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)

Epithelium, Corneal Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00414011
• Other study ID #: WRAMC WU # 04-2335-99e
• Status: Completed
• Phase: N/A
• First received: December 19, 2006
• Last updated: June 26, 2013
• Est. completion date: February 2005

Study information

• Verified date: June 2013
• Source: Walter Reed Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2005
• Est. primary completion date: February 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epithelium, Corneal

Intervention

Drug:
• Moxifloxacin
1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
• Gatifloxacin
1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery

Locations

Country	Name	City	State
United States	Walter Reed Army Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Walter Reed Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal Epithelial Healing Time	patients' eyes will be observed daily after surgery until the corneal epithelium has completely healed (usually 3 to 4 days)	3 to 4 days after surgery	No