...

  3. 21 CFR 886.4250 - Ophthalmic electrolysis unit.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) 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... battery-powered device. Class II for the AC-powered device. The battery-powered device is exempt from...

  4. 21 CFR 886.4250 - Ophthalmic electrolysis unit.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) 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... battery-powered device. Class II for the AC-powered device. The battery-powered device is exempt from...

  5. 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....

  6. 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 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....

  7. 21 CFR 886.5800 - Ophthalmic bar reader.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 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....

  8. 21 CFR 886.5800 - Ophthalmic bar reader.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 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....

  9. 21 CFR 886.5800 - Ophthalmic bar reader.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 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....

  10. 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...

  11. 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.

  12. 21 CFR 349.14 - Ophthalmic emollients.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... included in the monograph. (8) Yellow wax, up to 5 percent in combination with one or more other emollient... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Ophthalmic emollients. 349.14 Section 349.14 Food...) Paraffin, up to 5 percent in combination with one or more other emollient agents included in the...

  13. 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.

  14. 21 CFR 349.12 - Ophthalmic demulcents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Ophthalmic demulcents. 349.12 Section 349.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR...) Polyethylene glycol 300, 0.2 to 1 percent. (3) Polyethylene glycol 400, 0.2 to 1 percent. (4) Polysorbate 80, 0...

  15. 21 CFR 349.12 - Ophthalmic demulcents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Ophthalmic demulcents. 349.12 Section 349.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR...) Polyethylene glycol 300, 0.2 to 1 percent. (3) Polyethylene glycol 400, 0.2 to 1 percent. (4) Polysorbate 80, 0...

  16. 21 CFR 886.3130 - Ophthalmic conformer.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic conformer. 886.3130 Section 886.3130 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... adhesions during the healing process following surgery. ] (b) Classification. Class II (special controls...

  17. 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.

  18. Safety of Besifloxacin Ophthalmic Suspension 0.6% in Cataract and LASIK Surgery Patients

    PubMed Central

    Clinch, Thomas E.

    2014-01-01

    Purpose: The aim of the study was to evaluate the safety of besifloxacin ophthalmic suspension 0.6% as antibacterial prophylaxis in the surgical setting. Methods: Two prospective safety surveillance studies were conducted—one in the cataract surgery setting and the other in the laser-assisted in situ keratomileusis (LASIK) surgery setting. Cases from patients aged 18 years and above were eligible for inclusion. In both surveillance studies, data were collected from consecutive cases of routine primary cataract surgery and LASIK surgery, respectively, in which besifloxacin ophthalmic suspension 0.6% or moxifloxacin ophthalmic solution 0.5% was used as the topical perioperative prophylactic antibacterial medication as part of the clinician's routine standard of care. The primary safety endpoint was the incidence of treatment-emergent adverse events (TEAEs). Results: The cataract surgery surveillance study included 485 cases/eyes (besifloxacin, n = 333; moxifloxacin, n = 152), whereas the LASIK surveillance study included 456 cases/eyes (besifloxacin, n = 344; moxifloxacin, n = 112). In the cataract study, only 1 TEAE was reported in a besifloxacin case (mild hypersensitivity/allergic reaction considered possibly related to besifloxacin). No TEAEs were reported in the LASIK study. In both studies, surgical outcomes were similar with both treatments. The frequency of preoperative and/or postoperative dosing was generally lower for besifloxacin than that for moxifloxacin. Conclusions: In prospective safety surveillance studies of patients undergoing cataract extraction or LASIK, TEAEs associated with prophylactic use of besifloxacin ophthalmic suspension 0.6% were rare, and surgical outcomes with besifloxacin were similar to those with moxifloxacin ophthalmic solution 0.5%. PMID:24637269

  19. 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

  20. Application of ultrasound microbubble contrast technology in ophthalmic targeted therapy: literature analysis.

    PubMed

    Yuan, Jia-Ying; Zhang, Jian-Hua; Tang, Chong; Zhu, Hong; Xie, Hua; Gao, Shuan-Jie

    2011-01-01

    To analyze the application of microbubble contrast technology in the treatment of ophthalmic diseases, mainly analyzing its advantages and existing problems. A total of 30 representative literatures about the application of ultrasound contrast agent in gene targeted therapy at home and abroad were collected, and focusing on sorting out the literature reporting the treatment of ophthalmic diseases with microbubble contrast technology in recent years, then recalling its advantages and problems, finally making reasonable assessment on existing problems and proposing possible solutions to the problems. DUE TO ITS UNIQUE SAFETY AND EFFICACY, THE TREATMENT OF OPHTHALMIC DISEASES WITH MICROBUBBLE CONTRAST TECHNOLOGY HAS INCREASINGLY DRAWN THE ATTENTION OF CLINICIANS, BUT TWO RELEVANT ISSUES SHOULD BE CONSIDERED: first, the nature of contrast agent and the choice of corresponding ultrasound parameters; second, relative incidence of tissue bleeding, intravascular hemolysis, moderate or severe allergy as well as other side effects. Microbubble may become the carrier of targeted therapy, and as a kind of new non-invasive delivery system, the ultrasound contrast agent has broad application prospects, but its application in ophthalmic research is still in its initial stage and the safety of contrast-enhanced ultrasound still needs further study.

  1. Vitamin B2-sensitised photooxidation of the ophthalmic drugs Timolol and Pindolol: kinetics and mechanism.

    PubMed

    Criado, Susana; García, Norman A

    2004-01-01

    The kinetics and mechanistic aspects of the riboflavin-photosensitised oxidation of the topically administrable ophthalmic drugs Timolol (Tim) and Pindolol (Pin) were investigated in water-MeOH (9:1, v/v) solution employing light of wavelength > 400 nm. riboflavin, belonging to the vitamin B(2) complex, is a known human endogenous photosensitiser. The irradiation of riboflavin in the presence of ophthalmic drugs triggers a complex picture of competitive reactions which produces the photodegradation of both the drugs and the pigment itself. The mechanism was elucidated employing stationary photolysis, polarographic detection of dissolved oxygen, stationary and time-resolved fluorescence spectroscopy, and laser flash photolysis. Ophthalmic drugs quench riboflavin-excited singlet and triplet states. From the quenching of excited triplet riboflavin, the semireduced form of the pigment is generated, through an electron transfer process from the drug, with the subsequent production of superoxide anion radical (O(2)(*-)) by reaction with dissolved molecular oxygen. Through the interaction of dissolved oxygen with excited triplet riboflavin, the species singlet oxygen (O(2)((1)Delta(g))) is also generated to a lesser extent. Both O(2)(*-) and O(2)((1)Delta(g)) induce photodegradation of ophthalmic drugs, Tim being approximately 3-fold more easily photooxidisable than Pin, as estimated by oxygen consumption experiments.

  2. 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.

  3. Anatomy of the Ophthalmic Artery: Embryological Consideration

    PubMed Central

    TOMA, Naoki

    2016-01-01

    There are considerable variations in the anatomy of the human ophthalmic artery (OphA), such as anomalous origins of the OphA and anastomoses between the OphA and the adjacent arteries. These anatomical variations seem to attribute to complex embryology of the OphA. In human embryos and fetuses, primitive dorsal and ventral ophthalmic arteries (PDOphA and PVOphA) form the ocular branches, and the supraorbital division of the stapedial artery forms the orbital branches of the OphA, and then numerous anastomoses between the internal carotid artery (ICA) and the external carotid artery (ECA) systems emerge in connection with the OphA. These developmental processes can produce anatomical variations of the OphA, and we should notice these variations for neurosurgical and neurointerventional procedures. PMID:27298261

  4. Anatomy of the Ophthalmic Artery: Embryological Consideration.

    PubMed

    Toma, Naoki

    2016-10-15

    There are considerable variations in the anatomy of the human ophthalmic artery (OphA), such as anomalous origins of the OphA and anastomoses between the OphA and the adjacent arteries. These anatomical variations seem to attribute to complex embryology of the OphA. In human embryos and fetuses, primitive dorsal and ventral ophthalmic arteries (PDOphA and PVOphA) form the ocular branches, and the supraorbital division of the stapedial artery forms the orbital branches of the OphA, and then numerous anastomoses between the internal carotid artery (ICA) and the external carotid artery (ECA) systems emerge in connection with the OphA. These developmental processes can produce anatomical variations of the OphA, and we should notice these variations for neurosurgical and neurointerventional procedures.

  5. Are we pharmacovigilant enough in ophthalmic practice?

    PubMed

    Dubey, Ashok; Handu, Shailendra S

    2013-05-01

    No drug is absolutely safe. Pharmacovigilance is the science related to detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems. The ocular medications and devices can cause localized and systemic adverse effects. Not all adverse effects are known when a drug or device is launched in market because of limitations of clinical trials. Many adverse effects are recognized due to the spontaneous reporting of the vigilant doctors who observe and report such events encountered in their practice. Despite a large ophthalmic patient population base, India does not have robust adverse drug reaction (ADR) database because of lack of reporting culture. Government of India recently launched the Pharmacovigilance Programme of India (PvPI) to monitor ADRs and create awareness among the healthcare professionals about the importance of ADRs. Suspecting and reporting a possible drug reaction is very important in developing a safe and rational ophthalmic practice.

  6. [Development of ophthalmic pathology and precision medicine].

    PubMed

    Li, Y P; Li, B

    2016-10-11

    As an indispensable professional, ophthalmic pathology plays an important role in the development of the ophthalmology. With the worldwide attention and promotion of precision medicine and the rapid development of modern medical testing technology, the development of pathology is facing the challenges of survival and development opportunities. We discuss the relationship between the development of pathology and the precision medicine to explain that the precise pathological diagnosis is the basis of the implementation of precision medicine. Ophthalmic pathology workers should be the first to improve the accuracy of the diagnosis of ocular diseases, in order to play a greater role in the future of precision medicine in the diagnosis of pathology. (Chin J Ophthalmol, 2016, 52: 724-727).

  7. Neuro-ophthalmic deficits after head trauma.

    PubMed

    Jacobs, Sarah M; Van Stavern, Gregory P

    2013-11-01

    Head trauma can injure the afferent and/or efferent visual systems, resulting in neuro-ophthalmic deficits. When assessing afferent pathway injuries, a stepwise approach to evaluating visual acuity, pupils, color perception, and visual fields is critical. Traumatic optic neuropathy is of especial importance and its management must be tailored on a case-by-case basis. Efferent pathway injuries should be assessed with attention to abnormalities of ocular alignment and motility, which may occur as isolated deficits or as part of a recognizable syndrome. Concussion or diffuse axonal injuries may also affect ophthalmologic function. Here, we review the extant literature describing the assessment and acute treatment of traumatic neuro-ophthalmic deficits.

  8. Ophthalmic plastic and orbital surgery in Taiwan.

    PubMed

    Hsu, Chi-Hsin; Lin, I-Chan; Shen, Yun-Dun; Hsu, Wen-Ming

    2014-06-01

    We describe in this paper the current status of ophthalmic plastic and orbital surgery in Taiwan. Data were collected from the Bureau of National Health Insurance of Taiwan, the Bulletin of the Taiwan Ophthalmic Plastic and Reconstructive Society, and the Statistics Yearbook of Practicing Physicians and Health Care Organizations in Taiwan by the Taiwan Medical Association. We ascertained that 94 ophthalmologists were oculoplastic surgeons and accounted for 5.8% of 1621 ophthalmologists in Taiwan. They had their fellowship training abroad (most ophthalmologists trained in the United States of America) or in Taiwan. All ophthalmologists were well trained and capable of performing major oculoplastic surgeries. The payment rates by our National Health Insurance for oculoplastic and orbital surgeries are relatively low, compared to Medicare payments in the United States. Ophthalmologists should promote the concept that oculoplastic surgeons specialize in periorbital plastic and aesthetic surgeries. However, general ophthalmologists should receive more educational courses on oculoplastic and cosmetic surgery.

  9. 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.

  10. [Immunohistochemistry in ophthalmic pathology: applications and limitations].

    PubMed

    Pluot, M; Cahn, V; Ducasse, A

    2006-10-01

    We evaluate the applications of immunohistochemistry (IHC) in ophthalmic cytology and pathology. The principles of the techniques used in IHC are described. Recent improvements are highlighted, such as the polymeric labeling two-step method, tyramine signal amplification, rabbit monoclonal antibodies, and labeled nanocrystals. The results of the immunohistochemical methods are collected in bacterial and viral diseases and in tumors of the eye and its adnexa, the pathology of which varies greatly. The results in lymphomas, melanomas, and palpebral tumors were more details for practical reasons. There are widespread applications of IHC in ophthalmic pathology, extending from viral ocular and general diseases to the diagnosis of tumors. In some conditions, this technique needs to be associated with molecular biology investigations. Automation helps establish standard protocols, but IHC is a multistep diagnostic method requiring proper selection, fixation, processing, and staining procedures. From a general standpoint, good communication between pathologists and ophthalmologists is the best guarantee of satisfying results.

  11. Ophthalmic clues to the endocrine disorders.

    PubMed

    Liu, Z; Chen, Y; Lin, Z; Shi, X

    2017-01-01

    Eye is a vital sense organ and reflects the physical and mental wellbeing of a person. Detailed examination of the eye is an essential part in the clinical evaluation of patients with any systemic disorder. The interaction between ophthalmologists and endocrinologists is often limited to Graves' ophthalmopathy and diabetic retinopathy. However, there are many ophthalmic manifestations, which are characteristically seen in endocrine disorders. In this review, we shall discuss the ocular manifestations of the endocrine syndromes excluding the Graves' ophthalmopathy and diabetic retinopathy. We performed a PubMed search of articles published in English showing the ophthalmic features in the endocrine disorders. Relevant cited articles were also retrieved. Most of the publications included in the review were case reports and review articles. Many endocrine disorders have characteristic manifestations pertaining to the various structures of the eye. The involvement is seen from the external structures of the eye to the inner most layers of the retina. Many ocular-endocrine syndromes also exist with characteristic clues to the clinical diagnosis. The endocrinologists need to be aware of these ocular signs that help in the early diagnosis of the underlying disorder. A syndromic approach is essential in the diagnosis of endocrinopathy in patients presenting with ophthalmic features.

  12. 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.

  13. Sorption of benzalkonium chloride to various filters used in processing ophthalmics.

    PubMed

    Prince, S J; Allen, L V

    1998-01-01

    Benzalkonium chloride is widely used as a preservative in ophthalmic formulations. The United Stated Pharmacopeia XXIII/National Formulary 18 states that "sterile membrane filtration under aseptic conditions is the preferred method" for sterilization of ophthalmic products, and sorption of benzalkonium chloride to filters has presented a problem in ophthalmic processing. The purpose of this study was to determine the extent of, and factors affecting, benzalkonium chloride sorption to filters. An aqueous solution of benzalkonium chloride 0.2 mg/mL was passed through syringe filters of various sizes, filter membrane media and manufacturers. The filters were of four sizes: 13- or 25-mm diameter with 0.2- or 0.45-micrometer pores. The filter membrane media were nylon, polyvinylidene fluoride (PVDF), polyethersulfone (PES) or polytetrafluoroethylene (PTFE) manufactured by Gelman Sciences or Micron Separations, Inc. A total volume of 3.6 mL in 0.6-mL increments was filtered, followed by a 1.8-mL water rinse. Samples were then analyzed by high-performance liquid chromatography. The results showed a significant difference in sorption based on all three variables. The 13-mm diameter filters absorbed less drug than the 25-mm filters, and filters with 0.45-micrometer pores adsorbed less drug than those with 0.2-micrometer pores because of smaller surface area exposed. The following sorption pattern was observed for the filter media: PVDF greater than PTFE greater than nylon greater than PES, with Micron Separations nylon filters showing a higher degree of sorption than Gelman Sciences nylon filters. The appropriate filter media and size should be chosen for ophthalmic product filtration to minimize loss of benzalkonium chloride in processing ophthalmic products.

  14. 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

  15. Sustained ophthalmic delivery of ofloxacin from an ion-activated in situ gelling system.

    PubMed

    Abraham, Sindhu; Furtado, Sharon; Bharath, S; Basavaraj, B V; Deveswaran, R; Madhavan, V

    2009-04-01

    The poor bioavailability and therapeutic response exhibited by conventional ophthalmic solutions due to rapid pre-corneal elimination of the drug may be overcome by the use of in situ gel forming systems that are instilled as drops into the eye and then undergo a sol-gel transition in the cul-de-sac. The present work describes the formulation and evaluation of an ophthalmic delivery system of an antibacterial agent ofloxacin, based on the concept of ion-activated in situ gelation. Sodium alginate was used as the gelling agent in combination with HPC (Hydroxy Propyl Cellulose) that acted as a viscosity-enhancing agent. In vitro release studies indicated that the alginate/HPC solution retained the drug better than the alginate or HPC solutions alone. The formulations were therapeutically efficacious, sterile, stable and provided sustained release of the drug over a period of time. These results demonstrate that the developed system is an alternative to conventional ophthalmic drops, patient compliance, industrially oriented and economical.

