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...
Date First Received: April 19, 2007
Last Updated: May 5, 2008
Verified by: Allergan, May 2008
Clinical Trial Phase: Phase 4 | Start Date: June 2007
Overall Status: Recruiting
Estimated Enrollment: 240
Brief Summary
Condition Keyword(s):
Intervention(s):
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
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Study Primary Completion Date: June 2009
Intervention(s) in this Clinical Trial
- Drug: gatifloxacin 0.3% eye drops
- 1 drop 3 times per day through Day 6
- Drug: moxifloxacin 0.5% eye drops
- 1 drop 3 times per day through Day 6
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Active Comparator: 2
Outcome Measures for this Clinical Trial
Primary Measures
- Proportion of patients with clearing of conjunctival erythema and conjunctival discharge
- Time Frame: Day 7
Safety Issue?: No
- Time Frame: Day 7
Secondary Measures
- Microbiological improvement
- Time Frame: Day 7
Safety Issue?: No
- Time Frame: Day 7
- Improvement in ocular signs
- Time Frame: Days 1- 7
Safety Issue?: No
- Time Frame: Days 1- 7
- Improvement in ocular symptoms
- Time Frame: Days 1- 7
Safety Issue?: No
- Time Frame: Days 1- 7
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: 31 Days
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Allergan
Overall Clinical Trial Officials and Contacts
Overall Contact: Allergan Inc clinicaltrials@allergan.com
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00464438
Study ID Number: 198782-003
ClinicalTrials.gov Identifier: NCT00464438
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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