Moxifloxacin vs. Polytrim for Conjunctivitis

This study is currently recruiting participants.

Verified by University of Rochester, December 2007

First Received: December 18, 2007 Last Updated: December 26, 2007 History of Changes

Sponsored by:	University of Rochester
Information provided by:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00581542

Purpose

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.

Condition	Intervention	Phase
Conjunctivitis	Drug: moxifloxacin Drug: polytrim	Phase IV

MedlinePlus related topics: Pinkeye

Drug Information available for: Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Active Control, Single Group Assignment
Official Title:	A Single Blinded Clinical Trial Comparing Polytrim Ophthalmic Solution and Moxifloxacin Ophthalmic Solution for Treatment of Conjunctivitis.

Further study details as provided by University of Rochester:

Primary Outcome Measures:

Clinical Cure [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Microbiological cure [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	March 2007
Estimated Study Completion Date:	March 2009

Arms	Assigned Interventions
1: Active Comparator	Drug: moxifloxacin 1-2 drops three times a day for 8-10 days.
2: Active Comparator	Drug: polytrim 1-2 drops four times a day for 8-10 days.

Eligibility

Ages Eligible for Study:	1 Year to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1 - 18 years of age with presumed bacterial conjunctivitis.

Exclusion Criteria:

Previous antibiotics or to receive systemic antibiotic.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00581542

Contacts

Contact: Francis Gigliotti, MD	585-275-5944	Francis_gigliotti@urmc.rochester.edu
Contact: Barbra L Murante, RN	585-275-1549	Barbra_murante@urmc.rochester.edu

Locations

United States, New York
University of Rochester	Recruiting
Rochester, New York, United States, 14642

Sponsors and Collaborators

University of Rochester

Investigators

Principal Investigator:

Francis Gigliotti, MD

University of Rochester

More Information

No publications provided

Responsible Party:	University of Rochester ( Francis Gigliotti, MD )
Study ID Numbers:	RSRB #17454
Study First Received:	December 18, 2007
Last Updated:	December 26, 2007
ClinicalTrials.gov Identifier:	NCT00581542 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Moxifloxacin
Eye Diseases
Conjunctivitis
Conjunctival Diseases

Additional relevant MeSH terms:

Anti-Infective Agents
Moxifloxacin
Therapeutic Uses
Eye Diseases

Conjunctivitis
Pharmacologic Actions
Conjunctival Diseases

ClinicalTrials.gov processed this record on May 07, 2009