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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.
Information provided by:
Walter Reed Army Medical Center Identifier:
First received: December 19, 2006
Last updated: June 26, 2013
Last verified: June 2013
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 (Participant, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Corneal Epithelial Healing Time [ Time Frame: 3 to 4 days after surgery ]
    patients' eyes will be observed daily after surgery until the corneal epithelium has completely healed (usually 3 to 4 days)

Enrollment: 40
Study Completion Date: February 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Moxifloxacin
Moxifloxacin eye drops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
Drug: Moxifloxacin
1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
Experimental: Gatifloxacin
Gatifloxacin eyedrops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
Drug: Gatifloxacin
1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00414011

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
Principal Investigator: KRAIG S. BOWER, MD Walter Reed Army Medical Center
  More Information Identifier: NCT00414011     History of Changes
Other Study ID Numbers: WRAMC WU # 04-2335-99e
Study First Received: December 19, 2006
Results First Received: April 1, 2013
Last Updated: June 26, 2013

Keywords provided by Walter Reed Army Medical Center:
Removal of corneal epithelium followed by excimer laser treatment during prk

Additional relevant MeSH terms:
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Nucleic Acid Synthesis Inhibitors
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs processed this record on May 25, 2017