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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.

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

Drug Information available for:   Moxifloxacin    Moxifloxacin hydrochloride    Gatifloxacin   

U.S. FDA Resources

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

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


Study ID Numbers:   WRAMC WU # 04-2335-99e
First Received:   December 19, 2006
Last Updated:   December 19, 2006
ClinicalTrials.gov Identifier:   NCT00414011
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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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