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)

NCT00414011 | Completed Results

• 1 other identifier: WRAMC WU # 04-2335-99e
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epithelium, Corneal

Keywords

Removal of corneal epithelium followed by excimer laser treatment during prk

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Moxifloxacin

EXPERIMENTAL

Moxifloxacin eye drops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery

Drug: Moxifloxacin

Gatifloxacin

EXPERIMENTAL

Gatifloxacin eyedrops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery

Drug: Gatifloxacin

Interventions

Moxifloxacin DRUG

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

Moxifloxacin

Gatifloxacin DRUG

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

Gatifloxacin

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Manifest refraction spherical equivalent (MSE) of up to -6.00 diopters (D) at the spectacle plane with refractive cylinder up to 3.00D.

You may not qualify if:

• 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

Sponsors & Collaborators

• Walter Reed Army Medical Center: lead

Study Sites (1)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

Location

MeSH Terms

Interventions

Moxifloxacin; Gatifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Principal Investigator
• Organization: U.S. Army Warfighter Refractive Surgery Research Center

rose.sia@us.army.mil

571-231-1600

Study Officials

• KRAIG S. BOWER, MD

  Walter Reed Army Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: December 19, 2006
• First Posted: December 20, 2006
• Primary Completion: February 1, 2005
• Study Completion: February 1, 2005
• Last Updated: July 17, 2013
• Results First Posted: June 26, 2013

Record last verified: 2013-06

Locations

US (1)