  16. Investigation of Somatic GNAQ, GNA11, BAP1 and SF3B1 Mutations in Ophthalmic Melanocytomas.

    PubMed

    Francis, Jasmine H; Wiesner, Thomas; Milman, Tatyana; Won, Helen H; Lin, Amy; Lee, Vivian; Albert, Daniel M; Folberg, Robert; Berger, Michael F; Char, Devron H; Marr, Brian; Abramson, David H

    2016-04-01

    The aim of this study was to use massively parallel DNA sequencing to identify GNAQ/11, BAP1 and SF3B1 mutations in ophthalmic melanocytoma. Six ophthalmic melanocytoma specimens (1 iridociliary and 5 optic nerve) were profiled for genomic alterations in GNAQ/11, BAP1 and SF3B1 using a custom deep sequencing assay. This assay uses solution phase hybridization-based exon capture and deep-coverage massively parallel DNA sequencing to interrogate all protein-coding exons and select introns. The only iridociliary melanocytoma showed a mutation in GNAQ but not in BAP1. Of the 2 optic-nerve melanocytomas that developed into melanoma, one had a GNAQ mutation and both a BAP1 mutation and monosomy 3. The remaining 3 optic-nerve melanocytomas did not reveal mutations in GNAQ/11 or BAP1. SF3B1 mutations were not detected in any specimen. The presence of GNAQ mutation in some iridociliary and optic-nerve melanocytomas suggests a possible relationship between ophthalmic melanocytoma and other ophthalmic melanocytic neoplasms. BAP1 mutation may accompany the transformation of ophthalmic melanocytoma to melanoma.

  17. Review of null hypothesis significance testing in the ophthalmic literature: are most 'significant' P values false positives?

    PubMed

    Sanfilippo, Paul G; Casson, Robert J; Yazar, Seyhan; Mackey, David A; Hewitt, Alex W

    2016-01-01

    P values associated with null hypothesis significance testing (NHST) are almost universal in the ophthalmic literature. A P value < 0.05 is traditionally considered 'significant'. This concept may deflect further thought about the veracity of the results. P values influence the publishability of the data and have flow-on effects for funding success and the direction of future research. Despite their importance, the problems inherent in P values have been recognized since their inception, and in more recent years have been increasingly highlighted in some scientific fields. In this review, we aim to bring the problems associated with P values and NHST to the attention of the ophthalmic research community. We do not offer a universal solution to the problem of determining the veracity of a scientific claim; however, we demonstrate the need for caution in interpreting 'significant' P values by performing a Bayesian re-analysis of t-tests in the ophthalmic literature.

  18. Current Practice of Ophthalmic Anesthesia in Nigeria

    PubMed Central

    Adekoya, Bola J; Onakoya, Adeola O; Balogun, Bola G; Oworu, Olugbemisola

    2013-01-01

    Purpose: To assess the current techniques of ophthalmic anesthesia in Nigeria. Materials and Methods: A cross sectional survey among Nigerian ophthalmology delegates attending the 36th Annual Scientific Congress of the Ophthalmology Society of Nigeria. Self administered and anonymous questionnaires were used and data were collected to include details of the institution, preferred local anesthesia techniques, the grade of doctor who administers the local anesthesia, complications, preferred facial block techniques (if given separately), and type of premedication (if used). Results: Out of the 120 questionnaires distributed, 81 forms were completed (response rate 67.5%). Out of the 74 who indicated their grade, 49 (66.2%) were consultants, 22 (29.7%) were trainees, and 3 (7.1%) were ophthalmic medical officers. For cataract surgery, peribulbar anesthesia was performed by 49.1% of the respondents, followed by retrobulbar anesthesia (39.7%). Others techniques used were topical anesthesia (5.2%), subtenon anesthesia (4.3%), subconjunctival anesthesia (2.6%), and intracameral anesthesia (0.9%). For glaucoma surgery, 47.2% of the respondents use peribulbar anesthesia, 32.1% use retrobulbar anesthesia, 9.4% used general anesthesia, and 6.6% used subconjunctival anesthesia. Among the trainees, 57.8% routinely perform retrobulbar anesthesia while 55.6% routinely perform peribulbar anesthesia. At least one complication from retrobulbar anesthesia within 12 months prior to the audit was reported by 25.9% of the respondents. Similarly, 16.1% of the respondents had experienced complications from peribulbar anesthesia within the same time period. Retrobulbar hemorrhage is the most common complication experienced with both peribulbar and retrobulbar anesthesia. Conclusion: Presently, the most common technique of local anesthesia for an ophthalmic procedure in Nigeria is peribulbar anesthesia, followed by retrobulbar anesthesia. Twelve months prior to the study, 25.9% of the

  19. [Novelty of vital dyes in ophthalmic surgery].

    PubMed

    Rejdak, Robert; Oleszczuk, Agnieszka; Mańkowska, Anna; Kiczyńska, Magdalena; Zagórski, Zbigniew; Zarnowski, Tomasz

    2010-01-01

    The aim of this paper is to present recent developments in the area of novelty of vital dyes in intraocular surgery. The authors present the advantages and disadvantages of several vital dyes currently used in ophthalmic surgery. Vital dyes are used to allow better intraoperative visualization of both the anterior and posterior segments. Indocyanine green and trypan blue are the most frequently used and the most efficacious dyes for staining the important anatomic areas but often are associated with significant side effects. These dyes are used in cataract and vitreo-retinal surgery. Other dyes including rhodamine 6G, E68, bromophenol blue, light green and Chicago blue are still under preclinical assessment.

  20. Ophthalmic management of facial nerve palsy.

    PubMed

    Lee, V; Currie, Z; Collin, J R O

    2004-12-01

    The ophthalmologist plays a pivotal role in the evaluation and rehabilitation of patients with facial nerve palsy. It is crucial to recognize and treat the potentially life-threatening underlying causes. The immediate ophthalmic priority is to ensure adequate corneal protection. The medium to long-term management consists of treatment of epiphora, hyperkinetic disorders secondary to aberrant regeneration and poor cosmesis. Patients should be appropriately referred for general facial re-animation. This review aims to provide a guide to the management of this complex condition.

  1. Ion exchange tempering of glass ophthalmic lenses.

    PubMed

    Keeney, A H; Duerson, H L

    1975-08-01

    We performed low velocity drop-ball tests using 5/8-, 7/8-, and 1-inch diameter steel balls on ophthalmic crown glass lenses chemically tempered by the ion exchange process. Four representative dioptric strengths (+ 2.50 spherical, - 2.50 spherical, -2.50 cylindrical, and plano) were studied with the isolated lenses mounted, convex side up, on the American National Standards Institute Z80 test block. New ion exchange lenses exhibited a 100 to 350% greater capacity for attenuation of energy from low velocity, large size missiles than matched lenses of similar strength prepared by the conventional heat-treating and air-quenching process.

  2. Adjustable fluidic lenses for ophthalmic corrections.

    PubMed

    Marks, Randall; Mathine, David L; Peyman, Gholam; Schwiegerling, Jim; Peyghambarian, Nasser

    2009-02-15

    We report on two fluidic lenses that have been developed for ophthalmic applications. The lenses use a circular aperture to demonstrate optical powers between -20 and +20 D and a rectangular aperture to demonstrate astigmatism with values ranging from 0 to 8 D. Measurements of image quality were made with the fluidic lens using a model eye. Both lenses were variable and controllable by adjusting the fluid volume of the lens. To the best of our knowledge this is the first demonstration of a continuously variable lens for control of astigmatism.

  3. Ophthalmic manifestations of tuberous sclerosis: a review.

    PubMed

    Hodgson, Nickisa; Kinori, Michael; Goldbaum, Michael H; Robbins, Shira L

    2017-01-01

    Tuberous sclerosis or tuberous sclerosis complex (TSC), one of the phakomatoses, is characterized by hamartomas of the heart, kidney, brain, skin and eyes. Ophthalmologic examinations are required in all cases of TSC. Retinal hamartomas are the most common ocular finding in tuberous sclerosis. The majority of hamartomas are non-progressive; however, lesions with subretinal fluid and progression have been reported. This paper details the genetics, clinical features and ocular findings of TSC and reviews potential therapeutic options for ophthalmic manifestations. © 2016 Royal Australian and New Zealand College of Ophthalmologists.

  4. 21 CFR 524.1200a - Kanamycin ophthalmic ointment.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Kanamycin ophthalmic ointment. 524.1200a Section... § 524.1200a Kanamycin ophthalmic ointment. (a) Specifications. The drug, which is in a suitable and harmless ointment base, contains 3.5 milligrams of kanamycin activity (as the sulfate) per gram of...

  5. 21 CFR 524.1200a - Kanamycin ophthalmic ointment.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Kanamycin ophthalmic ointment. 524.1200a Section... § 524.1200a Kanamycin ophthalmic ointment. (a) Specifications. The drug, which is in a suitable and harmless ointment base, contains 3.5 milligrams of kanamycin activity (as the sulfate) per gram of...

  6. 21 CFR 524.1200a - Kanamycin ophthalmic ointment.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Kanamycin ophthalmic ointment. 524.1200a Section... § 524.1200a Kanamycin ophthalmic ointment. (a) Specifications. The drug, which is in a suitable and harmless ointment base, contains 3.5 milligrams of kanamycin activity (as the sulfate) per gram of...

  7. 21 CFR 524.1200a - Kanamycin ophthalmic ointment.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Kanamycin ophthalmic ointment. 524.1200a Section... § 524.1200a Kanamycin ophthalmic ointment. (a) Specifications. The drug, which is in a suitable and harmless ointment base, contains 3.5 milligrams of kanamycin activity (as the sulfate) per gram of...

  8. 21 CFR 886.4350 - Manual ophthalmic surgical instrument.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Manual ophthalmic surgical instrument. 886.4350... instrument. (a) Identification. A manual ophthalmic surgical instrument is a nonpowered, handheld device... trephine. (b) Classification. Class I (general controls). The device is exempt from the...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 21 CFR 200.50 - Ophthalmic preparations and dispensers.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Ophthalmic preparations and dispensers. 200.50... preparations and dispensers. (a)(1) Informed medical opinion is in agreement that all preparations offered or intended for ophthalmic use, including preparations for cleansing the eyes, should be sterile. It...

  15. 21 CFR 200.50 - Ophthalmic preparations and dispensers.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Ophthalmic preparations and dispensers. 200.50... preparations and dispensers. (a)(1) Informed medical opinion is in agreement that all preparations offered or intended for ophthalmic use, including preparations for cleansing the eyes, should be sterile. It...

  16. 21 CFR 200.50 - Ophthalmic preparations and dispensers.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Ophthalmic preparations and dispensers. 200.50... preparations and dispensers. (a)(1) Informed medical opinion is in agreement that all preparations offered or intended for ophthalmic use, including preparations for cleansing the eyes, should be sterile. It...

  17. 21 CFR 200.50 - Ophthalmic preparations and dispensers.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Ophthalmic preparations and dispensers. 200.50... preparations and dispensers. (a)(1) Informed medical opinion is in agreement that all preparations offered or intended for ophthalmic use, including preparations for cleansing the eyes, should be sterile. It...

  18. 21 CFR 349.16 - Ophthalmic hypertonicity agent.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Ophthalmic hypertonicity agent. 349.16 Section 349.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Ophthalmic hypertonicity agent. The active ingredient and its concentration in the product is as follows...

  19. 21 CFR 349.16 - Ophthalmic hypertonicity agent.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Ophthalmic hypertonicity agent. 349.16 Section 349.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Ophthalmic hypertonicity agent. The active ingredient and its concentration in the product is as follows...

  20. 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.

  1. 21 CFR 886.1860 - Ophthalmic instrument stand.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1860 Ophthalmic instrument stand. (a... device and the battery-powered device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The battery-powered device...

  2. 21 CFR 886.1860 - Ophthalmic instrument stand.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1860 Ophthalmic instrument stand. (a... device and the battery-powered device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The battery-powered device...

  3. 21 CFR 886.1860 - Ophthalmic instrument stand.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1860 Ophthalmic instrument stand. (a... device and the battery-powered device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The battery-powered device...

  4. 21 CFR 886.1860 - Ophthalmic instrument stand.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1860 Ophthalmic instrument stand. (a... device and the battery-powered device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The battery-powered device...

  5. 21 CFR 886.1860 - Ophthalmic instrument stand.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1860 Ophthalmic instrument stand. (a... device and the battery-powered device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The battery-powered device...

  6. 21 CFR 524.390 - Chloramphenicol ophthalmic ointment.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Chloramphenicol ophthalmic ointment. 524.390 Section 524.390 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... § 524.390 Chloramphenicol ophthalmic ointment. (a) Specifications. Each gram contains 10 milligrams...

  7. 21 CFR 524.575 - Cyclosporine ophthalmic ointment.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Cyclosporine ophthalmic ointment. 524.575 Section... § 524.575 Cyclosporine ophthalmic ointment. (a) Specifications. Each gram of ointment contains 2... use—(1) Amount. Apply a 1/4-inch strip of ointment to the affected eye(s) every 12 hours. (2...

  8. 21 CFR 524.575 - Cyclosporine ophthalmic ointment.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Cyclosporine ophthalmic ointment. 524.575 Section... § 524.575 Cyclosporine ophthalmic ointment. (a) Specifications. Each gram of ointment contains 2... use—(1) Amount. Apply a 1/4-inch strip of ointment to the affected eye(s) every 12 hours. (2...

  9. 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 Section 524.1044c Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... § 524.1044c Gentamicin sulfate ophthalmic ointment. (a) Specifications. Each gram of ointment contains...

  10. Ophthalmic contributions of Raja Serfoji II (1798-1832).

    PubMed

    Biswas, Jyotirmay; Badrinath, Vasanthi; Badrinath, Sengamedu S

    2012-07-01

    To investigate and describe the ophthalmic contribution of Raja Serfoji II (1798-1832). A team of 2 ophthalmologists, director of laboratory services, one archeologist and a photographer visited Sarasvathi Mahal Library, March 2004. Photographs of ophthalmic records were taken and analysed. An interview of the present prince, S Babaji Rajah Bhonsle was taken. Ophthalmologic case sheets of 44 patients, 18 pictures were found. Forty-four patient's ophthalmic records were found. Six records were written in Modi script, 38 were written in English and 18 drawings were found. In Thanjavur, King Serfoji II carried out methodical ophthalmic practices between 1798 and 1832. Both European and Indian medicines were used. Cataract Surgery was performed. Detailed ophthalmic records were maintained. The only evidence of Serfoji's amazing contribution to medicine lies in 50 charts and manuscripts.

  11. Ophthalmic contributions of Raja Serfoji II (1798–1832)

    PubMed Central

    Biswas, Jyotirmay; Badrinath, Vasanthi; Badrinath, Sengamedu S

    2012-01-01

    Purpose: To investigate and describe the ophthalmic contribution of Raja Serfoji II (1798-1832). Materials and Method: A team of 2 ophthalmologists, director of laboratory services, one archeologist and a photographer visited Sarasvathi Mahal Library, March 2004. Photographs of ophthalmic records were taken and analysed. An interview of the present prince, S Babaji Rajah Bhonsle was taken. Ophthalmologic case sheets of 44 patients, 18 pictures were found. Results: Forty-four patient's ophthalmic records were found. Six records were written in Modi script, 38 were written in English and 18 drawings were found. Conclusion: In Thanjavur, King Serfoji II carried out methodical ophthalmic practices between 1798 and 1832. Both European and Indian medicines were used. Cataract Surgery was performed. Detailed ophthalmic records were maintained. The only evidence of Serfoji's amazing contribution to medicine lies in 50 charts and manuscripts. PMID:22824599

  12. Determining variability of ophthalmic arterial Doppler signals using Lyapunov exponents.

    PubMed

    Ubeyli, Elif Derya; Güler, Inan

    2005-06-01

    The new method presented in this study was directly based on the consideration that ophthalmic arterial Doppler signals are chaotic signals. This consideration was tested successfully using the nonlinear dynamics tools, like the computation of Lyapunov exponents. Multilayer perceptron neural network (MLPNN) architecture was formulated and used as a basis for determining variabilities such as stenosis, ocular Behcet disease, and uveitis disease in the physical state of ophthalmic arterial Doppler signals. The computed Lyapunov exponents of the ophthalmic arterial Doppler signals were used as inputs of the MLPNN. Receiver operating characteristic (ROC) curve was used to assess the performance of the detection process. The ophthalmic arterial Doppler signals were classified with the accuracy varying from 93.75% to 97.06%. The results confirmed that the proposed MLPNN trained with Levenberg-Marquardt algorithm has potential in detecting stenosis, Behcet disease and uveitis disease in ophthalmic arteries.

