Phase 3
N=1,161
A Study to Investigate the Safety and Efficacy of BOL-303224 in the Treatment of Bacterial Conjunctivitis
Acute Bacterial Conjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT00348348 ↗Enrolled (actual)
1,161
Serious AEs
0.2%
Results posted
Aug 2009
Primary outcome: Primary: Clinical Resolution — 167; 147 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Besifloxacin (Drug); Moxifloxacin solution (Drug)
- Age
- Pediatric, Adult, Older Adult · 1+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Jul 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Resolution |
236; 213 | — |
| PRIMARY Microbial Eradication |
238; 220 | — |
| SECONDARY Clinical Resolution |
236; 213 | — |
| SECONDARY Microbial Eradication |
238; 220 | — |
Summary
This is a study to investigate a novel drug candidate for the treatment of bacterial conjunctivitis.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00348348). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.