OBJECTIVE: To compare the clinical and antimicrobial efficacy of besifloxacin ophthalmic suspension 0.6% with that of vehicle in the treatment of bacterial conjunctivitis. RESEARCH DESIGN AND METHODS: This was a randomized, multicenter, double-masked, vehicle-controlled study. A total of 957 patients aged 1 year and older with bacterial conjunctivitis were randomized to treatment with besifloxacin ophthalmic suspension 0.6% or vehicle applied topically three times daily for 5 days. MAIN OUTCOME MEASURES: Primary endpoints were clinical resolution and microbial eradication of baseline bacterial infection at Visit 2 (Day 5 +/- 1). Secondary endpoints included clinical resolution and microbial eradication at Visit 3 (Day 8 or 9), individual clinical outcomes at follow-up visits, and safety. CLINICAL TRIAL REGISTRATION: NCT number, NCT00347932. RESULTS:Three hundred and ninety patients had culture-confirmed bacterial conjunctivitis. Clinical resolution and microbial eradication were significantly greater with besifloxacin ophthalmic suspension than with vehicle at Visit 2 (45.2% vs. 33.0%, p = 0.0084; and 91.5% vs. 59.7%, p < 0.0001, respectively) and Visit 3 (84.4% vs. 69.1%, p = 0.0011; and 88.4% vs. 71.7%, p < 0.0001, respectively). Results for secondary endpoints of individual clinical outcomes were consistent with primary endpoints. Fewer eyes receiving besifloxacin ophthalmic suspension experienced adverse events than those receiving vehicle (9.2% vs. 13.9%; p = 0.0047). CONCLUSIONS:Besifloxacin ophthalmic suspension produces clinical resolution and microbial eradication rates significantly better than vehicle and is safe for the treatment of bacterial conjunctivitis. LIMITATIONS: A limitation of this study is the lack of a non-treatment control group.
RCT Entities:
OBJECTIVE: To compare the clinical and antimicrobial efficacy of besifloxacin ophthalmic suspension 0.6% with that of vehicle in the treatment of bacterial conjunctivitis. RESEARCH DESIGN AND METHODS: This was a randomized, multicenter, double-masked, vehicle-controlled study. A total of 957 patients aged 1 year and older with bacterial conjunctivitis were randomized to treatment with besifloxacin ophthalmic suspension 0.6% or vehicle applied topically three times daily for 5 days. MAIN OUTCOME MEASURES: Primary endpoints were clinical resolution and microbial eradication of baseline bacterial infection at Visit 2 (Day 5 +/- 1). Secondary endpoints included clinical resolution and microbial eradication at Visit 3 (Day 8 or 9), individual clinical outcomes at follow-up visits, and safety. CLINICAL TRIAL REGISTRATION: NCT number, NCT00347932. RESULTS: Three hundred and ninety patients had culture-confirmed bacterial conjunctivitis. Clinical resolution and microbial eradication were significantly greater with besifloxacin ophthalmic suspension than with vehicle at Visit 2 (45.2% vs. 33.0%, p = 0.0084; and 91.5% vs. 59.7%, p < 0.0001, respectively) and Visit 3 (84.4% vs. 69.1%, p = 0.0011; and 88.4% vs. 71.7%, p < 0.0001, respectively). Results for secondary endpoints of individual clinical outcomes were consistent with primary endpoints. Fewer eyes receiving besifloxacin ophthalmic suspension experienced adverse events than those receiving vehicle (9.2% vs. 13.9%; p = 0.0047). CONCLUSIONS:Besifloxacin ophthalmic suspension produces clinical resolution and microbial eradication rates significantly better than vehicle and is safe for the treatment of bacterial conjunctivitis. LIMITATIONS: A limitation of this study is the lack of a non-treatment control group.
Authors: Jesse DeLeon; Bruce E Silverstein; Catherine Allaire; Lynne S Gearinger; Kirk M Bateman; Timothy W Morris; Timothy L Comstock Journal: Clin Drug Investig Date: 2012-05-01 Impact factor: 2.859
Authors: Wolfgang Haas; Chris M Pillar; Christine K Hesje; Christine M Sanfilippo; Timothy W Morris Journal: J Antimicrob Chemother Date: 2010-04-30 Impact factor: 5.790