  13. Programmable diffractive lens for ophthalmic application

    NASA Astrophysics Data System (ADS)

    Millán, María S.; Pérez-Cabré, Elisabet; Romero, Lenny A.; Ramírez, Natalia

    2014-06-01

    Pixelated liquid crystal displays have been widely used as spatial light modulators to implement programmable diffractive optical elements, particularly diffractive lenses. Many different applications of such components have been developed in information optics and optical processors that take advantage of their properties of great flexibility, easy and fast refreshment, and multiplexing capability in comparison with equivalent conventional refractive lenses. We explore the application of programmable diffractive lenses displayed on the pixelated screen of a liquid crystal on silicon spatial light modulator to ophthalmic optics. In particular, we consider the use of programmable diffractive lenses for the visual compensation of refractive errors (myopia, hypermetropia, astigmatism) and presbyopia. The principles of compensation are described and sketched using geometrical optics and paraxial ray tracing. For the proof of concept, a series of experiments with artificial eye in optical bench are conducted. We analyze the compensation precision in terms of optical power and compare the results with those obtained by means of conventional ophthalmic lenses. Practical considerations oriented to feasible applications are provided.

  14. Nanoparticle motivated gene delivery for ophthalmic application

    PubMed Central

    Mitra, Rajendra Narayan; Zheng, Min; Han, Zongchao

    2015-01-01

    Ophthalmic gene therapy is an intellectual and intentional manipulation of desired gene expression into the specific cells of an eye for the treatment of ophthalmic (ocular) genetic dystrophies and pathological conditions. Exogenous nucleic acids such as DNA, small interfering RNA (siRNA), micro RNA (miRNA), etc., are used for the purpose of managing expression of the desired therapeutic proteins in ocular tissues. The delivery of unprotected nucleic acids into the cells is limited due to exogenous and endogenous degradation modalities. Nanotechnology, a promising and sophisticated cutting edge tool, works as a protective shelter for these therapeutic nucleic acids. They are able to be safely delivered to the required cells in order to modulate anticipated protein expression. To this end, nanotechnology is seen as a potential and promising strategy in the field of ocular gene delivery. This review focused on current nanotechnology modalities and other promising non-viral strategies being used to deliver therapeutic genes in order to treat various devastating ocular diseases. PMID:26109528

  15. Nimodipine Ophthalmic Formulations for Management of Glaucoma.

    PubMed

    Maria, Doaa Nabih; Abd-Elgawad, Abd-Elgawad Helmy; Soliman, Osama Abd-Elazeem; El-Dahan, Marwa Salah; Jablonski, Monica M

    2017-04-01

    Preparation and evaluation of topical ophthalmic formulations containing nimodipine-CD complexes prepared using HP-β-CD, SBE-β-CD and M-β-CD for the management of glaucoma. Nimodipine-CD complexes were prepared using a freeze-drying method. Two different molar ratios (NMD:CD) were used for each cyclodextrin. The inclusion complexes were characterized using DSC, FTIR, yield (%), drug content and in vitro release characteristics. NMD-CD complexes incorporated into chitosan eye drops and a temperature-triggered in situ gelling system were evaluated for their pH, viscosity and in vitro release characteristics. We determined the intraocular pressure (IOP) lowering effect of NMD-hydroxypropylmethylcellulose (HPMC) eye drops through a single dose response design using C57BL/6J mice. The minimum effective concentration (MEC) of nimodipine was further applied to mice that vary in the parental allele of Cacna1s, the drug target of nimodipine. Cytotoxicity was also evaluated. Our ophthalmic formulations possessed pH and viscosity values that are compatible with the eye. In vitro release of nimodipine was significantly increased from chitosan eye drops containing NMD-CD complexes compared to uncomplexed drug. Administration of nimodipine can lower IOP significantly after a single drop of drug HPMC suspension. The IOP-lowering response of the MEC (0.6%) was significantly influenced by the parental allele of Cacna1s. Nimodipine can be used as a promising topical drug for management of glaucoma through ocular delivery.

  16. Occult glove perforation during ophthalmic surgery.

    PubMed Central

    Apt, L; Miller, K M

    1992-01-01

    We examined the latex surgical gloves used by 56 primary surgeons in 454 ophthalmic surgical procedures performed over a 7-month period. Of five techniques used to detect pinholes, air inflation with water submersion and compression was found to be the most sensitive, yielding a 6.80% prevalence in control glove pairs and a 21.8% prevalence in postoperative study glove pairs, for a 15.0% incidence of surgically induced perforations (P = 0.000459). The lowest postoperative perforation rate was 11.4% for cataract and intraocular lens surgery, and the highest was 41.7% for oculoplastic procedures. Factors that correlated significantly with the presence of glove perforations as determined by multiple logistic regression analysis were oculoplastic and pediatric ophthalmology and strabismus surgical procedures, surgeon's status as a fellow in training, operating time, and glove size. The thumb and index finger of the nondominant hand contained the largest numbers of pinholes. These data suggest strategies for reducing the risk of cross-infection during ophthalmic surgery. PMID:1494836

  17. [Lacrimal and salivatory glycoproteins in ophthalmic herpes].

    PubMed

    Reuk, S E; Terekhina, N A

    2016-01-01

    to compare tear, saliva, and plasma levels of acute phase proteins (APPs) of inflammation in patients with herpes keratitis and to use the RESULTS in treatment evaluation. APPs were measured in tears, oral fluid, and blood plasma from 22 adults and 34 children with ophthalmic herpes as well as 68 healthy controls using immunoturbidimetric and spectrophotometric methods of detection. High levels of C-reactive protein and orosomucoid, low levels of ceruloplasmin, α1-antitrypsin, and transferrin in tears from patients with herpes keratitis as well as abnormal tear, saliva, and plasma APPs levels at discharge are poor prognostic signs. They all indicate that corneal inflammation is still intense and that the treatment should not be ceased yet. Severity of APPs concentration changes in tear from patients with herpes keratitis correlates with the depth of corneal lesions, recurrence rate, and disease dynamics. Quantitative determination of acute phase proteins in tear and oral fluid is an early and sensitive inflammation test and may be also used for non-invasive monitoring and antiviral treatment evaluation. Oral fluid allows to extend the capabilities of non-invasive diagnostics of ophthalmic herpes.

  18. Pulsed UV laser technologies for ophthalmic surgery

    NASA Astrophysics Data System (ADS)

    Razhev, A. M.; Chernykh, V. V.; Bagayev, S. N.; Churkin, D. S.; Kargapol’tsev, E. S.; Iskakov, I. A.; Ermakova, O. V.

    2017-01-01

    The paper provides an overview of the results of multiyear joint researches of team of collaborators of Institute of Laser Physics SB RAS together with NF IRTC “Eye Microsurgery” for the period from 1988 to the present, in which were first proposed and experimentally realized laser medical technologies for correction of refractive errors of known today as LASIK, the treatment of ophthalmic herpes and open-angle glaucoma. It is proposed to carry out operations for the correction of refractive errors the use of UV excimer KrCl laser with a wavelength of 222 nm. The same laser emission is the most suitable for the treatment of ophthalmic herpes, because it has a high clinical effect, combined with many years of absence of recrudescence. A minimally invasive technique of glaucoma operations using excimer XeCl laser (λ=308 nm) is developed. Its wavelength allows perform all stages of glaucoma operations, while the laser head itself has high stability and lifetime, will significantly reduce operating costs, compared with other types of lasers.

  19. National Strategies of Ophthalmic Education in Iran

    PubMed Central

    Entezari, A; Javadi, MA; Einollahi, B

    2012-01-01

    Background: Academic medicine is in a state of dramatic transformation. For this reason strategic thinking is the most essential part of educational planning. The main purpose of the present study was developing the strategic educational planning of Ophthalmology in Iran from 2007 to 2010 Methods: A qualitative investigation using focus group discussion has been implemented successfully for developing educational planning. Six to twelve representatives of key stakeholders in the ophthalmic education of Iran participated to this study. Results: Strengths, weaknesses, opportunities and threats of ophthalmology education in Iran were analyzed. Strategic goals in education, research, and health service providing domains were being developed. Educational goals were defined as training of human resources in accordance with the community needs at the level of general practitioner, specialist, and fellowships in ophthalmology. Research goals of the program were defined as scientific inter-departmental and international communications, in order to promote the level of education, research, and treatment in the country. Also, in the field of health services according to the community needs, providing services by the means of advanced and cost effective methods were defined as strategic objectives. Conclusion: Based on this strategic plan in the last three years ophthalmic education in Iran shall be many changes in educational, research and health care provision for social accountability. PMID:23113125

  20. 21 CFR 524.1200b - Kanamycin ophthalmic solution.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... chapter. (c) Conditions of use in dogs—(1) Amount. Instill a few drops into the affected eye every 3 hours... 48 hours after the eye appears normal. (2) Indications for use. For the treatment of various...

  1. Olopatadine hydrochloride ophthalmic solution for the treatment of allergic conjunctivitis.

    PubMed

    Gonzalez-Estrada, Alexei; Reddy, Keerthi; Dimov, Ves; Eidelman, Frank

    2017-08-01

    Olopatadine hydrochloride is an antihistamine and mast cell stabilizer available as oral, intranasal and ocular preparations. Most of the practical applications of olopatadine therapy focus on the treatment of allergic rhinoconjunctivitis via intranasal and ocular routes. Areas covered: This article was created from a comprehensive literature search with information taken from meta-analyses, systematic reviews, and clinical trials of children and adults. The articles that have been selected, evaluate the use of intranasal and ocular antihistamines and their role in allergic rhinoconjunctivitis. Expert opinion: Olopatadine is significantly more effective than placebos in relieving the symptoms of allergic rhinoconjunctivitis. It can function both as a viable alternative or addition to first line therapies such as intranasal steroids and oral antihistamines.

  2. 21 CFR 524.390b - Chloramphenicol ophthalmic solution.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... first 2 days. (2) Indications for use. Treatment of bacterial conjunctivitis caused by organisms 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...

  3. 21 CFR 524.1044a - Gentamicin ophthalmic solution.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... in § 510.600(c) of this chapter. (c) Conditions of use. (1) The drug is used in dogs and cats for the... drops into the conjunctival sac 2 to 4 times a day. (3) Federal law restricts this drug to use by or...

  4. 21 CFR 886.1430 - Ophthalmic contact lens radius measuring device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic contact lens radius measuring device... SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1430 Ophthalmic contact lens radius measuring device. (a) Identification. An ophthalmic contact lens radius measuring device...

  5. 21 CFR 886.1430 - Ophthalmic contact lens radius measuring device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ophthalmic contact lens radius measuring device... SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1430 Ophthalmic contact lens radius measuring device. (a) Identification. An ophthalmic contact lens radius measuring device...

  6. 21 CFR 886.1430 - Ophthalmic contact lens radius measuring device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic contact lens radius measuring device... SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1430 Ophthalmic contact lens radius measuring device. (a) Identification. An ophthalmic contact lens radius measuring device...

  7. 21 CFR 886.1430 - Ophthalmic contact lens radius measuring device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ophthalmic contact lens radius measuring device... SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1430 Ophthalmic contact lens radius measuring device. (a) Identification. An ophthalmic contact lens radius measuring device...

  8. Cytotoxicity of cannulas for ophthalmic surgery after cleaning and sterilization: evaluation of the use of enzymatic detergent to remove residual ophthalmic viscosurgical device material.

    PubMed

    Tamashiro, Natacha S M; Souza, Rafael Q; Gonçalves, Cláudia R; Ikeda, Tamiko I; Luz, Reginaldo A; Cruz, Aurea S; Padoveze, Maria C; Graziano, Kazuko U

    2013-06-01

    To evaluate the cytotoxicity of reusable cannulas for ophthalmic surgery after the cannulas were filled with an ophthalmic viscosurgical device (OVD) and cleaned with an enzymatic detergent. Microbiological Testing Laboratory, Department of Medical-Surgical Nursing, University of São Paulo School of Nursing, and Cell Culture Section, Adolfo Lutz Institute, São Paulo, Brazil. Experimental study. The sample consisted of 30 reusable 25-gauge injection cannulas, 20.0 mm in length, whose lumens were filled with an OVD solution for 50 minutes. The following steps were used to process the cannulas: (1) presoaking, (2) washing the lumen using a high-pressure water jet, (3) backwashing with enzymatic detergent in ultrasonic cleaner, (4) preliminary rinsing with tap water, (5) final rinsing with sterile distilled water, (6) drying with compressed filtered air, (7) wrapping in surgical-grade paper, and (8) steam sterilization at 134°C for 4 minutes. The cannulas were then tested for cytotoxicity according to the United States Pharmacopeia 32. The cleaning protocol used in this study removed residues of OVD solution and enzymatic detergent as shown by the lack of cytotoxicity of all sample extracts. This cleaning protocol has the potential to minimize the occurrence of toxic anterior segment syndrome associated with residues of OVD solutions and enzymatic detergents. No author has a financial or proprietary interest in any material or method mentioned. Copyright © 2013 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

  9. Molecular Solutions to Low Vision Resulting from Battlefield Injuries. Addendum

    DTIC Science & Technology

    2010-02-01

    uveitis OS 2 weeks following uncomplicated LASIK. The subject was treated with Prednisolone Acetate 1.0% ophthalmic suspension q2hrs and cyclopentolate 1...ophthalmic solution TID, which resolved the uveitis . The PI felt this was unrelated to the 3 surgery or the study participation. This was

  10. Molecular Solutions to Low Vision Resulting from Battlefield Injuries

    DTIC Science & Technology

    2011-02-01

    experienced acute, non-granulomatous anterior uveitis OS 2 weeks following uncomplicated LASIK. The subject was treated with Prednisolone Acetate 1.0...ophthalmic suspension q2hrs and cyclopentolate 1% ophthalmic solution TID, which resolved the uveitis . The PI felt this was unrelated to the

  11. Molecular Solutions to Low Vision Resulting from Battlefield Injuries. Addendum

    DTIC Science & Technology

    2009-05-01

    granulomatous anterior uveitis OS 2 weeks following uncomplicated LASIK. The subject was treated with Prednisolone Acetate 1.0% ophthalmic suspension...q2hrs and cyclopentolate 1% ophthalmic solution TID, which resolved the uveitis . The PI felt this was unrelated to the surgery or the study

  12. Ophthalmic fluorometholone-gentamicin versus ophthalmic betamethasone-gentamicin following cataract surgery.

    PubMed

    Steinbach, P D; Bauer, J; Sunder Raj, P

    1997-03-01

    A prospective, randomised, investigator-masked, parallel-group study was performed to compare fluorometholone-gentamicin eye drops and ointment with betamethasone-gentamicin eyedrops and ointment in the control of ocular inflammation after cataract surgery. Seventy patients (35 in each treatment group) of both sexes undergoing cataract-lens implant surgery for visually disabling cataract were enrolled in the study. The demographic and baseline parameters on day I, the day after surgery, were similar in the two study groups. After treatment, on day 3 and day 6 post-operatively, the reduction in cells in the anterior chamber and conjunctival hyperaemia were similar in the two study groups. Both treatments were equally well-tolerated. Ophthalmic fluorometholone-gentamicin was as effective as ophthalmic betamethasone-gentamicin in the control of ocular inflammation after cataract surgery.

  13. Simple HPLC determination of benzalkonium chloride in ophthalmic formulations containing antazoline and tetrahydrozoline.

    PubMed

    Rojsitthisak, Pornchai; Wichitnithad, Wisut; Pipitharome, Ongart; Sanphanya, Kingkan; Thanawattanawanich, Peeracha

    2005-01-01

    A simple and rapid analytical procedure for routine quantification of n-C12H25 and n-C14H29 benzalkonium chloride (C-12 and C-14 BKC) homologs in ophthalmic formulations containing antazoline HCl and tetrahydrozoline HCl by high-performance liquid chromatography was developed and validated. The ophthalmic solution samples can be directly analyzed by reversed-phase on HiQ-Sil C18 column (4.6 mm x 150 mm, i.d., 5-microm particle size) with acetonitrile-sodium acetate buffer (pH 5.0; 0.2 M) (70:30, v/v) as mobile phase. UV Detection was carried out at 262 nm. The method was linear over the selected concentration and ranged from 0.03 to 0.10 mg/ml (r2 = 0.9999) and from 0.01 to 0.05 mg/ml (r2 = 0.9979) for C-12 and C-14 BKC homologs, respectively. The mean percent recoveries were 100.2 and 102.6 and the percent CV values were 1.3 and 3.5 for C-12 and C-14 BKC homologs, respectively. The results demonstrated the good linearity, accuracy, and precision. The method was applied to determine two commercial ophthalmic formulations, and the percent label amounts of total BKC contents were found to be 99.7 and 103.2.

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

    PubMed

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

    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.

  15. 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

  16. 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.

  17. [Oclusion of upper ophthalmic vein--a case report].

    PubMed

    Kácerik, M; Alexík, M; Lipková, B

    2009-07-01

    Thrombosis of upper ophthalmic vein is both rare and serious pathologic event. Authors present a case of isolated unilateral upper ophthalmic vein thrombosis in 76-year-old woman, who despite treatment ended with amaurosis and secondary neovascular glaucoma. In differential diagnosis authors focused on searching for inflammatory process of orbit with adjacent structures as well as local and general causes leading to venous thrombosis. None of these were proven; it was a rare case of a patient with isolated upper ophthalmic vein thrombosis.

