A Study to Evaluate the Safety and Efficacy of Gatifloxacin for the Treatment of Bacterial Conjunctivitis
Information source: Allergan
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bacterial Conjunctivitis
Intervention: gatifloxacin 0.3% eye drops (Drug); moxifloxacin 0.5% eye drops (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Allergan Overall contact:
Allergan Inc, Email: clinicaltrials@allergan.com
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
Clinical Details
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Proportion of patients with clearing of conjunctival erythema and conjunctival discharge
Secondary outcome: Microbiological improvementImprovement in ocular signs Improvement in ocular symptoms
Eligibility
Minimum age: N/A.
Maximum age: 31 Days.
Gender(s): Both.
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
Locations and Contacts
Allergan Inc, Email: clinicaltrials@allergan.com
Mexico D.F., Mexico; Not yet recruiting
Sacramento, California, United States; Recruiting
Whitby, Ontario, Canada; Not yet recruiting
Additional Information
Starting date: June 2007
Ending date: June 2009
Last updated: May 5, 2008
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