Phase 3
Completed N=474
Efficacy of Besifloxacin Ophthalmic Suspension in the Treatment of Bacterial Conjunctivitis
Bacterial Conjunctivitis
Source: ClinicalTrials.gov NCT00972777 ↗
Enrolled (actual)
474
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcomePrimary: Clinical Resolution — 89; 62 eyes
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Resolution |
103; 94 | — |
| PRIMARY Microbial Eradication |
115; 91 | — |
| SECONDARY Clinical Resolution |
103; 94 | — |
| SECONDARY Microbial Eradication |
115; 91 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00972777). 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. Informational only — not medical advice.