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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:


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

Estimated Enrollment: 40
  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