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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)

W

Walter Reed Army Medical Center

Status

Completed

Conditions

Epithelium, Corneal

Treatments

Drug: Moxifloxacin
Drug: Gatifloxacin

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00414011
WRAMC WU # 04-2335-99e

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

Moxifloxacin
Experimental group
Description:
Moxifloxacin eye drops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
Treatment:
Drug: Moxifloxacin
Gatifloxacin
Experimental group
Description:
Gatifloxacin eyedrops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
Treatment:
Drug: Gatifloxacin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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