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Timothy L. Comstock, Heleen H. DeCory, Lynne S. Gearinger, Timothy W. Morris; Clinical Efficacy of Besifloxacin Ophthalmic Suspension, 0.6% Against Less Common Conjunctivitis Pathogens of Ophthalmic Interest. Invest. Ophthalmol. Vis. Sci. 2012;53(14):4007.
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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.
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.
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.
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.
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