Phase 3
Completed N=859
A Study of the Safety and Efficacy of Gatifloxacin in Patients With Bacterial Conjunctivitis
Bacterial Conjunctivitis
Source: ClinicalTrials.gov NCT00518089 ↗
Enrolled (actual)
859
Serious AEs
0.2%
Results posted
Nov 2011
Primary outcomePrimary: Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge Up to Day 6 — 51.8; 41.3 Percentage of Patients
Summary
The study will determine the safety and efficacy of gatifloxacin eye drops in patients with bacterial conjunctivitis
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge Up to Day 6 |
51.8; 41.3 | — |
| SECONDARY Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6 |
59.6; 46.7 | — |
| SECONDARY Percentage of Patients With Microbiological Cure Up to Day 6 |
92.2; 80.2 | — |
| SECONDARY Percentage of Patients With Clinical Improvement of Ocular Signs Up to Day 6 |
97.0; 92.2 | — |
| SECONDARY Percentage of Patients With Clinical Improvement of Ocular Symptoms Up to Day 6 |
92.8; 88.6 | — |
Eligibility Criteria
Inclusion Criteria
- Clinically diagnosed with bacterial conjunctivitis
Exclusion Criteria
- Signs and/or symptoms of conjunctivitis for more than 96 hours
- Signs and/or symptoms suggestive of fungal, viral, or allergic conjunctivitis
- Clinical diagnosis of chlamydia in either eye
Data sourced from ClinicalTrials.gov (NCT00518089). 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.