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A Study to Evaluate the Safety and Efficacy of Gatifloxacin for the Treatment of 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 (Drug); moxifloxacin 0.5% eye drops (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Allergan

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan


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

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 Erythema and Conjunctival Discharge at Day 7

Secondary outcome:

Percentage of Patients With Microbiological Improvement

Percentage of Patients With Improvement in Ocular Signs for Lid Erythema

Percentage of Patients With Improvement in Ocular Signs for Conjunctival Discharge at Day 7


Minimum age: N/A. Maximum age: 31 Days. Gender(s): Both.


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

Locations and Contacts

Sacramento, California, United States

Whitby, Ontario, Canada

Additional Information

Starting date: June 2007
Last updated: August 17, 2011

Page last updated: August 23, 2015

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