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 on December 19, 2006. No Changes Posted

Sponsor:	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:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind

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

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

Additional relevant MeSH terms:

Gatifloxacin
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 12, 2012