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V. Prajna, R. Vajpayee, S. Trocme, W.F. Davitt, III, H. Jensen, R. Liu, E. Safyan; Safety and Efficacy of Gatifloxacin 0.3% as Compared With Ciprofloxacin 0.3% for the Treatment of Acute Bacterial Corneal Ulcers . Invest. Ophthalmol. Vis. Sci. 2006;47(13):1916.
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Gatifloxacin is a fourth generation fluoroquinolone antibiotic with a broad spectrum of activity against both gram–positive and gram–negative organisms. This study evaluated the safety and efficacy of gatifloxacin 0.3% as compared with ciprofloxacin 0.3% (chosen as the comparator due to its established efficacy for gram–negative infections) in the treatment of acute bacterial corneal ulcers.
In this multicenter, investigator–masked study, patients with acute bacterial corneal ulcers (>1 mm diameter) in one eye were randomized to receive gatifloxacin 0.3% (n=37) or ciprofloxacin 0.3% (n=38). Day 0 dosing was 1 drop every 5 min for 30 minutes, followed by 1 drop every 30 minutes while awake and 1 drop every 2 hours after retiring. Day 1 dosing was 1 drop every hour while awake and 1 drop every 4 hours after retiring. Dosing was 1 drop every 2 hours while awake for days 2–6 and 1 drop QID while awake for days 7 to 21 (or up to Day 28, if the ulcer was healing). Dosing was terminated when re–epithelialization was complete or on day 28 (whichever occurred sooner). The primary efficacy analysis was based on patients with positive bacterial cultures (modified intent–to–treat population).
The percentage of patients reaching complete re–epithelialization was higher in the gatifloxacin group than the ciprofloxacin group at day 11 [81.1% (30/37) vs 52.6% (20/38), (P=.009)], day 14 [86.5% (32/37) vs 60.5% (23/38), (P=.011)], and day 21 [89.2% (33/37) vs 76.3% (29/38), (P=.141)]. A significantly greater percentage of patients in the gatifloxacin group were rated as cured in the investigator’s evaluation at day 14 (P=.032). There was no statistically significant difference between the two treatment groups in change from baseline in the area of epithelial healing (at any time during the study) or in the rate of adverse events. Both treatments were well–tolerated.
Gatifloxacin 0.3% is safe and effective in the treatment of acute bacterial corneal ulcers. Patients with acute bacterial ulcers treated with gatifloxacin 0.3% were observed to have complete healing at earlier follow–up visits than did those treated with ciprofloxacin 0.3%.
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