Effect of gatifloxacin 0.3% and moxifloxacin 0.5% ophthalmic solutions on human corneal epithelium following 2 dosing regimens
Accepted 27 April 2005.
Purpose
To determine whether gatifloxacin 0.3% ophthalmic solution or moxifloxacin 0.5% ophthalmic solutions are toxic to the corneal epithelium when used with 1 of 2 dosing regimens in healthy human eyes.
Setting
Price Vision Group, Indianapolis, Indiana, USA.
Methods
In this double-masked randomized fellow-eye comparison study, gatifloxacin 0.3% was instilled in 1 eye and moxifloxacin 0.5% in the other eye either 4 times a day for 7 days or hourly for 10 hours. Before and after dosing, all eyes were examined with a slitlamp and the cell layers in the central cornea were evaluated by confocal microscopy. Subject discomfort with study drop instillation was also assessed.
Results
There was no statistically significant increase in the incidence or severity of superficial punctuate keratitis following use of gatifloxacin 0.3% or moxifloxacin 0.5% when instilled 4 times a day for 7 days or hourly for 10 hours. Hourly use of gatifloxacin 0.3% for 10 hours resulted in a mild but statistically significant increase in conjunctival hyperemia (P = .029). Use of moxifloxacin 0.5% resulted in a small but statistically significant deterioration of the corneal epithelial surface as assessed by confocal microscopy (P = .045). The incidence of subject discomfort with study drop instillation was comparable for the 2 antibiotics (P = .67).
Conclusion
Use of ophthalmic solutions of gatifloxacin 0.3% or moxifloxacin 0.5% did not result in clinically significant epithelial toxicity in healthy human corneas after dosing regimens of 4 times a day for 7 days or hourly for 10 hours dosing regimens.
From the Cornea Research Foundation of America (M.O. Price) and Price Vision Group (F.W. Price), Indianapolis, Indiana, and Nidek Technologies America (Maclellan), Greensboro, North Carolina, USA
Reprint requests to Francis W. Price, Jr., MD, Price Vision Group, 9002 North Meridian Street, Suite 100, Indianapolis, Indiana 46260, USA.
Supported in part by an unrestricted educational grant from Allergan, Inc., and by the Cornea Research Foundation of America.
Clorissa Quillin, Laurie Potrzebowski, and Annette Cooke provided technical and logistic assistance with this clinical study.
Dr. Maclellan is employed by Nidek, which sells the Confoscan 3 confocal microscope. No other author has a financial or proprietary interest in material or method mentioned.
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