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)

This study has been completed.
Sponsor:
Information provided by:
Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00414011
First received: December 19, 2006
Last updated: June 26, 2013
Last verified: June 2013

December 19, 2006
June 26, 2013
Not Provided
February 2005   (final data collection date for primary outcome measure)
Corneal Epithelial Healing Time [ Time Frame: 3 to 4 days after surgery ] [ Designated as safety issue: No ]
patients' eyes will be observed daily after surgery until the corneal epithelium has completely healed (usually 3 to 4 days)
Not Provided
Complete list of historical versions of study NCT00414011 on ClinicalTrials.gov Archive Site
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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)
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Epithelium, Corneal
  • Drug: Moxifloxacin
    1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
  • Drug: Gatifloxacin
    1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
  • Experimental: Moxifloxacin
    Moxifloxacin eye drops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
    Intervention: Drug: Moxifloxacin
  • Experimental: Gatifloxacin
    Gatifloxacin eyedrops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
    Intervention: Drug: Gatifloxacin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
February 2005
February 2005   (final data collection date for primary outcome measure)

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
Both
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00414011
WRAMC WU # 04-2335-99e
Not Provided
Not Provided
Walter Reed Army Medical Center
Not Provided
Principal Investigator: KRAIG S. BOWER, MD Walter Reed Army Medical Center
Walter Reed Army Medical Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP