ABSTRACT
PURPOSE: To evaluate the efficacy and safety of gatifloxacin 0.5% ophthalmic solution administered twice daily for treatment of acute bacterial conjunctivitis. METHODS: Two identically designed, double-masked, multicenter studies in the United States and India enrolled patients 1 year or older with acute bacterial conjunctivitis. Patients were randomized to gatifloxacin 0.5% or vehicle treatment for 5 days. Clinical success in clearing conjunctival hyperemia and discharge at day 6 (primary endpoint) and day 4 and microbiological cure were determined. Isolates from positive conjunctival samples were tested for sensitivity and susceptibility. Safety measures included adverse events (AEs). Data from these 2 studies were pooled for these analyses. RESULTS: Of the 1437 randomized patients, 658 constituted the modified intent-to-treat population. Patient characteristics were similar between the pooled treatment groups. Clinical success occurred for 58.0% of gatifloxacin 0.5%-treated versus 45.5% vehicle-treated patients at day 6 (P=0.001) and for 23.7% versus 15.4% in the respective groups at day 4 (P=0.007). Microbiological cure was higher with gatifloxacin 0.5% than vehicle at days 4 and 6 (P<0.001 for both time points). The combined minimum inhibitory concentration required to inhibit 90% of isolates for gatifloxacin 0.5% was 2.0 µg/mL for gram-positive and gram-negative organisms. AEs were reported by 11.6% and 13.3% of patients in the gatifloxacin 0.5% and vehicle safety populations, respectively. One patient in each treatment group experienced a serious AE; neither was treatment related. CONCLUSIONS: The 0.5% concentration of gatifloxacin ophthalmic solution was safe and effective for treatment of acute bacterial conjunctivitis with twice-daily administration for 5 days.
