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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00414011
First Posted: December 20, 2006
Last Update Posted: July 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Walter Reed Army Medical Center
  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 (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

  Eligibility

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00414011     History of Changes
Other Study ID Numbers: WRAMC WU # 04-2335-99e
First Submitted: December 19, 2006
First Posted: December 20, 2006
Results First Submitted: April 1, 2013
Results First Posted: June 26, 2013
Last Update Posted: July 17, 2013
Last Verified: June 2013

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

Additional relevant MeSH terms:
Moxifloxacin
Fluoroquinolones
Gatifloxacin
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
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors