Phase III efficacy and safety study of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis
| Autor: | Wolfgang Haas, Michael Tepedino, Michael R. Paterno, Timothy W. Morris, Dale W. Usner, Warren H. Heller, Timothy L. Comstock, Lynne Brunner |
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| Rok vydání: | 2009 |
| Předmět: |
Adult
Male medicine.medical_specialty Adolescent Treatment outcome Conjunctivitis Bacterial Young Adult Double-Blind Method Internal medicine Humans Medicine Child Trial registration Aged Aged 80 and over Bacterial Conjunctivitis business.industry Antimicrobial efficacy Besifloxacin Osmolar Concentration Outcome measures Infant Azepines Bacterial Infections General Medicine Middle Aged Anti-Bacterial Agents Surgery Treatment Outcome Ophthalmic solutions Child Preschool Female Besifloxacin Ophthalmic Suspension Ophthalmic Solutions business Fluoroquinolones medicine.drug |
| Zdroj: | Current Medical Research and Opinion. 25:1159-1169 |
| ISSN: | 1473-4877 0300-7995 |
| Popis: | To compare the clinical and antimicrobial efficacy of besifloxacin ophthalmic suspension 0.6% with that of vehicle in the treatment of bacterial conjunctivitis.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.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.NCT number, NCT00347932.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%, p0.0001, respectively) and Visit 3 (84.4% vs. 69.1%, p = 0.0011; and 88.4% vs. 71.7%, p0.0001, 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).Besifloxacin ophthalmic suspension produces clinical resolution and microbial eradication rates significantly better than vehicle and is safe for the treatment of bacterial conjunctivitis.A limitation of this study is the lack of a non-treatment control group. |
| Databáze: | OpenAIRE |
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