  18. Neuro-Ophthalmic Syndromes and Processing Speed in Multiple Sclerosis.

    PubMed

    Costa, Silvana L; Gonçalves, Óscar F; Chiaravalloti, Nancy D; DeLuca, John; Almeida, Jorge

    2016-03-01

    The impact of prior neuro-ophthalmic syndromes on the performance on vision-based neuropsychological tasks in patients with multiple sclerosis (MS) is unknown. Two groups of MS participants, one with (Msos+) and the other without (Msos-), a history of neuro-ophthalmic syndromes, underwent neuropsychological assessment and were compared with healthy age- and education-matched controls (HC). Participants with Msos+ performed significantly worse on the symbol digit modalities test than the Msos- (P < 0.03) and the HC groups (P < 0.01) and coding (P < 0.01). A clinical history of neuro-ophthalmic syndromes is associated with reduced performance on visual processing speed tasks.

  19. Numerical Modeling of Ophthalmic Response to Space

    NASA Technical Reports Server (NTRS)

    Nelson, E. S.; Myers, J. G.; Mulugeta, L.; Vera, J.; Raykin, J.; Feola, A.; Gleason, R.; Samuels, B.; Ethier, C. R.

    2015-01-01

    To investigate ophthalmic changes in spaceflight, we would like to predict the impact of blood dysregulation and elevated intracranial pressure (ICP) on Intraocular Pressure (IOP). Unlike other physiological systems, there are very few lumped parameter models of the eye. The eye model described here is novel in its inclusion of the human choroid and retrobulbar subarachnoid space (rSAS), which are key elements in investigating the impact of increased ICP and ocular blood volume. Some ingenuity was required in modeling the blood and rSAS compartments due to the lack of quantitative data on essential hydrodynamic quantities, such as net choroidal volume and blood flowrate, inlet and exit pressures, and material properties, such as compliances between compartments.

  20. Coherent methods for measuring ophthalmic surfaces

    NASA Astrophysics Data System (ADS)

    Rottenkolber, Matthias; Podbielska, Halina

    1996-01-01

    Topographic analysis of the ophthalmic surfaces is an important task. Especially recently, when a laser assisted refractive surgery becomes more and more popular in a daily clinical praxis. Ophthalmologists need to know exact corneal parameters as a basis for proper operational approach, as well as for monitoring of the post-operative process. The fitting of the contact lenses can be more accurate when topography of both, cornea and contacts, can be precisely measured. We develop new coherent methods for measuring of the topography of curved optical surfaces. One of the proposed techniques is based on interferometry with a special distance measurement unit and spatial phase shifting interferogram evaluation. The other one uses deflectometry with spatial carrier frequency. The sensitivity of this method is adjustable and thus it closes the gap between the white light and interferometric measuring methods. The techniques proposed here can be suitable for measurement of the contact lenses or corneal surface.

  1. M-sequences in ophthalmic electrophysiology.

    PubMed

    Müller, Philipp L; Meigen, Thomas

    2016-01-01

    The aim of this review is to use the multimedia aspects of a purely digital online publication to explain and illustrate the highly capable technique of m-sequences in multifocal ophthalmic electrophysiology. M-sequences have been successfully applied in clinical routines during the past 20 years. However, the underlying mathematical rationale is often daunting. These mathematical properties of m-sequences allow one not only to separate the responses from different fields but also to analyze adaptational effects and impacts of former events. By explaining the history, the formation, and the different aspects of application, a better comprehension of the technique is intended. With this review we aim to clarify the opportunities of m-sequences in order to motivate scientists to use m-sequences in their future research.

  2. An historical ophthalmic study of Jane Austen.

    PubMed

    Wilson, Graham A

    2012-11-01

    Today, no other classic novelist has the popularity or power of Jane Austen, and in 2013 the world will celebrate 200 years of her comic masterpiece Pride and Prejudice. Her millions of fans have an abiding fascination with all aspects of her life, including her health and the cause of her death. This historical ophthalmic study of Jane Austen, based on very incomplete medical bibliographic data, finds that she had a mild ocular surface disorder from age 23. This disorder did not significantly impact on her visual performance for writing. There are many references to eyes in her novels, but Jane's eyes and those of her characters cannot contribute further to the debate around the cause of her death at age 41.

  3. Ophthalmic microsurgical robot and surgical simulator

    NASA Astrophysics Data System (ADS)

    Hunter, Ian W.; Jones, Lynette; Doukoglou, Tilemachos; Lafontaine, Serge; Hunter, Peter J.; Sagar, Mark

    1995-12-01

    A teleoperated microsurgical robot has been developed together with a virtual environment for microsurgery on the eye. Visual and mechanical information is relayed via bidirectional pathways between the slave and master of the microsurgical robot. The system permits surgeons to operate in one of three alternative modes: on real tissue, on physically simulated tissue in a mannequin, or on a computer based physical model contained within the ophthalmic virtual environment. In all three modalities, forces generated during tissue manipulation (i.e. resecting, probing) are fed back to the surgeon via a force reflecting interface to give the haptic sensations (i.e. `feel') appropriate to the actions being performed. The microsurgical robot has been designed so that the master and slave systems can be in physically separate environments which permits remote surgery to be performed. The system attempts to create an immersive environment for the operator by including not only visual and haptic feedback, but also auditory, cutaneous, and, ultimately, olfactory sensations.

  4. A Biorepository for Ophthalmic Surgical Specimens

    PubMed Central

    Skeie, Jessica M.; Tsang, Stephen H.; Zande, Ryan Vande; Fickbohm, Macy M.; Shah, Shaival S.; Vallone, John G.; Mahajan, Vinit B.

    2014-01-01

    Biorepositories are collections of surgically obtained human tissues for current and future investigations of disease mechanisms, therapeutics, and diagnostics. In ophthalmology, a critical challenge is how to interface the operating room with the laboratory. To attain standards required for basic research, clinical and research teams must cooperate to collect, annotate, and store specimens that yield consistent results required for advanced molecular techniques. We developed an efficient platform for obtaining vitreous and other eye tissues from the operating room and transferring them to the lab. The platform includes a mobile lab cart for on-site tissue processing, a multi-user, web-based database for point-of-care phenotypic capture, and an integrated data tracking system for long-term storage. These biorepository instruments have proven essential for our studies in ophthalmic disease proteomics. This system can be implemented in other operating rooms and laboratories for a variety of biological tissues. PMID:24115637

  5. Seed-less iodine-125 ophthalmic applicator.

    PubMed

    Puchalska, Izabela; Mielcarski, Mieczyslaw

    2003-01-01

    A method of preparation a seed-less active insert of iodine-125 ophthalmic applicator is described. Internal electrolysis was applied for fixing iodine-125 on the concave surface of the silver shell which is afterwards hermetically sealed inside a spherically shaped acrylic insert. The current-voltage characteristics of the galvanic cell used for deposition of silver iodide were determined. The results of the measurements of the energy spectra of the radiation emitted by a seed-less and seed-containing applicator are presented. The iodine-125 surface distribution uniformity on a silver shell was measured. The depth dose rate measurements indicate that the total activity incorporated in a seed-less applicator can be lower than that in seed-containing, while simultaneously assuring the desired dose rate. Copyright 2002 Elsevier Science Ltd.

  6. 21 CFR 524.575 - Cyclosporine ophthalmic ointment.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS... keratoconjunctivitis sicca (KCS) and chronic superficial keratitis (CSK) in dogs. (3) Limitations. Federal law...

  7. 21 CFR 524.575 - Cyclosporine ophthalmic ointment.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS... keratitis (CSK) in dogs. (3) Limitations. Place ointment directly on cornea or into the conjunctival sac...

  8. 21 CFR 524.390 - Chloramphenicol ophthalmic ointment.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS... in dogs and cats—(1) Amount. Apply every 3 hours around the clock for 48 hours, after which night...

  9. 21 CFR 524.390 - Chloramphenicol ophthalmic ointment.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS... in dogs and cats—(1) Amount. Apply every 3 hours around the clock for 48 hours, after which night...

  10. 21 CFR 524.1044c - Gentamicin sulfate ophthalmic ointment.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS... § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats—(1) Amount. Apply approximately a 1...

  11. 21 CFR 524.1044c - Gentamicin sulfate ophthalmic ointment.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS... § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats—(1) Amount. Apply approximately a 1...

  12. 21 CFR 524.575 - Cyclosporine ophthalmic ointment.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS... keratitis (CSK) in dogs. (3) Limitations. Place ointment directly on cornea or into the conjunctival sac...

  13. 21 CFR 524.1044c - Gentamicin sulfate ophthalmic ointment.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS... § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats—(1) Amount. Apply approximately a 1...

  14. 21 CFR 524.1044c - Gentamicin ophthalmic ointment.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS... § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats—(1) Amount. Apply approximately a 1...

  15. 21 CFR 200.50 - Ophthalmic preparations and dispensers.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... preparations offered or intended for ophthalmic use that are not sterile may be regarded as adulterated within... be deemed misbranded within the meaning of section 502(j) of the act. This ruling is extended...

  16. 21 CFR 886.1665 - Ophthalmic rotary prism.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Identification. An ophthalmic rotary prism is a device with various prismatic powers intended to be handheld and... also exempt from the current good manufacturing practice requirements of the quality system regulation...

  17. Selected diagnostic ophthalmic tests in the red kangaroo (Macropus rufus).

    PubMed

    Takle, Ginger L; Suedmeyer, W Kirk; Hunkeler, Amy

    2010-06-01

    The following tests were performed on a total of 20 eyes: Schirmer tear test, intraocular pressure (IOP), assessment of conjunctival flora, and pupillary diameter with application of topical tropicamide in 10 healthy captive red kangaroos (Macropus rufus) under manual restraint. The mean Schirmer tear test value was 22.6 +/- 6.07 mm/min. The mean intraocular pressure was 17.45 +/- 7.23 mm Hg. Values did not differ between eyes or gender for either test, but significant differences were identified for IOP values according to age. The most common bacteria isolated from the conjunctival fornix were Staphylococcus epidermidis (54.5%) and Corynebacterium sp. (18.2%). The mean onset of mydriasis after instillation of 1% tropicamide ophthalmic solution was 16.7 +/- 3.34 min and the mean duration of effect was 17.6 +/- 8.26 hr. The data obtained in this investigation will aid veterinary ophthalmologists and zoo veterinarians to diagnose ocular diseases in the red kangaroo accurately.

  18. Exploring Leptin Antagonism in Ophthalmic Cell Models

    PubMed Central

    Coroniti, Roberta; Otvos, Laszlo; Surmacz, Eva

    2013-01-01

    Background Emerging evidence suggests that angiogenic and pro-inflammatory cytokine leptin might be implicated in ocular neovascularization. However, the potential of inhibiting leptin function in ophthalmic cells has never been explored. Here we assessed mitogenic, angiogenic, and signaling leptin activities in retinal and corneal endothelial cells and examined the capability of a specific leptin receptor (ObR) antagonist, Allo-aca, to inhibit these functions. Methods and Results The experiments were carried out in monkey retinal (RF/6A) and bovine corneal (BCE) endothelial cells. Leptin at 50-250 ng/mL stimulated the growth of both cell lines in a dose-dependent manner. The maximal mitogenic response (35±7 and 27±3% in RF6A and BCE cells, respectively) was noted at 24 h of 250 ng/mL leptin treatments. Leptin-dependent proliferation was reduced to base levels with 10 and 100 nM Allo-aca in BCE and RF6A cells, respectively. In both cell lines, leptin promoted angiogenic responses, with the maximal increase in tube formation (163±10 and 133±8% in RF6A and BCE cultures, respectively) observed under a 250 ng/mL leptin treatment for 3 h. Furthermore, in both cell lines 250 ng/mL leptin modulated the activity or expression of several signaling molecules involved in proliferation, inflammatory activity and angiogenesis, such as STAT3, Akt, and ERK1/2, COX2, and NFκB. In both cell lines, leptin-induced angiogenic and signaling responses were significantly inhibited with 100 nM Allo-aca. We also found that leptin increased its own mRNA and protein expression in both cell lines, and this autocrine effect was abolished by 100-250 nM Allo-aca. Conclusions Our data provide new insights into the role of leptin in ocular endothelial cells and represent the first original report on targeting ObR in ophthalmic cell models. PMID:24098500

  19. New eye phantom for ophthalmic surgery

    NASA Astrophysics Data System (ADS)

    Fogli, Gessica; Orsi, Gianni; De Maria, Carmelo; Montemurro, Francesca; Palla, Michele; Rizzo, Stanislao; Vozzi, Giovanni

    2014-06-01

    In this work, we designed and realized a new phantom able to mimic the principal mechanical, rheological, and physical cues of the human eye and that can be used as a common benchmark to validate new surgical procedures, innovative vitrectomes, and as a training system for surgeons. This phantom, in particular its synthetic humor vitreous, had the aim of reproducing diffusion properties of the natural eye and can be used as a system to evaluate the pharmacokinetics of drugs and optimization of their dose, limiting animal experiments. The eye phantom was built layer-by-layer starting from the sclera up to the retina, using low cost and easy to process polymers. The validation of the phantom was carried out by mechanical characterization of each layer, by diffusion test with commercial drugs into a purposely developed apparatus, and finally by a team of ophthalmic surgeons. Experiments demonstrated that polycaprolactone, polydimethylsiloxane, and gelatin, properly prepared, are the best materials to mimic the mechanical properties of sclera, choroid, and retina, respectively. A polyvinyl alcohol-gelatin polymeric system is the best for mimicking the viscosity of the human humor vitreous, even if the bevacizumab half-life is lower than in the human eye.

  20. Walking simulator for evaluation of ophthalmic devices

    NASA Astrophysics Data System (ADS)

    Barabas, James; Woods, Russell L.; Peli, Eli

    2005-03-01

    Simulating mobility tasks in a virtual environment reduces risk for research subjects, and allows for improved experimental control and measurement. We are currently using a simulated shopping mall environment (where subjects walk on a treadmill in front of a large projected video display) to evaluate a number of ophthalmic devices developed at the Schepens Eye Research Institute for people with vision impairment, particularly visual field defects. We have conducted experiments to study subject's perception of "safe passing distance" when walking towards stationary obstacles. The subject's binary responses about potential collisions are analyzed by fitting a psychometric function, which gives an estimate of the subject's perceived safe passing distance, and the variability of subject responses. The system also enables simulations of visual field defects using head and eye tracking, enabling better understanding of the impact of visual field loss. Technical infrastructure for our simulated walking environment includes a custom eye and head tracking system, a gait feedback system to adjust treadmill speed, and a handheld 3-D pointing device. Images are generated by a graphics workstation, which contains a model with photographs of storefronts from an actual shopping mall, where concurrent validation experiments are being conducted.

  1. Ophthalmic microsurgical robot and associated virtual environment.

    PubMed

    Hunter, I W; Jones, L A; Sagar, M A; Lafontaine, S R; Hunter, P J

    1995-03-01

    An ophthalmic virtual environment has been developed as part of a teleoperated microsurgical robot built to perform surgery on the eye. The virtual environment is unique in that it incorporates a detailed continuum model of the anatomical structures of the eye, its mechanics and optical properties, together with a less detailed geometric-mechanical model of the face. In addition to providing a realistic visual display of the eye being operated on, the virtual environment simulates tissue properties during manipulation and cutting and the forces involved are determined by solving a mechanical finite element model of the tissue. These forces are then fed back to the operator via a force reflecting master and so the surgeon can experience both the visual and mechanical sensations associated with performing surgery. The virtual environment can be used to enhance the images produced by the camera on the microsurgical slave robot during surgery and as a surgical simulator in which it replaces these images with computer graphics generated from the eye model.

  2. Patient education preferences in ophthalmic care

    PubMed Central

    Rosdahl, Jullia A; Swamy, Lakshmi; Stinnett, Sandra; Muir, Kelly W

    2014-01-01

    Background The learning preferences of ophthalmology patients were examined. Methods Results from a voluntary survey of ophthalmology patients were analyzed for education preferences and for correlation with race, age, and ophthalmic topic. Results To learn about eye disease, patients preferred one-on-one sessions with providers as well as printed materials and websites recommended by providers. Patients currently learning from the provider were older (average age 59 years), and patients learning from the Internet (average age 49 years) and family and friends (average age 51 years) were younger. Patients interested in cataracts, glaucoma, macular degeneration, and dry eye were older; patients interested in double vision and glasses were younger. There were racial differences regarding topic preferences, with Black patients most interested in glaucoma (46%), diabetic retinopathy (31%), and cataracts (28%) and White patients most interested in cataracts (22%), glaucoma (22%), and macular degeneration (19%). Conclusion Most ophthalmology patients preferred personalized education: one-on-one with their provider or a health educator and materials (printed and electronic) recommended by their provider. Age-related topics were more popular with older patients, and diseases with racial risk factors were more popular with high risk racial groups. PMID:24812493

  3. New eye phantom for ophthalmic surgery.

    PubMed

    Fogli, Gessica; Orsi, Gianni; De Maria, Carmelo; Montemurro, Francesca; Palla, Michele; Rizzo, Stanislao; Vozzi, Giovanni

    2014-06-01

    In this work, we designed and realized a new phantom able to mimic the principal mechanical, rheological, and physical cues of the human eye and that can be used as a common benchmark to validate new surgical procedures, innovative vitrectomes, and as a training system for surgeons. This phantom, in particular its synthetic humor vitreous, had the aim of reproducing diffusion properties of the natural eye and can be used as a system to evaluate the pharmacokinetics of drugs and optimization of their dose, limiting animal experiments. The eye phantom was built layer-by-layer starting from the sclera up to the retina, using low cost and easy to process polymers. The validation of the phantom was carried out by mechanical characterization of each layer, by diffusion test with commercial drugs into a purposely developed apparatus, and finally by a team of ophthalmic surgeons. Experiments demonstrated that polycaprolactone, polydimethylsiloxane, and gelatin, properly prepared, are the best materials to mimic the mechanical properties of sclera, choroid, and retina, respectively. A polyvinyl alcohol-gelatin polymeric system is the best for mimicking the viscosity of the human humor vitreous, even if the bevacizumab half-life is lower than in the human eye.

