A Study of the Safety and Efficacy of Gatifloxacin in Patients With Bacterial Conjunctivitis
Information source: Allergan
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bacterial Conjunctivitis
Intervention: Gatifloxacin 0.5% eye drops (Drug); placebo eye drops (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Allergan Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan
Summary
The study will determine the safety and efficacy of gatifloxacin eye drops in patients with
bacterial conjunctivitis
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6
Secondary outcome: Percentage of Patients With Microbiological Cure at Day 6Percentage of Patients With Clinical Improvement of Ocular Signs at Day 6 Percentage of Patients With Clinical Improvement of Ocular Symptoms at Day 6
Eligibility
Minimum age: 1 Year.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Gretna, Louisiana, United States
Additional Information
Starting date: August 2007
Last updated: October 24, 2011
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