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
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: 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 ImprovementPercentage of Patients With Improvement in Ocular Signs for Lid Erythema Percentage of Patients With Improvement in Ocular Signs for Conjunctival Discharge at Day 7
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
Sacramento, California, United States
Whitby, Ontario, Canada
Additional Information
Starting date: June 2007
Last updated: August 17, 2011
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