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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


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 6

Percentage of Patients With Clinical Improvement of Ocular Signs at Day 6

Percentage of Patients With Clinical Improvement of Ocular Symptoms at Day 6


Minimum age: 1 Year. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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