  4. Primary ophthalmic rhabdomyosarcoma in 33 patients.

    PubMed Central

    Shields, C L; Shields, J A; Honavar, S G; Demirci, H

    2001-01-01

    PURPOSE: To review the findings, management, and outcome in 33 cases of primary ophthalmic rhabdomyosarcoma. METHODS: The records of 33 consecutive patients from a single ocular oncology center were analyzed retrospectively for outcomes of final visual acuity, local recurrence, and distant metastasis. RESULTS: Rhabdomyosarcoma was primarily located in the orbit m 25 cases (76%), conjunctiva in 4 (12%), eyelid in 1 (3%), and uveal tract in 3 (9%). Findings had been present for a mean of 5 weeks and included proptosis in 10 patients (30%), eyelid swelling in 7 (21%), and blepharoptosis in 6 (18%). The initial diagnoses before referral to us included primarily rhabdomyosarcoma in 8 cases (24%), conjunctivitis in 5 (15%), cellulitis in 5 (15%), and pseudotumor in 4 (12%). Tumors were classified according to the Intergroup Rhabdomyosarcoma Study Group staging and treatment protocols as group I in 4 cases (12%), group II in 12 (36%), group III in 16 (48%), and group IV in 1 case (3%). Treatment included surgical debulking, chemotherapy, and radiotherapy. Local tumor recurrence was detected in 6 patients (18%), lymph node spread in 2 (6%), and distant metastasis in 2 (6%). Long-term visual outcome of the 28 patients who maintained their globe was 20/20 to 20/40 in 11 patients (39%), 20/50 to 20/100 in 5 (18%), and 20/200 or worse in 12 (43%). Mean follow-up was 8.3 years; tumor-related death occurred in 1 patients (3%). CONCLUSIONS: Rhabdomyosarcoma can present in the orbit, eyelid, conjunctiva, and uveal tract. Following treatment, local tumor recurrence occurs in 18% of cases, metastasis in 6%, and death in 3%. PMID:11797301

  5. Case Report: A Troublesome Ophthalmic Artery Aneurysm

    PubMed Central

    Meling, T. R.; Sorteberg, W.; Bakke, S. J.; Jacobsen, E. A.; Lane, P.; Vajkoczy, P.

    2014-01-01

    Objective and Importance When treating large unruptured ophthalmic artery (OA) aneurysms causing progressive blindness, surgical clipping is still the preferred method because aneurysm sac decompression may relieve optic nerve compression. However, endovascular treatment of OA aneurysms has made important progress with the introduction of stents. Although this development is welcomed, it also makes the choice of treatment strategy less straightforward than in the past, with the potential of missteps. Clinical Presentation A 56-year-old woman presented with a long history of progressive unilateral visual loss and magnetic resonance imaging showing a 20-mm left-sided OA aneurysm. Intervention Because of her long history of very poor visual acuity, we considered her left eye to be irredeemable and opted for endovascular therapy. The OA aneurysms was treated with stent and coils but continued to grow, threatening the contralateral eye. Because she failed internal carotid artery (ICA) balloon test occlusion, we performed a high-flow extracranial-intracranial bypass with proximal ICA occlusion in the neck. However, aneurysm growth continued due to persistent circulation through reversed blood flow in distal ICA down to the OA and the cavernous portion of the ICA. Due to progressive loss of her right eye vision, we surgically occluded the ICA proximal to the posterior communicating artery and excised the coiled, now giant, OA aneurysm. This improved her right eye vision, but her left eye was permanently blind. Conclusion This case report illustrates complications of the endovascular and surgical treatment of a large unruptured OA aneurysm. PMID:25485220

  6. Ophthalmic features of spinocerebellar ataxia type 7.

    PubMed

    Campos-Romo, A; Graue-Hernandez, E O; Pedro-Aguilar, L; Hernandez-Camarena, J C; Rivera-De la Parra, D; Galvez, V; Diaz, R; Jimenez-Corona, A; Fernandez-Ruiz, J

    2017-08-11

    PurposeTo analyze the relation between ophthalmologic and motor changes in spinocerebellar ataxia type 7 (SCA7).Patients and methodsThis was a case series study. Sixteen SCA7 patients underwent a comprehensive ophthalmic examination, including ocular extrinsic motility testing, color vision test, and optical coherence tomography of the optic nerve and macula. Changes in the corneal endothelium, electroretinographic patterns, and a complete neurologic evaluation using the Scale for the Assessment and Rating of Ataxia (SARA) were evaluated. Correlations of endothelial cell density (ECD) with number of CAG repetitions and the SARA scores were estimated.ResultsAll patients showed various degrees of visual impairment mainly due to macular deterioration. Notably, they also presented decreased ECD. Pairwise correlations of ECD with number of CAG repeats and severity of motor symptoms quantified with the SARA scores were inverse (r=-0.46, P=0.083 and r=-0.64, P=0.009, respectively). Further analyses indicated an average ECD decrease of 48 cells/mm(2) (P=0.006) per unit of change on the number of CAG repeats, and of 75 cells/mm(2) (P=0.001) per unit of change on the SARA scores.ConclusionsThe results agree with previous ophthalmological findings regarding the widespread effect of SCA7 mutation on the patient's visual system. However, the results also show a significant negative correlation of decreased ECD with both CAG repetitions and SARA scores. This suggests that motor systems could degenerate in parallel with visual systems, although more research is needed to determine whether the degeneration is caused by the same mechanisms.Eye advance online publication, 11 August 2017; doi:10.1038/eye.2017.135.

  7. Optical coherence tomography in ophthalmic applications

    NASA Astrophysics Data System (ADS)

    Wei, Jay; Zhao, Yonghua; Kulkarni, Manish D.; Kirschbaum, Alan R.; Everett, Matthew J.; Harman, Jonathan W.; Pedersen, Per

    2003-07-01

    Image resolution, tissue penetration, and scan speed are among the most important parameters when designing an OCT system for ophthalmic use. Human retinal tissue is highly reflective in the near infrared spectrum range. A SLD at 820nm with 25nm FWHM spectral bandwidth provides 10μm coherence length in retinal tissue. Its appropriate power level, simplicity of use, high resolution, and relatively low cost, make the 820nm SLD the best choice light source for retinal OCT. A 1300nm SLD can penetrate deeper into the sclera tissue and since the 1300nm wavelength is highly absorbed in the vitreous, the ANSI laser safety standard allows higher maximum permissible power to the human eye. Higher scan speed can also be achieved. In this paper, we report two OCT systems that are designed specifically for retinal and anterior segment imaging of the human eye. Retinal OCT scans 400 A-scans per second, 2mm depth in tissue, and 10 μm image resolution with an 820nm SLD. Anterior segment OCT (AC-OCT) scans 2000 A-scans per second, 6mm depth in tissue, and 16μm image resolution with a 1300nm SLD. Benefits of suitable wavelength selection in scanning different tissue are clearly seen in the OCT images. Retinal OCT (OCT3) demonstrates significant improvement over the previous generation (OCT1/OCT2) from both a technical and cost point of view. AC-OCT performs 8 frames of 256 A-scans per second and is capable of imaging the human eye in vivo with minimum eye motion artifacts. It has potential use in refractive surgery, angle-closure glaucoma, and cataract surgery.

  8. Voriconazole Composited Polyvinyl Alcohol/Hydroxypropyl-β-Cyclodextrin Nanofibers for Ophthalmic Delivery

    PubMed Central

    Sun, Xiaoyi; Cai, Zhengyuan; Yu, Lingyan; Lv, Yuanyuan

    2016-01-01

    Voriconazole (VRC) incorporated in composited polyvinyl alcohol (PVA)/hydroxypropyl-β-cyclodextrin (HPβCD) blended nanofibers were produced via electrospinning for efficient ophthalmic delivery. The VRC loading capacity increased with increasing HPβCD content. The optimal solution for electrospinning consisted of 8% (w/v) PVA, 4% (w/v) HPβCD and 0.5% (w/v) VRC. The nanofibers exhibited bead-free average fiber diameters of 307±31 nm and VRC was released in vitro in a sustained manner. The VRC nanofibers were characterized by infrared spectroscopy (FTIR), thermogravimetric analysis (TGA), differential scanning calorimetry (DSC) and scanning electron microscopy (SEM). The proton nuclear magnetic resonance (1H-NMR) was used to analyze the molar ratio of HPβCD/VRC in the nanofibers. Compared with a VRC solution, the nanofibers significantly prolonged the half life, and increased the bioavailability of VRC in rabbit tears. No obvious signs of irritation were observed after application in the conjunctival sac. VRC nanofibers are promising for ophthalmic drug delivery and further pharmacodynamics studies are needed. PMID:27974859

  9. Voriconazole Composited Polyvinyl Alcohol/Hydroxypropyl-β-Cyclodextrin Nanofibers for Ophthalmic Delivery.

    PubMed

    Sun, Xiaoyi; Yu, Zhenwei; Cai, Zhengyuan; Yu, Lingyan; Lv, Yuanyuan

    2016-01-01

    Voriconazole (VRC) incorporated in composited polyvinyl alcohol (PVA)/hydroxypropyl-β-cyclodextrin (HPβCD) blended nanofibers were produced via electrospinning for efficient ophthalmic delivery. The VRC loading capacity increased with increasing HPβCD content. The optimal solution for electrospinning consisted of 8% (w/v) PVA, 4% (w/v) HPβCD and 0.5% (w/v) VRC. The nanofibers exhibited bead-free average fiber diameters of 307±31 nm and VRC was released in vitro in a sustained manner. The VRC nanofibers were characterized by infrared spectroscopy (FTIR), thermogravimetric analysis (TGA), differential scanning calorimetry (DSC) and scanning electron microscopy (SEM). The proton nuclear magnetic resonance (1H-NMR) was used to analyze the molar ratio of HPβCD/VRC in the nanofibers. Compared with a VRC solution, the nanofibers significantly prolonged the half life, and increased the bioavailability of VRC in rabbit tears. No obvious signs of irritation were observed after application in the conjunctival sac. VRC nanofibers are promising for ophthalmic drug delivery and further pharmacodynamics studies are needed.

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

    PubMed Central

    Marlowe, Zora T; Davio, Stephen R

    2014-01-01

    Introduction 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. Methods 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. Results 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

  11. Preparation and evaluation of nanoparticles loaded ophthalmic in situ gel.

    PubMed

    Kesarla, Rajesh; Tank, Tanvi; Vora, Pratik Ashwinbhai; Shah, Tanvi; Parmar, Sagar; Omri, Abdelwahab

    2016-09-01

    Conventional ophthalmic solutions often eliminate rapidly after administration and cannot provide and maintain an adequate concentration of drug in the pre-corneal area. Above problem can be overcome by the use of in situ gel forming systems that are instilled as drops in to the eye and undergo a sol-gel transition in the cul-de-sac. An ion sensitive polymer gellan gum was used as gelling agent which formed immediate gel and remained for extended time period. Nanoparticles of moxifloxacin, prepared by solvent evaporation, were separated by freeze drying. The rheological properties and in vitro drug release test of in situ gel loaded with nanoparticles were evaluated and compared with marketed preparation. In vitro release study demonstrated diffusion controlled release for moxifloxacin from formulations over a period of 12 h. The developed formulation was stable and showed enhanced contact time minimizing the frequency of administration. Confocal microscopy showed clear permeation of drug loaded nanoparticles across L/S of cornea. The formulation of moxifloxacin was found liquid at the formulated pH and formed gel in the presence of mono or divalent cations. The gel formed in situ showed sustained drug release over a period of 10-12 h. The formulations were less viscous before instillation and formed strong gel after instilling it into cul-de-sac. It is thus concluded that by adopting a systematic formulation approach, an optimum point can be reached in the shortest time with minimum efforts to achieve desirable rheological and in vitro release property for in situ gel forming system.

  12. 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.

  13. Patients presenting to an Ophthalmic Emergency Department after 5pm.

    PubMed

    Prendiville, C; Nasser, Q J; McGettrick, P

    2008-04-01

    We analysed the attendance after 5pm at the Ophthalmic Accident and Emergency department of Royal Victoria Eye and Ear Hospital, Dublin over a period of 34 days. 345 patients attended, 203 (73%) were considered non urgent by the duty ophthalmologist. 12 (3.4%) required immediate admission. 245 (71%) self referred without an accompanying letter. There is a disproportionate amount of non emergency presentations to the RVEEH ophthalmic emergency department that leads to long waiting times and inefficient use of resources. By implementing a multifaceted educational and publicity programme and by improving access to daytime ophthalmic services we will eliminate the need for patients to attend our A&E with non-acute complaints after 5 pm. A new Accident and Emergency department policy is required to prevent inappropriate use of the service after 5 pm.

  14. 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.

  15. 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

  16. 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.

  17. Ophthalmic presentation of giant cell arteritis in African-Americans.

    PubMed

    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

    PurposeTo determine the differences in the presentation of ophthalmic giant cell arteritis between African-Americans and Caucasians.MethodsThis 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.ResultsThe 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).ConclusionsThe 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.

  18. 21 CFR 524.390 - Chloramphenicol 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 Chloramphenicol ophthalmic and topical dosage... HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS § 524.390 Chloramphenicol ophthalmic and topical dosage forms....

  19. 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... times for ophthalmic treatments. The decay must be based on the activity determined under § 35.432. (b...

  20. 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... times for ophthalmic treatments. The decay must be based on the activity determined under § 35.432. (b...

  1. Novel NSAIDs ophthalmic formulation: flurbiprofen axetil emulsion with low irritancy and improved anti-inflammation effect.

    PubMed

    Shen, Jinqiu; Gan, Li; Zhu, Chunliu; Zhang, Xinxin; Dong, Yang; Jiang, Min; Zhu, Jiabi; Gan, Yong

    2011-06-30

    The aim of this study was to design and formulate a novel low-irritant NSAIDs ophthalmic emulsion of flurbiprofen axetil (FBA), the prodrug of flurbiprofen (FB). FBA ophthalmic emulsion (FBA-EM) was prepared by high-pressure homogenization with caster oil as oil phase and tween 80 as emulsifying agent. Results from the stability evaluation suggested the protect effect of oil droplets on the stability of FBA. Compared with FBA-oil solution, the AUC(0→10h) of FB in aqueous humor administered in FBA-EMs exhibited 6.7-fold (F2), 4.5-fold (F3) and 4.6-fold (F4) increase. With the increment of oil content, the MRT also prolonged, which of FBA-EM F2-F4 were 5.14 ± 2.23, 5.73 ± 3.35 and 8.71 ± 0.94 h, respectively. No significant difference was found between the ocular bioavailability of FBA-EM F2 and 0.03% FB-Na eye drops. Ocular irritation evaluation revealed that FBA-EM F2 had better ocular biocompatibility than 0.03% FB-Na eye drops, even though the FBA concentration was up to 0.1%. Intraocular anti-inflammation effect evaluation showed that FBA-EM F2 had a quite good anti-inflammation effect. In conclusion, FBA-EM F2 with elevated FBA concentration to be 0.1% might represent a promising NSAIDs ophthalmic emulsion with low irritancy and improved anti-inflammation effect. Copyright © 2011 Elsevier B.V. All rights reserved.

  2. [Ophthalmic aspects in Celsus' work De medicina libri octo].

    PubMed

    Bieganowski, Lech

    2004-01-01

    The article presents Aulus Cornelius Celsus (living in Roman Empire 15 BC - 50 AD) and his famous work "De medicina libri octo", one of the main sources of knowledge on the ancient medicine. It briefly goes through the content of the medical treaties. A wider discussion of the following ophthalmic aspects, included in Book VI and Book VII, is provided: the anatomy of the eye, the description of ophthalmic diseases, methods of its preventive treatment and surgery. It is also mentioned that the work contains the first description of cataract surgery (couching method) in the medical literature. The article underlines the popularity enjoyed by Celsus' work in medieval Europe.

  3. Long-term follow-up of ophthalmic Graves' disease.

    PubMed Central

    Agapitos, P J; Hart, I R

    1987-01-01

    Sixteen patients with ophthalmic Graves' disease (clinically euthyroid with ophthalmopathy or exophthalmos) were followed up for 4.3 to 14.3 (mean 9.1) years to determine whether thyroid dysfunction developed and whether their ophthalmopathy progressed, regressed or remained stable. Five patients (31%) manifested hyperthyroidism or hypothyroidism, all before the end of the fifth year of follow-up. The ophthalmopathy was mild, and none of the patients required specific treatment. The thyroid function of patients with ophthalmic Graves' disease should be periodically monitored for at least 5 years. PMID:3815199

  4. 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.

