A Study to Investigate the Safety and Efficacy of BOL-303224 in the Treatment of Bacterial Conjunctivitis
Phase 3
Completed
- Conditions
- Acute Bacterial Conjunctivitis
- Interventions
- Registration Number
- NCT00348348
- Lead Sponsor
- Bausch & Lomb Incorporated
- Brief Summary
This is a study to investigate a novel drug candidate for the treatment of bacterial conjunctivitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1161
Inclusion Criteria
- Clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye.
Exclusion Criteria
- Pregnant or nursing females.
- Use of any antibiotic within 72 hours of enrollment.
- Any disease conditions that could interfere with the safety and efficacy evaluations of the study drug.
- Participation in an ophthalmic drug or device research study within 30 days prior to entry into this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Moxifloxacin solution Moxifloxacin solution Moxifloxacin hydrochloride ophthalmic solution 0.5% Besifloxacin Suspension Besifloxacin Besifloxacin hydrochloride ophthalmic suspension 0.6%
- Primary Outcome Measures
Name Time Method Microbial Eradication Day 5 (+/- 1 day) eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated
Clinical Resolution Day 5(+/- 1 day) Resolution of conjunctival discharge and bulbar conjunctival injection. (mITT, culture confirmed, as treated)
- Secondary Outcome Measures
Name Time Method Microbial Eradication Day 8 or Day 9 Microbial eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated
Clinical Resolution Day 8 or Day 9 Clinical resolution of conjunctival discharge and bulbar conjunctival injection, modified intent to treat (mITT), culture confirmed, as treated