The purpose of the study is to compare the effect of Polytrim Ophthalmic Solution and Moxifloxacin Ophthalmic Solution in treating your child's pink eye. Both these medications are approved by the Food and Drug Administration, for treatment of conjunctivitis. This study will investigate if both of the medications are equally good...
Date First Received: December 18, 2007
Last Updated: December 26, 2007
Verified by: University of Rochester, December 2007
Clinical Trial Phase: Phase 4 | Start Date: March 2007
Overall Status: Recruiting
Estimated Enrollment: 200
Brief Summary
Official Title: “A Single Blinded Clinical Trial Comparing Polytrim Ophthalmic Solution and Moxifloxacin Ophthalmic Solution for Treatment of Conjunctivitis.”
Condition Keyword(s):
Intervention(s):
The purpose of the study is to compare the effect of Polytrim Ophthalmic Solution and Moxifloxacin Ophthalmic Solution in treating your child's pink eye. Both these medications are approved by the Food and Drug Administration, for treatment of conjunctivitis. This study will investigate if both of the medications are equally good.
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Investigator), Active Control, Single Group Assignment
Intervention(s) in this Clinical Trial
- Drug: moxifloxacin
- 1-2 drops three times a day for 8-10 days.
- Drug: polytrim
- 1-2 drops four times a day for 8-10 days.
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- Active Comparator: 2
Outcome Measures for this Clinical Trial
Primary Measures
- Clinical Cure
- Time Frame: 10 days
Safety Issue?: No
- Time Frame: 10 days
Secondary Measures
- Microbiological cure
- Time Frame: 10 days
Safety Issue?: No
- Time Frame: 10 days
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- 1 - 18 years of age with presumed bacterial conjunctivitis.
Exclusion Criteria:
- Previous antibiotics or to receive systemic antibiotic.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 1 Year
Maximum Age for this Clinical Trial: 18 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: University of Rochester
Overall Clinical Trial Officials and Contacts
Francis Gigliotti, MD Principal Investigator University of Rochester
Overall Contact: Francis Gigliotti, MD 585-275-5944 Francis_gigliotti@urmc.rochester.edu
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00581542
Study ID Number: RSRB #17454
ClinicalTrials.gov Identifier: NCT00581542
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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