Comparison of the Effect of 4th Generation Fluoroquinolones, Gatifloxacin and Moxifloxacin, on Epithelial Healing Following Photorefractive Keratectomy (PRK), A Substudy of: Initial Evaluation of Excimer Laser Keratorefractive Surgery in U.S. Army Personnel (WU # 2335-99)

This study has been completed.

First Received: December 19, 2006 No Changes Posted

Sponsored by:	Walter Reed Army Medical Center
Information provided by:	Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:	NCT00414011

Purpose

The purpose of this study is a prospective,double-blinded, randomized trial to compare the rate of healing following PRK after the use of two commercially available 4th generation fluoroquinolones, moxifloxacin and gatifloxacin.

Condition	Intervention
Epithelium, Corneal	Drug: Moxifloxacin Drug: Gatifloxacin

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Uncontrolled, Parallel Assignment

Resource links provided by NLM:

Drug Information available for: Gatifloxacin Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Walter Reed Army Medical Center:

Estimated Enrollment:

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Manifest refraction spherical equivalent (MSE) of up to -6.00 diopters (D) at the spectacle plane with refractive cylinder up to 3.00D.

Exclusion Criteria:

Concurrent topical or systemic medications that may impair healing including corticosteroids, antimetabolites, isotretinoin, amiodarone hydrochloride and/ or sumatripin.
Patients with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.
Anterior basement membrane dystrophy.
History of recurrent epithelial erosion.
Significant dry eye (symptomatic sith Schirmer <5mm at 5 minutes)
Other corneal epithelial disorder or healing abnormality

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414011

Locations

United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307

Sponsors and Collaborators

Walter Reed Army Medical Center

Investigators

Principal Investigator:

KRAIG S. BOWER, MD

Walter Reed Army Medical Center

More Information

No publications provided

Study ID Numbers:	WRAMC WU # 04-2335-99e
Study First Received:	December 19, 2006
Last Updated:	December 19, 2006
ClinicalTrials.gov Identifier:	NCT00414011 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Walter Reed Army Medical Center:

Removal of corneal epithelium followed by excimer laser treatment during prk

Study placed in the following topic categories:

Fluoroquinolones
Moxifloxacin
Gatifloxacin

Additional relevant MeSH terms:

Anti-Infective Agents
Moxifloxacin
Therapeutic Uses
Pharmacologic Actions
Gatifloxacin

ClinicalTrials.gov processed this record on July 06, 2009