A randomized, investigator- masked clinical trial comparing the efficacy and safety of gatifloxacin 0.3% administered BID versus QID for the treatment BID versus QID for the treatment of acute bacterial conjunctivitis of acute bacterial conjunctivitis.

ABSTRACTPurpose: To compare the efficacy and safety of gatifloxacin ophthalmic solution 0.3% (Zymar) administered BID versus QID in patients with acute bacterial conjunctivitis.Methods: In a randomized, investigator-masked clinical trial, patients diagnosed with bacterial conjunctivitis (based on signs and symptoms) received gatifloxacin either BID or QID for 5 days. Visits were scheduled at day 0, day 3, and day 5. Conjunctival cultures were taken at each visit. The clinical cure rate at day 5 was determined for the entire patient population (primary endpoint). Additionally, clinical cure at day 5 was evaluated for a population of patients defined a priori (per protocol) as being culture positive at baseline and with no substantial protocol deviations. Safety was determined through recording of adverse events. Minimal inhibitory concentrations (MIC) and susceptibility of isolates to gatifloxacin were determined using a broth dilution method. * Zymar is a registered trade name of Allergan, Inc, Irvine, CA...