Efficacy of Besifloxacin Ophthalmic Suspension in the Treatment of Bacterial Conjunctivitis

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is being conducted to evaluate the clinical and microbial efficacy of besifloxacin ophthalmic suspension compared with vehicle in the treatment of bacterial conjunctivitis. This study was conducted as a phase IIb study and continued with further enrollment as a phase III study.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch & Lomb Incorporated
• Treatments: 7-(3-aminohexahydro-1H-azepin-1-yl)-8-chloro-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid; Besifloxacin; Fluoroquinolones

Criteria

Inclusion Criteria:

• Subjects who are at least one year of age.

• Subjects who have a clinical diagnosis of acute bacterial conjunctivitis.

• Subjects who are willing to discontinue contact lens wear for the duration of the study.

Exclusion Criteria:

• Subjects who have any uncontrolled systemic disease or debilitating disease.

• Subjects with known sensitivity or contraindications to besifloxacin, fluoroquinolones or any ingredients in study drugs.

• Subjects who are expected to require treatment with any disallowed medications.