Phase 3
Completed N=578
A Study of the Safety and Efficacy of Gatifloxacin in Patients With Bacterial Conjunctivitis
Bacterial Conjunctivitis
Source: ClinicalTrials.gov NCT00509873 ↗
Enrolled (actual)
578
Serious AEs
0.2%
Results posted
Nov 2011
Primary outcomePrimary: Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6 — 74.9; 65.2 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 at Day 6 |
74.9; 65.2 | — |
| SECONDARY Percentage of Patients With Microbiological Cure at Day 6 |
89.2; 61.4 | — |
| SECONDARY Percentage of Patients With Clinical Improvement of Ocular Signs at Day 6 |
97.0; 96.2 | — |
| SECONDARY Percentage of Patients With Clinical Improvement of Ocular Symptoms at Day 6 |
85.5; 82.2 | — |
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 (NCT00509873). 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.