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)

Not Applicable

Completed

• Conditions: Epithelium, Corneal
• Interventions: Drug: Gatifloxacin; Drug: Moxifloxacin

• Registration Number: NCT00414011
• Lead Sponsor: Walter Reed Army Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Primary Completion: 2005-02
• Study Completion: 2005-02
• Study First Submitted: 2006-12-19
• Study First Submitted QC: 2006-12-19
• Study First Posted: 2006-12-20
• Results First Submitted: 2013-04-01
• Results First Submitted QC: 2013-05-17
• Status Verified: 2013-06
• Results First Posted: 2013-06-26
• Last Update Submitted: 2013-06-26
• Last Update Posted: 2013-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gatifloxacin	Gatifloxacin	Gatifloxacin eyedrops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
Moxifloxacin	Moxifloxacin	Moxifloxacin eye drops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery

Primary Outcome Measures

Name	Time	Method
Corneal Epithelial Healing Time	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)

Trial Locations

Locations (1)

Walter Reed Army Medical Center; 🇺🇸 Washington, District of Columbia, United States