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...
Date First Received: December 19, 2006
Last Updated: December 19, 2006
Verified by: Walter Reed Army Medical Center, December 2006
Clinical Trial Phase: N/A | Start Date:
Overall Status: Completed
Estimated Enrollment: 40
Brief Summary
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Randomized, Double-Blind, Uncontrolled, Parallel Assignment
Intervention(s) in this Clinical Trial
- Drug: Moxifloxacin
- Drug: Gatifloxacin
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 21 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Walter Reed Army Medical Center
Overall Clinical Trial Officials and Contacts
KRAIG S. BOWER, MD Principal Investigator Walter Reed Army Medical Center
Additional Information
Information obtained from ClinicalTrials.gov on August 28, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00414011
Study ID Number: WRAMC WU # 04-2335-99e
ClinicalTrials.gov Identifier: NCT00414011
Health Authority: United States: Federal Government
Clinical Trials Authorship and Review
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