Phase 4
Completed N=171
A Study to Evaluate the Safety and Efficacy of Gatifloxacin for the Treatment of Bacterial Conjunctivitis
Bacterial Conjunctivitis
Source: ClinicalTrials.gov NCT00464438 ↗
Enrolled (actual)
171
Serious AEs
0.6%
Results posted
Sep 2011
Primary outcomePrimary: Percentage of Patients With Clearing (Clinical Success) of Conjunctival Erythema and Conjunctival Discharge at Day 7 — 78.6; 84.4 Percentage of Patients
Summary
This is a 7 day study to evaluate the safety and efficacy of topical gatifloxacin ophthalmic solution for the treatment of bacterial conjunctivitis in subjects from birth to 31 days of age
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Clearing (Clinical Success) of Conjunctival Erythema and Conjunctival Discharge at Day 7 |
78.6; 84.4 | — |
| SECONDARY Percentage of Patients With Microbiological Improvement |
94.6; 92.2 | — |
| SECONDARY Percentage of Patients With Improvement in Ocular Signs for Lid Erythema |
76.8; 75.0 | — |
| SECONDARY Percentage of Patients With Improvement in Ocular Signs for Conjunctival Discharge at Day 7 |
94.6; 92.2 | — |
Eligibility Criteria
Inclusion Criteria
- diagnosed with bacterial conjunctivitis
Exclusion Criteria
- chemical or foreign body trauma to either eye
- infection in either eye (besides bacterial conjunctivitis)
- white spots in the cornea or ulcers in either eye
- clinical diagnosis of chlamydia or gonorrhea in either eye
Data sourced from ClinicalTrials.gov (NCT00464438). 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.