Abstract
Purpose: :
The purpose of this study was to assess the clinical efficacy of besifloxacin ophthalmic suspension, 0.6% against ocular infections caused by Pseudomonas aeruginosa, Serratia marcescens, and Neiseria spp across four clinical studies of besifloxacin in the treatment of bacterial conjunctivitis.
Methods: :
Cases of bacterial conjunctivitis caused by each of these species were pooled from three bacterial conjunctivitis clinical trials evaluating besifloxacin ophthalmic suspension 0.6% administered TID for 5 days (two vehicle-controlled and one active-controlled) and one bacterial conjunctivitis trial evaluating besifloxacin administered BID for 3 days. Rates for clinical resolution and bacterial eradication in the pooled sample were summarized for each follow-up visit with the first follow-up visit occurring at or near the end of treatment and the second follow-up visit occurring on Day 7 through 9.
Results: :
There were a total of 18 patients with infections caused by these pathogens at baseline that were randomized to treatment with besifloxacin ophthalmic suspension 0.6% across the 4 studies (n=5 for P aeruginosa, n=4 for S marcescens, n=7 for Neiseria spp.). The rate of bacterial eradication was 100% at both follow-up visits for all of these patients. The rates of clinical resolution at the first and second follow up visits, respectively, were 40% (2/5) and 80% (4/5) for patients with P aeruginosa cultures at baseline, 25% (1/4) and 75% (3/4) for patients with S marcescens cultures at baseline, and 57% (4/7) and 100% (7/7) for patients with Neiserria spp. at baseline, respectively.
Conclusions: :
Treatment of patients with baseline conjunctival infections from P aeruginosa, S marcescens, and Neiseria spp. with besifloxacin ophthalmic suspension, 0.6% resulted in complete eradication of the baseline infection by the first follow-up visit (end of 3 to 5 days of treatment) and high rates of clinical resolution.
Keywords: antibiotics/antifungals/antiparasitics • bacterial disease • conjunctivitis