Moxifloxacin vs. Polytrim for Conjunctivitis

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):

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

Secondary Measures

  • Microbiological cure
    • Time Frame: 10 days
      Safety Issue?: No

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

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