Effect of gatifloxacin 0.3% and moxifloxacin 0.5% ophthalmic solutions on human corneal epithelium following 2 dosing regimens.
OBJECTIVE
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.


METHODS
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).


CONCLUSIONS
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.
Price
Marianne O
MO
Cornea Research Foundation of America, Indianapolis, Indiana, USA.
Price
Francis W
FW
Maclellan
David
D
D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001372:Aza Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D019573:Epithelium, Corneal / Q000187:drug effects* / Q000473:pathology; D005260:Female; D024841:Fluoroquinolones / Q000008:administration & dosage* / Q000009:adverse effects; D000077734:Gatifloxacin; D006801:Humans; D008297:Male; D018613:Microscopy, Confocal; D008875:Middle Aged; D000077266:Moxifloxacin; D009883:Ophthalmic Solutions / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D011804:Quinolines / Q000008:administration & dosage* / Q000009:adverse effects
D000900:Anti-Bacterial Agents; D001372:Aza Compounds; D024841:Fluoroquinolones; D009883:Ophthalmic Solutions; D011804:Quinolines; D000077734:Gatifloxacin; D000077266:Moxifloxacin