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N/A Completed N=40 Randomized Double-blind Treatment

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
Source: ClinicalTrials.gov NCT00414011 ↗
Enrolled (actual)
40
Serious AEs
—
Results posted
Jun 2013
Primary outcomePrimary: Corneal Epithelial Healing Time — 4; 4 days to complete epithelial healing

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Corneal Epithelial Healing Time
4; 4 —

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00414011). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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