Prashant Garg1, Umang Mathur, Parul Sony, Radhika Tandon, Timothy W Morris, Timothy L Comstock. 1. From the *L. V. Prasad Eye Institute, Hyderabad; †Dr Shroff's Charity Eye Centre, Delhi; ‡Shroff Eye Centre, Gurgaon, Haryana; and §Dr R. P. Centre for Ophthalmic Sciences, AIIMS, New Delhi, India; and ¶Medical Affairs, Bausch + Lomb, Rochester, NY and ∥R&D Microbiology and Sterilization Sciences.
Abstract
PURPOSE: To evaluate the efficacy of besifloxacin ophthalmic suspension 0.6% compared with moxifloxacin ophthalmic solution 0.5% in the treatment of bacterial conjunctivitis in an Indian population. DESIGN: Multicenter, randomized, double-masked, active-controlled, parallel-group, clinical trial, including 6 clinical sites in India. METHODS: Patients were randomized to receive 1 drop of besifloxacin or moxifloxacin in the infected eye(s), 3 times daily, for 5 days. Primary efficacy end points included clinical resolution and bacterial eradication at day 5. Secondary efficacy end points included clinical resolution and bacterial eradication at day 8, ocular discharge, bulbar conjunctival injection, investigator's global assessment, and bacterial eradication by species. Efficacy was analyzed using the Cochran-Mantel-Haenszel and Pearson χ2 tests. Safety was assessed by the incidence of ocular and nonocular treatment-emergent adverse events (AEs), changes in visual acuity, and biomicroscopy and ophthalmoscopy findings. Data presented are that for the subset of patients from India. RESULTS: Of the 123 patients randomized at clinical sites in India, 96.7% completed the study. Day 5 differences in microbial eradication (100% besifloxacin vs 96.3% moxifloxacin) and in clinical resolution (78.9% besifloxacin vs 71.4% moxifloxacin) were not statistically significant. No statistically significant between-group differences were observed for secondary end points. All ocular AEs in both groups were mild or moderate in severity. There were no drug-related ocular AEs with besifloxacin. CONCLUSIONS: Treatment of bacterial conjunctivitis with besifloxacin 0.6% produces similar antibacterial and clinical efficacy as that with moxifloxacin 0.5% in an Indian population, with no clinically meaningful safety concerns.
RCT Entities:
PURPOSE: To evaluate the efficacy of besifloxacin ophthalmic suspension 0.6% compared with moxifloxacin ophthalmic solution 0.5% in the treatment of bacterial conjunctivitis in an Indian population. DESIGN: Multicenter, randomized, double-masked, active-controlled, parallel-group, clinical trial, including 6 clinical sites in India. METHODS:Patients were randomized to receive 1 drop of besifloxacin or moxifloxacin in the infected eye(s), 3 times daily, for 5 days. Primary efficacy end points included clinical resolution and bacterial eradication at day 5. Secondary efficacy end points included clinical resolution and bacterial eradication at day 8, ocular discharge, bulbar conjunctival injection, investigator's global assessment, and bacterial eradication by species. Efficacy was analyzed using the Cochran-Mantel-Haenszel and Pearson χ2 tests. Safety was assessed by the incidence of ocular and nonocular treatment-emergent adverse events (AEs), changes in visual acuity, and biomicroscopy and ophthalmoscopy findings. Data presented are that for the subset of patients from India. RESULTS: Of the 123 patients randomized at clinical sites in India, 96.7% completed the study. Day 5 differences in microbial eradication (100% besifloxacin vs 96.3% moxifloxacin) and in clinical resolution (78.9% besifloxacin vs 71.4% moxifloxacin) were not statistically significant. No statistically significant between-group differences were observed for secondary end points. All ocular AEs in both groups were mild or moderate in severity. There were no drug-related ocular AEs with besifloxacin. CONCLUSIONS: Treatment of bacterial conjunctivitis with besifloxacin 0.6% produces similar antibacterial and clinical efficacy as that with moxifloxacin 0.5% in an Indian population, with no clinically meaningful safety concerns.