  5. 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

  6. 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.

  7. Decadelong profile of women in ophthalmic publications.

    PubMed

    Franco-Cardenas, Valentina; Rosenberg, Jamie; Ramirez, Adriana; Lin, Juan; Tsui, Irena

    2015-03-01

    in ophthalmic literature, but no increase in editorial authorship.

  8. Thermoresponsive ophthalmic poloxamer/tween/carbopol in situ gels of a poorly water-soluble drug fluconazole: preparation and in vitro-in vivo evaluation.

    PubMed

    Lihong, Wang; Xin, Che; Yongxue, Guo; Yiying, Bian; Gang, Cheng

    2014-10-01

    The purpose of the present study was to optimize the formulations of the thermoresponsive ophthalmic in situ gels of a poorly water-soluble drug fluconazole (FLU) and evaluate the in vitro and in vivo properties of the formulations. The thermoresponsive ophthalmic FLU in situ gels were prepared by mixing FLU, Poloxamer407, Tween80, benzalkonium chloride and carbopol934 in borate buffer solution. The in vivo eye irritation tests and ophthalmic absorption were carried out in rabbits. The formulation compositions influenced the physicochemical properties of FLU in situ gels. The amount of poloxamer407 in the formulation was the main factor that affected the sol-gel transition temperature of the products. Tween80 not only improved the solubility of the FLU but also affected the products' sol-gel transition temperature. In this study, sol-gel transition temperature was not affected by carbopol934. However, carbopol934 affected pH value, transparency and gelling capacity of the products. The product of the optimized formulation was a pseudoplastic fluid and its sol-gel transition temperature was 30.6 ± 1.2 °C. The autoclaving test showed that the sol-gel transition temperature, the flow ability and the flow behavior of the test samples did not change obviously after autoclaving sterilization at 121 °C and 15 psi for 20 min, thus the autoclaving was an acceptable sterilization method for this preparation. The thermoresponsive ophthalmic FLU in situ gels' in vivo ophthalmic absorption was superior to the conventional FLU eye drop. In conclusion, the thermoresponsive ophthalmic FLU in situ gel is a better alternative than the FLU eye drop.

  9. 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

  10. 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 886.4250 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... ocular hair follicles by applying a galvanic electrical current. (b) Classification. Class I for the...

  11. Ophthalmic preservatives as absorption promoters for ocular drug delivery.

    PubMed

    Sasaki, H; Nagano, T; Yamamura, K; Nishida, K; Nakamura, J

    1995-09-01

    The effects of ophthalmic preservatives on the drug permeability through isolated ocular membranes of albino rabbits were investigated using a two-chamber glass diffusion cell. Tilisolol and fluorescein isothiocyanate (FITC)-dextrans (average molecular weights 4400 and 9400 Da; FD-4 and FD-10, respectively) were used as model penetrants of ophthalmic beta-blockers and peptide drugs. Preservatives significantly enhanced the corneal penetration of not only tilisolol but also FITC-dextrans. Especially, benzalkonium chloride increased the corneal permeability of FD-4 and FD-10 by 28.8 and 37.1 times, respectively. These results indicate the usefulness of ophthalmic preservatives as absorption promoters for the ocular delivery of beta-blockers and hydrophilic macromolecules. Preservatives also enhanced the conjunctival permeability of tilisolol, FD-4 and FD-10. The promoting effect of preservatives on the conjunctival drug penetration was smaller than that on the corneal one. Preservative increased the ratio of corneal to conjunctival permeability of tilisolol, FD-4 and FD-10. The different responses of corneal and conjunctival drug penetrations to ophthalmic preservatives may be useful to control the extent and pathway for the ocular and systemic absorptions of instilled drugs.

  12. 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...

  13. National Apprenticeship Standards for Ophthalmic Finisher-Dispenser.

    ERIC Educational Resources Information Center

    Manpower Administration (DOL), Washington, DC. Bureau of Apprenticeship and Training.

    The standards have been established and registered to advance the science of ophthalmic optics and assure the continuance of skilled and ethical practices in the optical processing and dispensing service by providing a recognized and formalized method of developing skilled craftsmen. Standards cover apprenticeship qualifications, agreement, terms,…

  14. Bilateral Ophthalmic Artery Dissecting Aneurysms Presenting with Recurrent Epistaxis

    PubMed Central

    Al Balushi, Ali; Kitchener, Jacob; Edgell, Randall C.

    2017-01-01

    We present a rare case of bilateral expanding traumatic pseudoaneurysms of the ophthalmic arteries, due to a gunshot. The aneurysms presented with epistaxis. After a failure of conservative management, coil embolization of the aneurysms resulted in complete occlusion, with preservation of flow in the parent vessels. PMID:28243345

  15. Numerical implementation of generalized Coddington equations for ophthalmic lens design

    NASA Astrophysics Data System (ADS)

    Rojo, P.; Royo, S.; Ramírez, J.; Madariaga, I.

    2014-02-01

    A method for general implementation in any software platform of the generalized Coddington equations is presented, developed, and validated within a Matlab environment. The ophthalmic lens design strategy is presented thoroughly, and the basic concepts of generalized ray tracing are introduced. The methodology for ray tracing is shown to include two inter-related processes. Firstly, finite ray tracing is used to provide the main direction of propagation of the considered ray at the incidence point of interest. Afterwards, generalized ray tracing provides the principal curvatures of the local wavefront at that point, and its orientation after being refracted by the lens. The curvature values of the local wavefront are interpreted as the sagital and tangential powers of the lens at the point of interest. The proposed approach is validated using a double-check of the calculated lens performance in the spherical lens case: while finite ray tracing is validated using a commercial ray tracing software, generalized ray tracing is validated using a software application for ophthalmic lens design based on the classical version of Coddington equations. Equations of the complete tracing process are developed in detail for the case of generic astigmatic ophthalmic lenses as an example. Three-dimensional representation of the sagital and tangential powers of the ophthalmic lens at all directions of gaze then becomes possible, and results are presented for lenses with different geometries.

  16. 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...

  17. 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...

  18. Effects of nonsteroidal ophthalmic drops on epithelial healing and pain in patients undergoing bilateral photorefractive keratectomy (PRK).

    PubMed

    Durrie, Daniel S; Kennard, Marla G; Boghossian, Allen J

    2007-01-01

    The present study, which was designed as a prospective, double-masked, randomized, controlled, single-site study, was conducted to compare the effects of 3 approved ophthalmic nonsteroidal anti-inflammatory drugs-nepafenac ophthalmic suspension 0.1% (Nevanac; Alcon Laboratories, Inc., Fort Worth, Tex), ketorolac tromethamine ophthalmic solution 0.4% (Acular LS; Allergan, Irvine, Calif), and bromfenac 0.09% (Xibromtrade mark; ISTA Pharmaceuticals, Irvine, Calif)-on corneal reepithelialization and postoperative pain control in patients undergoing photorefractive keratectomy. In addition to nonsteroidal anti-inflammatory drugs, each patient received an antibiotic-moxifloxacin hydrochloride ophthalmic solution 0.5% (nepafenac group) or gatifloxacin ophthalmic solution 0.3% (ketorolac and bromfenac groups). All treatments were administered 3 times daily beginning 1 d preoperatively and continuing for 1 wk postoperatively; prednisolone acetate 1.0% was administered concurrently 4 times daily. Bandage contact lenses were replaced at each postoperative visit for corneal staining and epithelial defect grading. Self-evaluation of pain relief was recorded on postoperative days 1 and 3 with the use of a visual analog scale. A total of 29 patients (58 eyes) were enrolled and underwent bilateral custom photorefractive keratectomy. Mean time to reepithelialization was 5.50+/-1.59 d for the nepafenac 0.1% group, 5.62+/-1.23 d for the ketorolac 0.4% group, and 7.25+/-2.53 d for the bromfenac 0.09% group. A significant difference was detected between nepafenac 0.1% and bromfenac 0.09% and between ketorolac 0.4% and bromfenac 0.09% (P<.05). Significant reductions in pain scores were observed with nepafenac 0.1% on day 1 (-1.13) and day 3 (-1.32), ketorolac 0.4% on day 3 (-0.88), and bromfenac 0.09% on day 3 (-0.83). No adverse events were reported. Eyes treated with nepafenac 0.1% or ketorolac 0.4% achieved complete reepithelialization significantly faster than those treated with

  19. Ion-activated In Situ Gelling Ophthalmic Delivery Systems of Azithromycin

    PubMed Central

    Vijaya, C.; Goud, K. Swetha

    2011-01-01

    Gelation of pectin caused by divalent cations especially calcium ions has been applied to develop an ophthalmic formulation of azithromycin in the present study. Rapid elimination of drug on instillation into cul de sac would be minimal with in situ gelling ophthalmic solution leading to increased precorneal contact time and prolonged drug delivery. In the formulation development studies pectin was used in different concentrations (1-5% w/v) and different proportions of the hydrocolloids hydroxypropyl methylcellulose and sodium carboxymethyl cellulose of different grades of viscosity were used. The primary criteria for formulation optimization were gelling capacity and rheological behaviour. In addition, formulations were evaluated for pH, and antimicrobial efficacy and drug release. The clarity, pH, gelation in simulated tear fluid and rheological properties of the optimized formulations were satisfactory. The formulations inhibited the growth of Staphylococcus aureus effectively in cup–plate method and were proved to be safe and non irritant on rabbit eyes. The results indicate that pectin based in situ gels can be successfully used to prolong the duration of action of azithromycin. PMID:23112394

  20. [Investigation of ophthalmic resources in Xinjiang Uyghur Autonomous Region in China].

    PubMed

    Maierdang, Ailimu; Maimaiti, Yasen; Liu, Li-ming; Fulati, Abudureyimu; Sha, Ying; Sun, Yong; Ding, Lin; Gulibahaer, Kadeer; Yang, Bo; Cao, Ming-qin

    2012-09-01

    To explore ophthalmic resources and existing problems in Xinjiang Uyghur Autonomous Region, and to provide reasonable developing configuration for the future. It was a population-based cross-section study. By using questionnaire to collect data from all eye units (national and private) which were registered in Xinjiang area. Investigation included: (1) ophthalmic medical unit of name, structure type, departments constitute; (2) the ophthalmic medical work; (3) the number of ophthalmology health technicians and distribution; (4) ophthalmic devices usage; (5) carry out the problems and difficulties encountered in ophthalmic work. Descriptive statistic method was used to analyze the structure of ophthalmic material, the availability of resource, the medical institution of different regions and types. One hundred and thirty questionnaire were filled out and 110 questionnaire were recovery. There were 107 eye units, 1709 beds for ophthalmic, 1672 employees, including 525 doctors, the ratio of doctors and nurses was 1.0:1.3. And the ophthalmic resources mainly distributed in northern Tianshan, very few in the eastern area in Xinjiang; ophthalmic units were denser in general hospitals which were above the county level. There were 43 580 ophthalmic surgeries in all, the main eye operation carried out was cataract surgery, including 20 303 (counted 46.59%) cataract operation. The ophthalmic units distribution is unbalanced, which is short of ophthalmologists. It provides base for government to arrange ophthalmic resources reasonably, to enhance the research motivation and to cultivate more professors, and to increase the number of ophthalmic specialists in the general hospitals, and eventually to maximize the benefit of ophthalmic service in Xinjiang.

  1. Safety of besifloxacin ophthalmic suspension 0.6% as a prophylactic antibiotic following routine cataract surgery: results of a prospective, parallel-group, investigator-masked study

    PubMed Central

    Malhotra, Ranjan; Gira, Joseph; Berdy, Gregg J; Brusatti, Robert

    2012-01-01

    Background The purpose of this study was to evaluate the safety and tolerability of besifloxacin ophthalmic suspension 0.6% compared with moxifloxacin ophthalmic solution 0.5%, when used for infection prophylaxis following uncomplicated phacoemulsification clear cornea surgery using sutureless corneal incision. Methods This prospective, two-site, parallel-group, investigator-masked clinical study included patients aged ≥18 years scheduled to undergo phacoemulsification with intraocular lens implantation. Patients received one drop of either besifloxacin ophthalmic suspension or moxifloxacin ophthalmic solution four times daily, beginning 3 days prior to surgery, which was continued for 7 days postoperatively. The primary endpoint was the rate of adverse events. Secondary endpoints included endothelial cell count, central corneal thickness, and overall and central corneal staining measured on days 7 (±1 day) and 28 (±2 days) following surgery, and intraocular pressure and best-corrected visual acuity measured on days 1, 7 (±1 day), and 28 (±2 days) following surgery. Results Of the 60 patients enrolled, 58 (29 per treatment group) completed the study. No adverse events were reported in either treatment group. Changes in the central corneal thickness, endothelial cell count, and corneal staining were small and similar between treatments at follow-up visits (P ≥ 0.1549). Intraocular pressure was similar between treatment groups at each visit, as was the distribution of best-corrected visual acuity. The final best-corrected visual acuity was 20/30 or better in 85% of the patients. Conclusion In this study, besifloxacin ophthalmic suspension 0.6% was well tolerated when used prophylactically to prevent postoperative endophthalmitis following sutureless cataract surgery. PMID:22701313

  2. Rapid determination of total benzalkonium chloride content in ophthalmic formulation.

    PubMed

    Labranche, Louis-Philippe; Dumont, Suzanne N; Levesque, Suzanne; Carrier, Alain

    2007-02-19

    A simple and rapid reversed-phase HPLC method was developed for routine analysis of total benzalkonium chloride in ophthalmic formulations. The analysis involves simple sample preparation using the mobile phase as the diluent. The method uses a Waters SymmetryShield RP-18 (75 mm x 4.6 mm, 3.5 microm particle size) column and a mobile phase consisting of a mixture of methanol-potassium phosphate (pH 3.0; 7.5 mM) (68:32, v/v). Using these conditions, three major homologs of the benzalkonium chloride (C(12), C(14) and C(16)) were separated in less then 7 min. Furthermore, recoveries ranging from 97% to 99% at three levels of the label claim of total benzalkonium chloride content were obtained for different ophthalmic formulations. Data supporting the development and validation of this method are presented.

  3. Blindness resulting from orbital complications of ophthalmic zoster

    PubMed Central

    Sosnowska, Magdalena; Zajkowska, Agata; Garkowski, Adam; Czupryna, Piotr; Pancewicz, Sławomir; Zajkowska, Joanna

    2015-01-01

    Herpes zoster ophthalmicus occurs when the latent varicella zoster virus (VZV) reactivates in the trigeminal ganglion and ophthalmic branch of the trigeminal nerve. In the elderly, there is a sharp increase in the tendency of secondary skin bacterial infections occurrence due to the deterioration of capabilities of self-care and changed sanitation. We present a case of patient who developed phlegmon of the orbit, which resulted with complete unilateral blindness. Varicella zoster virus infection in the elderly may have a severe course due to the progressive weakening of the immune system related to the age. Moreover, skin lesions around the eye socket require special care in prevention of bacterial superinfections due to the extremely high risk of life-threatening complications or disability. Neuralgia resistant to pharmacological treatment present in the course of ophthalmic zoster and difficulty in caring about skin lesions predispose to the occurrence of complications. PMID:26759550

  4. Video recording of ophthalmic surgery--ethical and legal considerations.

    PubMed

    Turnbull, Andrew M J; Emsley, Elizabeth S

    2014-01-01

    Video documenting is increasingly used in ophthalmic training and research, with many ophthalmologists routinely recording their surgical cases. Although this modality represents an excellent means of improving technique and advancing knowledge, there are major ethical and legal considerations with its use. Informed consent to record is required in most situations. Patients should be advised of any risk of identification and the purpose of the recording. Systems should be in place to deal with issues such as data storage, withdrawal of consent, and patients requesting copies of their recording. Privacy and security of neither patients nor health care professionals should be compromised. Ownership and distribution of video recordings, the potential for their use in medical litigation, the ethics and legality of editing and the impact on surgeon performance are other factors to consider. Although video recording of ophthalmic surgery is useful and technically simple to accomplish, patient safety and welfare must always remain paramount. Copyright © 2014 Elsevier Inc. All rights reserved.

  5. Perspective on ophthalmic support in countries of the developing world.

    PubMed

    Muecke, James; Sia, David I T; Newland, Henry; Casson, Robert J; Selva, Dinesh

    2013-04-01

    There are over 300 million people living in the world today who are visually impaired and a further 45 million who are blind. The large majority (90%) of these people live in developing countries, and up to 75% of blindness are avoidable. With cataracts being the major cause of blindness and visual impairment, many ophthalmic aid programmes are aimed at alleviating the enormous burden caused by this readily treatable disease. Having said that, caution should be exercised that short surgical visits to remote rural areas that are not coordinated with local national eye care managers should be discouraged because they do little for the development of sustainable eye care programmes. With this in view, it has become imperative to design blindness prevention and ophthalmic support programmes that are workable, comprehensive, economical and sustainable.

