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)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2005-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Topical Fluoroquinolones on Epithelial Wound Healing After PRK

NCT00569881

Corneal Epithelial Wound Healing

COMPLETED

Prospective Randomized Comparison of Zymar(Gatifloxacin) and Vigamox (Moxifloxacin) in Killing Conjunctival Bacterial Flora Following a One-hour Application

NCT00466570

Conjunctical Flora

WITHDRAWN NA

Effect of Moxifloxacin Versus Gatifloxacin on Corneal Epithelium Following Pterygium Excision

NCT00892918

Primary Pterygium

UNKNOWN NA

Effectiveness and Safety of 0.5% Moxifloxacin Hydrochloride Ophthalmic Solution in Perioperative Sterilization in Patients Undergoing Ophthalmic Surgery

NCT05413980

Post Operative Endophthalmitis

COMPLETED

Efficacy of Moxifloxacin/Prednisolone in Prevention of Post Surgery Inflammation

NCT01603030

Eye Infection/Inflammation Other

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Epithelium, Corneal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Moxifloxacin

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

Group Type EXPERIMENTAL

Moxifloxacin

Intervention Type DRUG

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

Gatifloxacin

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

Group Type EXPERIMENTAL

Gatifloxacin

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Moxifloxacin

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

Intervention Type DRUG

Gatifloxacin

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes