Phase 4
N=171
A Study to Evaluate the Safety and Efficacy of Gatifloxacin for the Treatment of Bacterial Conjunctivitis
Bacterial Conjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT00464438 ↗Enrolled (actual)
171
Serious AEs
0.6%
Results posted
Sep 2011
Primary outcome: Primary: Percentage of Patients With Clearing (Clinical Success) of Conjunctival Erythema and Conjunctival Discharge at Day 7 — 78.6; 84.4 Percentage of Patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- gatifloxacin (Drug); moxifloxacin 0.5% eye drops (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Sep 2008
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 | — |
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
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.