  6. Neuro-Ophthalmic Manifestations of Pediatric Neurodegenerative Disease.

    PubMed

    Heidary, Gena

    2017-09-01

    The topic of pediatric neurodegenerative disease is broad and ever expanding. Children who suffer from neurodegenerative disease often have concomitant visual dysfunction. Neuro-ophthalmologists may become involved in clinical care to identify corroborating eye findings when a specific condition is suspected, to monitor for disease progression, and in some cases, to assess treatment efficacy. Ophthalmic findings also may be the harbinger of a neurodegenerative process so a keen awareness of the possible manifestations of these conditions is important. The purpose of this review is to highlight common examples of the neuro-ophthalmic manifestations of pediatric neurodegenerative disease using a case-based approach in an effort to provide a framework for approaching these complex patients.

  7. Pediatric ophthalmic indications for examination under anesthesia in Ilorin, Nigeria.

    PubMed

    Mahmoud, Abdulraheem Olarongbe; Ayanniyi, Abdulkabir Ayansiji; Oyedepo, Olanrewaju Olubukola

    2010-01-01

    To determine the ophthalmic indications and challenges for pediatric ocular examination under anesthesia (EUA). The surgical register and patients' records of children who underwent EUA between 1990 and 2007 were examined to document patients' bio data, diagnoses and details of procedures and anesthesia. Thirty-nine children underwent EUA during the 18-year period. The indications included congenital glaucoma (20 cases, 21.3%) and congenital cataract (5 cases, 12.8%). There were two cases each (5.1%) of microphthalmia, megalocornea, and squint. A case each of other indications constituted the remaining 10.3%. The commonest ophthalmic indication for EUA among children is congenital glaucoma. Most of the children (36, 92.3%) had inhalational anesthesia administered by anesthetists at great cost to their parents. We recommend the use of ketamine anesthesia administered by nonanesthetist with some training in anesthetic resuscitation procedure, for short pediatric procedure such as EUA in resource-challenged settings.

  8. Fluorometholone acetate. A new ophthalmic derivative of fluorometholone.

    PubMed

    Kupferman, A; Berrospi, A R; Leibowitz, H M

    1982-04-01

    Hourly topical administration of 0.1% fluorometholone acetate ophthalmic suspension produced, on the average, a 47% reduction in the polymorphonuclear leukocytes invading the cornea during an experimentally induced inflammatory keratitis. This is a significantly greater anti-inflammatory effect than we have previously reported for the alcohol derivative of fluorometholone and is not significantly different from the therapeutic effect of 1.0% prednisolone acetate ophthalmic suspension, the most effective corneal anti-inflammatory agent that we have studied to date. Fluorometholone acetate (0.1%) formulated as a high-viscosity carbomer gel and applied at three-hour intervals reduced invading leukocytes in the cornea an average of 48%, an effect not significantly different from hourly administration of the suspension.

  9. Gradient-index ophthalmic lens design and polymer material studies

    NASA Astrophysics Data System (ADS)

    Fischer, David Joel

    Unifocal ophthalmic lenses are conventionally designed using homogeneous glass or plastic materials and aspheric surfaces. The desired power and aberration correction are provided by selection of surface shape and refractive index. This thesis studies the design of ophthalmic lenses utilizing gradient-index (GRIN) materials for both the optical power and aberration control. This is done using geometrical optical theory and ray-tracing simulations. Progressive addition lenses (PALS) are vision correction lenses with a continuous change in power used to treat presbyopia. The power variation is typically located in the lower half of the lens. Progressive addition lenses are currently made with aspheric surfaces to achieve the focal power transition and aberration control. These surfaces have at most, mirror symmetry about the vertical axis. The possible design of progressive addition lenses with GRIN materials has not been well studied. This thesis studies PALS and identifies how gradient-index materials can be used to provide both the power progression and aberration control. The optical theory for rotationally symmetric and asymmetric power additions is given. Analytical and numerical methods for calculating the index profile are used, and the results examined using ray-tracing simulations. The theory developed for ophthalmic lenses is applied to the design of GRIN axicon. This is the first GRIN axicon manufactured, and is fabricated using ion-exchanged GRIN glass. Experimental measurements of its performance are compared and found to match theoretical predictions. This demonstrates the generality of the theory developed: it may be applied to non-visual applications, and even to non-imaging applications. Realistic implementation of GRIN technology to ophthalmic application requires the fabrication of large scale refractive index gradients in polymer material systems. The methyl-methacrylate/styrene copolymer system is studied to develop an empirical model of its

  10. Corneal contact times of ophthalmic vehicles. Evaluation by microscintigraphy.

    PubMed

    Trueblood, J H; Rossomondo, R M; Wilson, L A; Carlton, W H

    1975-02-01

    Lacrimal microscintigraphy, in conjunction with a recently developed computer system, was used to evaluate the corneal contact time of three ophthalmic vehicles in 18 humans. The percentage of a radioactively labeled vehicle remaining over the cornea after 90 seconds was 2.9% plus and minus 2.2% for saline, 4.3% plus and minus 2.4% for polyvinyl alcohol, and 8.8% plus and minus 4.1% for hydroxypropyl methylcellulose.

  11. Development of Absorbable, Antibiotic-Eluting Sutures for Ophthalmic Surgery

    PubMed Central

    Kashiwabuchi, Fabiana; Parikh, Kunal S.; Omiadze, Revaz; Zhang, Shuming; Luo, Lixia; Patel, Himatkumar V.; Xu, Qingguo; Ensign, Laura M.; Mao, Hai-Quan; Hanes, Justin; McDonnell, Peter J.

    2017-01-01

    Purpose To develop and evaluate an antibiotic-eluting suture for ophthalmic surgery. Methods Wet electrospinning was used to manufacture sutures composed of poly(L-lactide), polyethylene glycol (PEG), and levofloxacin. Size, morphology, and mechanical strength were evaluated via scanning electron microscopy and tensile strength, respectively. In vitro drug release was quantified using high performance liquid chromatography. In vitro suture activity against Staphylococcus epidermidis was investigated through bacterial inhibition studies. Biocompatibility was determined via histological analysis of tissue sections surrounding sutures implanted into Sprague-Dawley rat corneas. Results Sutures manufactured via wet electrospinning were 45.1 ± 7.7 μm in diameter and 0.099 ± 0.007 newtons (N) in breaking strength. The antibiotic release profile demonstrated a burst followed by sustained release for greater than 60 days. Increasing PEG in the polymer formulation, from 1% to 4% by weight, improved drug release without negatively affecting tensile strength. Sutures maintained a bacterial zone of inhibition for at least 1 week in vitro and elicited an in vivo tissue reaction comparable to a nylon suture. Conclusions There is a need for local, postoperative delivery of antibiotics following ophthalmic procedures. Wet electrospinning provides a suitable platform for the development of sutures that meet size requirements for ophthalmic surgery and are capable of sustained drug release; however, tensile strength must be improved prior to clinical use. Translational Relevance No antibiotic-eluting suture exists for ophthalmic surgery. A biocompatible, high strength suture capable of sustained antibiotic release could prevent ocular infection and preclude compliance issues with topical eye drops. PMID:28083445

  12. [Bibliometric analysis of the current international ophthalmic publications].

    PubMed

    Ohba, Norio

    2005-03-01

    To assess the current status of international ophthalmic publications. A collection of 55,591 original articles were found by an on-line National Library of Medicine database Medline search for 32 international ophthalmic journals during a 15-year period from 1988 to 2002 (internet access, November 11-13, 2003). The contributions to international ophthalmic publications were by 49.5% from North America, 31.3% from Western Europe, 15.1% from Asia and Oceania, 2.2% from Middle East, 0.85% from Central and South America, 0.53% from Eastern Europe, and 0.47% from Africa. Countries of Asia and Oceania showed an increasing trend in contributions while North America had a decreasing productivity in a relative sense. The top 10 productive countries were USA, United Kingdom, Japan, Germany, Canada, Australia, Italy, Netherlands, Sweden, and France. Among the Asian countries India ranked 13th, China 18th, and Korea 21st. When related to population, small countries such as Israel, France, Finland, Sweden, and Denmark were more productive. When related to economic productivity as defined by GDP, Israel, the United Kingdom, Australia, Finland, and Sweden were among the most productive countries, whereas rich countries such as Japan and Germany had a lower number of publications relative to their GDP. As regards clinical research in terms of randomized controlled trials, The USA was by far the most productive. The number of authors per article has shown an increasing trend worldwide, so that Japan and France had a significantly larger proportion of multiauthored articles. There is an increasing trend in the productivity of international ophthalmic publications from non-English-speaking countries including Japan, China, and Korea.

  13. Regional ophthalmic anesthesia: safe techniques and avoidance of complications.

    PubMed

    Troll, G F

    1995-03-01

    In the last decade, anesthesiologists have become increasingly involved in administering regional eye blocks, while providing care for patients undergoing ophthalmic surgery. This article describes the two major approaches to regional eye block, namely retrobulbar and peribulbar, with special consideration given to relevant orbital anatomy and technical guidelines. Potential complications, ocular and systemic, with their risk factors, are reviewed. Anesthesiologists wishing to acquire skill in administering safe regional blockade are encouraged to familiarize themselves with regional anatomy and specific guidelines suggested herein.

  14. OPHTHALMIC FINDINGS IN LATE STAGE SJOGREN-LARSSON SYNDROME.

    PubMed

    Nanda, Tavish; Kovach, Jaclyn L

    2017-03-15

    To report spectral domain optical coherence tomography and fundus autofluorescence documentation of late stage macular findings associated with Sjogren-Larsson Syndrome in three adult siblings. Three adult siblings with Sjogren-Larsson Syndrome underwent ophthalmic examination and imaging. Crystalline maculopathy and subretinal deposits, presumably lipofuscin accumulation, with macular atrophy were present in varying degrees in all three adult siblings. In adults with Sjogren-Larsson Syndrome, crystalline retinopathy can progress to macular atrophy and the appearance of lipofuscin accumulation.

  15. Pituitary apoplexy presenting atypical time course of ophthalmic symptoms.

    PubMed

    Enatsu, Rei; Asahi, Minoru; Matsumoto, Masato; Hirai, Osamu

    2012-05-01

    Pituitary apoplexy is defined as a sudden loss of blood supply to the pituitary gland, leading to tissue necrosis and hemorrhage. Its clinical symptoms are characterized by sudden onset of headache, nausea, vomiting, ophthalmic symptoms and hormonal dysfunction. A 65-year-old woman presented with left-sided ptosis and blurred vision. These ophthalmic symptoms gradually worsened for one month without headache, visual acuity and field deficit. Neuro-ophthalmic examination revealed left oculomotor nerve palsy. Magnetic resonance imaging (MRI) revealed a round mass lesion in the left cavernous sinus, which was initially suspected as thrombosed cerebral aneurysm or hemorrhagic Rathke's cleft cyst. The mass lesion was finally diagnosed as pituitary apoplexy. The patient underwent trans-sphenoidal surgery and oculomotor nerve palsy improved after the surgery. Early diagnosis and treatment including surgical decompression are crucially important in patients with oculomotor nerve palsy in pituitary apoplexy, but the symptoms of pituitary apoplexy may slowly progress. It should be noted that pituitary apoplexy could be misdiagnosed as cerebral aneurysm or Rathke's cleft cyst.

  16. Description of Ophthalmic Pharmaceutical and Device Start-Up Companies.

    PubMed

    Sharpe, R Allan; Austin, Jennifer P; Kruft, Bonnie; Nelson, Lindsay A; Stewart, Jeanette A; Stewart, William C

    2015-01-01

    To describe the number, type and location of ophthalmic companies and their associated product areas and indications. A retrospective, non-patient-based, observational review of ophthalmic pharmaceutical and device companies with a new product in development. Data was compiled by Internet searches. We identified 190 companies currently developing ophthalmic products: 134 (71%) were privately held and 56 (29%) publicly held, while 136 (72%) were in the United States and 53 (28%) were outside the United States. There were 436 total products of which 338 (78%) were pharmaceuticals and 98 (22%) devices. With pharmaceuticals we identified 46 separate indications with age-related macular degeneration (n = 75), glaucoma (n = 52) and dry eye (n = 46) as most common; anti-vascular endothelial growth factor, hormone therapy and anti-inflammatory products were also common classes. With devices there were 30 indications with glaucoma (n = 26), age-related macular degeneration (n = 19) and dry eye (n = 6) as most common; drug delivery, ocular implants and prostheses were less common classes. Ophthalmology as a specialty is benefited by a wide effort in new medicine and device development. However, a concentration of effort into relatively few indications suggests a potential lack of market analysis and possible difficulty for many companies in commercializing their product. © 2015 S. Karger AG, Basel.

  17. One-Year Progress in Ophthalmic Education: Annual Review.

    PubMed

    Mayorga, Eduardo; Golnik, Karl; Palis, Gabriela

    2015-01-01

    The aim of this study was to update the practicing ophthalmologist on the English language literature about medical education from the prior year. A search of English language literature was performed on PubMed from January 1, 2014, to December 31, 2014. Because the search using the main topic of the review "medical education" came up with 7394 citations, authors finally decided to narrow the search to 3 topics of their interest:1. Current state of competency-based education and teaching methods of competencies. This section included ophthalmic/ophthalmology education, core competencies, competency-based education, teaching strategies, tools and methods in medical education.2. E-learning. This section included e-learning, online learning, online teaching, Web-based teaching, Web-based learning, and flipped classroom.3. This section included assessment of medical students, residents, fellows, faculty, attending physicians, and medical teachers, assessment of medical student ophthalmology programs, ophthalmology residency programs, residency programs, and fellowship programs. The authors reviewed and summarized articles published in 2014 examining or describing the 3 main areas of the review described previously. This review updates the comprehensive ophthalmologist on advances in ophthalmic medical education. Ophthalmic educators could apply the ideas presented in this review according to their possibilities in their own settings and programs.

  18. Physicochemical attributes and dissolution testing of ophthalmic ointments.

    PubMed

    Bao, Quanying; Jog, Rajan; Shen, Jie; Newman, Bryan; Wang, Yan; Choi, Stephanie; Burgess, Diane J

    2017-05-15

    The investigation of semisolid ophthalmic ointments is challenging due to their complex physicochemical properties and the unique anatomy of the human eye. Using Lotemax(®) as a model ophthalmic ointment, three different manufacturing processes and two excipient sources (Fisher(®) (OWP) and Fougera(®) (NWP)) were used to prepare loteprednol etabonate ointments that were qualitatively and quantitatively the same across the manufactured formulations. Physicochemical properties including drug content and uniformity, particle size and distribution, as well as rheological parameters (onset point, crossover modulus, storage modulus and Power law consistency index) were investigated. In addition, USP apparatus 2 with enhancer cells was utilized to study the in vitro drug release characteristics of the ophthalmic ointments. Both manufacturing processes and excipient sources had a significant influence on the physicochemical attributes and the in vitro drug release profiles of the prepared ointments. Ointments prepared via the hot melt processes exhibited higher rheological parameters and lower drug release rates compared to ointments prepared without hot melting. Ointments prepared with OWP demonstrated higher rheological parameters and lower in vitro drug release rates compared to ointments prepared with NWP. A strong correlation between the rheological parameters and in vitro drug release rate was shown using logarithmic linear regression. This correlation may be useful in predicting in vitro drug release from measured physicochemical properties, and identifying the critical quality attributes during the development of ointment formulations. Copyright © 2017 Elsevier B.V. All rights reserved.

  19. Effect of ophthalmic preservatives on serum concentration and local irritation of ocularly applied insulin.

    PubMed

    Sasaki, H; Tei, C; Nishida, K; Nakamura, J

    1995-01-01

    We previously compared hypoglycemic responses after the instillation of insulin formulations. A hypoglycemic response was actually observed after an instillation of insulin with ophthalmic preservatives. In the present study, in order to evaluate the usefulness of insulin formulation containing ophthalmic preservatives, a serum concentration of insulin and an irritation to the eye were investigated after instillation of the insulin formulation in albino rabbits. The ophthalmic preservatives used were benzalkonium chloride, paraben, 2-phenylethanol, benzyl alcohol and sorbic acid. As a result, ophthalmic preservatives, especially benzalkonium chloride and paraben, increased the serum concentration of insulin. The insulin concentration showed a significant correlation with the hypoglycemic response reported previously. This result indicates that ophthalmic preservatives increase the absorption of ocularly applied insulin, and the absorbed insulin decreases serum glucose concentration. The insulin formulation with preservatives showed little irritation on rabbit eyes according to blinking measurements. These results indicate that ophthalmic preservatives are useful for the systemic delivery of ocularly applied insulin.

