Moxifloxacin vs. Polytrim for Conjunctivitis

This study is currently recruiting participants.

Verified August 2011 by University of Rochester

First Received on December 18, 2007. Last Updated on August 11, 2011 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	A Single Blinded Clinical Trial Comparing Polytrim Ophthalmic Solution and Moxifloxacin Ophthalmic Solution for Treatment of Conjunctivitis.

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye

Drug Information available for: Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

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 2012
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1	Drug: moxifloxacin 1-2 drops three times a day for 8-10 days.
Active Comparator: 2	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:	Francis Gigliotti, MD, University of Rochester
ClinicalTrials.gov Identifier:	NCT00581542 History of Changes
Other Study ID Numbers:	RSRB #17454
Study First Received:	December 18, 2007
Last Updated:	August 11, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Conjunctivitis
Conjunctival Diseases
Eye Diseases
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses

Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012