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. The Preliminary Development of a Robotic Laser System Used for Ophthalmic Surgery

    DTIC Science & Technology

    1988-01-01

    34 - % - S THE PRELIMINARY DEVELOPMENT OF A ROBOTIC LASER SYSTEM USED FOR OPHTHALMIC SURGERY Publication No. Michael Stephen Markow, Ph.D. The University...generation robotic laser system used for ophthalmic surgery . The goal of this research project is to develop an automated laser delivery and retinal...4 THE PRELIMINARY DEVELOPMENT OF A ROBOTIC LASER SYSTEM USED FOR OPHTHALMIC SURGERY I APPROVED BY SUPERVISORY COMMITTEE: I S VA THE

  5. An Ophthalmic Formulation of Disulfiram Nanoparticles Prolongs Drug Residence Time in Lens.

    PubMed

    Nagai, Noriaki; Mano, Yu; Ito, Yoshimasa

    2016-01-01

    Disulfiram (DSF) is a dimer of diethyldithiocarbamate (DDC) that we previously added to a solution of 2-hydroxypropyl-β-cyclodextrin (DSF solution). We found that the instillation of this DSF solution delayed lens opacification in a hereditary cataractous ICR/f rat. In this study, we attempted to design an ophthalmic formulation containing DSF nanoparticles for use as a lens targeted drug delivery system (nano-DSF suspension), and investigated the changes in drug content in the lens after the instillation of DSF solution or nano-DSF suspension. The nano-DSF suspension was prepared by a bead mill method to yield a mean particle size of nano-DSF of 181 nm. Following the instillation of 1.4% DSF solution or the nano-DSF suspension, DDC was detected only in the aqueous humor and lens; in both, the area under the curve (AUC) and mean residence time (MRT) for the nano-DSF suspension were higher than for the DSF solution. In addition, we found that the DDC residence time in the cortex and nucleus of the lens was higher than in the capsule-epithelium. Although DDC was not detected in the cortex and nucleus of lenses following the instillation of the 1.4% DSF solution, the instillation of a 1.4% nano-DSF suspension led to the accumulation of DDC in both areas. In conclusion, it is possible that the instillation of a nano-DSF suspension can supply more DDC into the aqueous humor and lens than a conventional formulation, and these findings provide information significant for the prevention of cataracts and the design of a lens targeted drug delivery system.

  6. Assessment of the precorneal residence of an ophthalmic ointment in healthy subjects.

    PubMed Central

    Greaves, J L; Wilson, C G; Birmingham, A T

    1993-01-01

    1. The precorneal residence of an ophthalmic ointment radiolabelled by inclusion of technetium-99m tin colloid was assessed in seven volunteer subjects using the technique of gamma scintigraphy and compared with a solution of 0.3% w/v hydroxypropylmethylcellulose, (HPMC) radiolabelled by inclusion of technetium-99m diethylenetriaminepentaacetic acid in the same subjects. 2. The mean half-times (+/- s.d.) of corneal residence were 6490 +/- 5404 s (108 min) for the ointment and 13 +/- 24 s for the 0.3% w/v HPMC solution (P < 0.01). 3. The area-under-curve value (AUC(0,540 s)), which reflects the total residence time of the preparation on the ocular surface, was calculated for each vehicle in each subject. The mean (+/- s.d.) AUC(0,540 s) value for the ointment was 42170 (+/- 5032)% s and for the 0.3% w/v HPMC solution it was 8394 (+/- 4641)% s (P < 0.01). PMID:8443038

  7. Tear fluid collection in dogs and cats using ophthalmic sponges.

    PubMed

    Sebbag, Lionel; Harrington, Danielle M; Mochel, Jonathan P

    2017-08-27

    To compare the use of two ophthalmic sponges for tear collection in dogs and cats. Ten healthy dogs and 10 healthy cats. A strip (4 × 10 mm) of either cellulose or polyvinyl acetal (PVA) sponge was inserted into the ventral fornix of each eye for either 15, 30, or 60 s. The wetted strip was placed into a 0.2-mL tube that was first punctured at its bottom. Tears were eluted through the drainage hole into a 1.5-mL tube via centrifugation. Tear volume absorbed (VA) and tear volume recovered (VR) were calculated as the difference of the post- and precollection weight of the 0.2-mL tube and 1.5-mL tube, respectively. Recovery ratio (RR) was determined as the ratio between VR and VA. Ophthalmic sponges were well tolerated by all subjects. In dogs and cats, median (95% range) VA, VR, and RR were as follows: 44 μL (11-106 μL) and 16 μL (2-43 μL); 27 μL (1-84 μL) and 6 μL (0-29 μL); 64% (7-91%) and 35% (0-86%), respectively. PVA sponges achieved significantly greater VR in cats and RR in both species. All parameters were significantly greater with a collection time of 60 vs. 30 and 15 s. Body weight was associated with VA and VR in dogs but not cats. Polyvinyl acetal is better than cellulose for tear collection given its superior recovery. Ophthalmic sponges could facilitate routine analysis of tear fluid in dogs and cats, although further studies are needed to evaluate the quality of tears obtained with this method. © 2017 American College of Veterinary Ophthalmologists.

  8. External ocular motor palsies in ophthalmic zoster: a review.

    PubMed Central

    Marsh, R J; Dulley, B; Kelly, V

    1977-01-01

    Seventy-seven new patients suffering from ophthalmic zoster and a selected group of 69 old patients were carefully examined with regard to external ocular movements. An incidence of 31% of ocular pareses was found in the new patients, and 58 in all were analysed. We were surprised to find several of these were contralateral and bilateral palsies. 28% of the palsies were asymptomatic, due to diplopia being present only in extremes of gaze and the rapid development of suppression in the affected eye. The theories of aetiology of these pareses are discussed. PMID:338027

  9. Dual-thread parallel control strategy for ophthalmic adaptive optics.

    PubMed

    Yu, Yongxin; Zhang, Yuhua

    To improve ophthalmic adaptive optics speed and compensate for ocular wavefront aberration of high temporal frequency, the adaptive optics wavefront correction has been implemented with a control scheme including 2 parallel threads; one is dedicated to wavefront detection and the other conducts wavefront reconstruction and compensation. With a custom Shack-Hartmann wavefront sensor that measures the ocular wave aberration with 193 subapertures across the pupil, adaptive optics has achieved a closed loop updating frequency up to 110 Hz, and demonstrated robust compensation for ocular wave aberration up to 50 Hz in an adaptive optics scanning laser ophthalmoscope.

  10. Ophthalmic manifestations in IgG4-related disease

    PubMed Central

    Ebbo, Mikael; Patient, Matthieu; Grados, Aurelie; Groh, Matthieu; Desblaches, Julien; Hachulla, Eric; Saadoun, David; Audia, Sylvain; Rigolet, Aude; Terrier, Benjamin; Perlat, Antoinette; Guillaud, Constance; Renou, Frederic; Bernit, Emmanuelle; Costedoat-Chalumeau, Nathalie; Harlé, Jean-Robert; Schleinitz, Nicolas

    2017-01-01

    Abstract IgG4-related disease (IgG4-RD) is characterized by variable tissue or organ involvements sharing common pathological findings. Orbital or orbital adnexa involvement of the disease has been reported in a few case series. The aim of our study was to characterize and analyze ophthalmic manifestations from a nationwide French case-series. Patients with IgG4-RD and orbital or orbital adnexa involvement included in the French multicentric IgG4-RD case-registry were identified. Only patients fulfilling “modified” comprehensive diagnostic criteria with pathological documentation were retained for the study. Clinical, biological, pathological, radiological findings and data regarding the response to treatment were retrospectively analyzed. According to our data registry, the frequency of IgG4-related ophthalmic disease (IgG4-ROD) was 17%. Mean age at diagnosis was 55.1 ± 7.1 years with a male/female ratio of 2.2. The 19 cases of IgG4-ROD consisted of lacrimal gland (68.4%), soft tissue (57.9%), extra-ocular muscles (36.8%), palpebral (21.1%), optical nerve (10.5%), orbital bone (10.5%), and mononeuritis (V1 and/or V2, 10.5%) involvements. IgG4-ROD was bilateral in 57.9% of cases. Extra-ophthalmic manifestations were reported in 78.9% of cases. All patients responded to prednisone but two-thirds of patients relapsed within a mean (SD) of 9.8 (3.5) months and 72.2% required long-term glucocorticoids and/or immunosuppressive agents. Eight patients were treated by rituximab with a favorable response in 87.5% of cases. Lacrimal involvement is the most frequent ophthalmic manifestation of IgG4-RD and is frequently associated with extra-orbital manifestations. Despite initial favorable response to steroids, the long-term management of relapsing patients needs to be improved. PMID:28272212

  11. Ophthalmic manifestations of tuberous sclerosis: a population based study

    PubMed Central

    Rowley, S; O'Callaghan, F; Osborne, J

    2001-01-01

    BACKGROUND/AIMS—Tuberous sclerosis complex (TSC) has retinal and non-retinal ophthalmic manifestations. This study was designed to determine the prevalence of the ophthalmic manifestations and of refractive errors in a population of patients with TSC.
METHODS—179 patients identified were in a prevalence study of TSC in the south of England and 107 of these agreed to full ophthalmic examination which was successful in 100. Ophthalmic examination included examination of the eyelids, cover test, examination of the irides, dilation funduscopy using both direct and indirect ophthalmoscopy, and refraction using retinoscopy. Myopia was defined as a spherical equivalent <−0.5D and hyperopia as a spherical equivalent >+0.5D.
RESULTS—Retinal hamartomas were seen in 44 of the 100 patients. The commonest morphological type of hamartoma seen was the flat, translucent lesion in 31 of the 44 patients (70%). The multinodular "mulberry" lesion was seen in 24 of the 44 patients (55%) and the transitional type lesion was seen in four of the 44 patients (9%). Punched out areas of retinal depigmentation were seen in 39 of the 100 patients but only six of 100 controls. 27% of eyes were myopic, 22% were hyperopic, and 27% had astigmatism >0.75D. Of the non-retinal findings, 39 patients had angiofibromas of the eyelids, five had non-paralytic strabismus, and three had colobomas.
CONCLUSION—Apart from the higher prevalence of flat retinal hamartomas, the findings of this study compare closely with previous large clinic based series of TSC patients. Refractive findings were similar to previous studies of a similarly aged non-TSC population. This is the first series to document the statistically significant association of punched out chorioretinal depigmentation with TSC and the authors believe that it should be looked for as an aid to diagnosis.

 PMID:11264130

  12. 21 CFR 524.1200 - Kanamycin 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 Kanamycin ophthalmic and topical dosage forms. 524.1200 Section 524.1200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... ANIMAL DRUGS § 524.1200 Kanamycin ophthalmic and topical dosage forms. ...

  13. 21 CFR 524.1200 - Kanamycin 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 Kanamycin ophthalmic and topical dosage forms. 524.1200 Section 524.1200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... ANIMAL DRUGS § 524.1200 Kanamycin ophthalmic and topical dosage forms. ...

  14. 21 CFR 524.1200 - Kanamycin 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 Kanamycin ophthalmic and topical dosage forms. 524.1200 Section 524.1200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... ANIMAL DRUGS § 524.1200 Kanamycin ophthalmic and topical dosage forms....

  15. 21 CFR 524.1200 - Kanamycin 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 Kanamycin ophthalmic and topical dosage forms. 524.1200 Section 524.1200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... ANIMAL DRUGS § 524.1200 Kanamycin ophthalmic and topical dosage forms....

  16. 21 CFR 524.1200 - Kanamycin ophthalmic and topical dosage forms.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Kanamycin ophthalmic and topical dosage forms. 524.1200 Section 524.1200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... ANIMAL DRUGS § 524.1200 Kanamycin ophthalmic and topical dosage forms....

  17. 77 FR 42503 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-19

    ... HUMAN SERVICES Food and Drug Administration Ophthalmic Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Ophthalmic Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  18. 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

    ... HUMAN SERVICES Food and Drug Administration Ophthalmic Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Ophthalmic Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  19. Selective thrombolysis performed through meningo-ophthalmic artery in central retinal artery occlusion.

    PubMed

    Cohen, José E; Moscovici, Samuel; Halpert, Michael; Itshayek, Eyal

    2012-03-01

    The poor natural history of central retinal artery occlusion (CRAO) is usually not modified with conventional, conservative management techniques. Guidelines for selective intraarterial ophthalmic thrombolysis are still lacking. While many centers continue to perform this procedure with promising results, others are reluctant due to conflicting findings in recent studies. We present our experience in a 36-year-old male with CRAO. Based on the patient's clinical presentation, we planned to perform selective intraarterial ophthalmic thrombolysis via the ophthalmic artery. When angiography demonstrated that the retina was not supplied by the ophthalmic artery, but by a meningo-ophthalmic artery branching from the internal maxillary artery, we instead administered thrombolytic agents via the meningo-ophthalmic artery. The patient's vision recovered completely, with visual acuity and visual field examination at 30 day follow up comparable to his pre-treatment status. This case emphasizes the need for external carotid artery examination in cases of nonvisualization of the ophthalmic artery. In addition, it illustrates the successful use of the meningo-ophthalmic artery to perform selective intraarterial thrombolysis for CRAO. Copyright © 2011 Elsevier Ltd. All rights reserved.

  20. 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.

  1. 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. ...

  2. 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... with other antibiotics, prolonged use may result in overgrowth of nonsusceptible organisms....

  3. 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 an AC-powered device that is a microscope and dial gauge intended to measure the radius of a...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 75 FR 26264 - Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-11

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Dermatologic and Ophthalmic Drugs Advisory Committee; Notice... be open to the public. Name of Committee: Dermatologic and Ophthalmic Drugs Advisory Committee...

  11. 76 FR 30176 - Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-24

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Dermatologic and Ophthalmic Drugs Advisory Committee; Notice... be open to the public. Name of Committee: Dermatologic and Ophthalmic Drugs Advisory Committee...

  12. 21 CFR 524.1881 - Prednisolone acetate 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 Prednisolone acetate ophthalmic and topical dosage forms. 524.1881 Section 524.1881 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... NEW ANIMAL DRUGS § 524.1881 Prednisolone acetate ophthalmic and topical dosage forms. ...

  13. 21 CFR 524.1881 - Prednisolone acetate 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 Prednisolone acetate ophthalmic and topical dosage forms. 524.1881 Section 524.1881 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... NEW ANIMAL DRUGS § 524.1881 Prednisolone acetate ophthalmic and topical dosage forms. ...

  14. 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....432; and (2) For each decay calculation, the date and the source activity as determined under § 35.433. ...

  15. 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....432; and (2) For each decay calculation, the date and the source activity as determined under § 35.433. ...

  16. 21 CFR 524.1883 - Prednisolone sodium phosphate-neomycin sulfate ophthalmic ointment.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Prednisolone sodium phosphate-neomycin sulfate... DOSAGE FORM NEW ANIMAL DRUGS § 524.1883 Prednisolone sodium phosphate-neomycin sulfate ophthalmic ointment. (a) Specifications. Prednisolone sodium phosphate-neomycin sulfate ophthalmic ointment contains...

  17. 21 CFR 524.1883 - Prednisolone sodium phosphate-neomycin sulfate ophthalmic ointment.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Prednisolone sodium phosphate-neomycin sulfate... DOSAGE FORM NEW ANIMAL DRUGS § 524.1883 Prednisolone sodium phosphate-neomycin sulfate ophthalmic ointment. (a) Specifications. Prednisolone sodium phosphate-neomycin sulfate ophthalmic ointment contains...

  18. 21 CFR 524.1883 - Prednisolone sodium phosphate-neomycin sulfate ophthalmic ointment.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Prednisolone sodium phosphate-neomycin sulfate... DOSAGE FORM NEW ANIMAL DRUGS § 524.1883 Prednisolone sodium phosphate-neomycin sulfate ophthalmic ointment. (a) Specifications. Prednisolone sodium phosphate-neomycin sulfate ophthalmic ointment contains...

  19. 21 CFR 524.1883 - Prednisolone sodium phosphate-neomycin sulfate ophthalmic ointment.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Prednisolone sodium phosphate-neomycin sulfate... DOSAGE FORM NEW ANIMAL DRUGS § 524.1883 Prednisolone sodium phosphate-neomycin sulfate ophthalmic ointment. (a) Specifications. Prednisolone sodium phosphate-neomycin sulfate ophthalmic ointment contains...

  20. Resistance to fluoroquinolones and methicillin in ophthalmic isolates of Staphylococcus pseudintermedius from companion animals.

    PubMed

    Kang, Min-Hee; Chae, Min-Joo; Yoon, Jang-Won; Lee, So-Young; Yoo, Jong-Hyun; Park, Hee-Myung

    2014-07-01

    Resistance to fluoroquinolones and methicillin was determined for 49 ophthalmic isolates of Staphylococcus pseudintermedius from dogs with and without ophthalmic disease. Resistance was observed for ciprofloxacin (40.8%), ofloxacin (38.8%), enrofloxacin (38.8%), levofloxacin (34.7%), and moxifloxacin (4.1%). Eighteen isolates, 16 of which were resistant to oxacillin, were mecA-positive. Nine of the 16 oxacillin-resistant mecA-positive S. pseudintermedius isolates were resistant to more than one fluoroquinolone and 2 isolates were resistant to 5 fluoroquinolones. The frequency of mecA gene occurrence and fluoroquinolone resistance was twice as high among S. pseudintermedius isolates derived from dogs with ophthalmic disease compared with isolates for dogs without ophthalmic disease. The high prevalence of methicillin and fluoroquinolone resistance in S. pseudintermedius from dogs with ophthalmic disease is a concern.