Effect of Topical Fluoroquinolones on Epithelial Wound Healing After PRK

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The prescribed antibiotic for prophylaxis of infection following PRK should be effective at eradicating a potential infection. In addition, the antibiotic should have a rapid onset of action, effectively penetrate the target tissue, and be safe and not toxic to any layer of the healing cornea, especially the epithelium. Several studies have investigated the toxicity of the fourth generation fluoroquinolones on the corneal epithelium and studies have demonstrated that gatifloxacin is less deleterious to the healing cornea than moxifloxacin. Most of these studies, however, have been conducted in animals. This was a retrospective chart review.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Donnenfeld, Eric, M.D.
• Treatments: Fluoroquinolones; Gatifloxacin; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

Inclusion Criteria:

• Patients were eligible for inclusion if they were a healthy male or female 18 years of age or older and were candidates for bilateral PRK.

• Eligible patients had a best-corrected Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity score equivalent to a Snellen score of 20/30 or better in each eye, had a stable prescription for 1 year, were willing to participate in the study, and were able to comprehend and sign the informed consent form.

• All subjects were instructed that if they decide not to participate they could withdraw from the study at any time.

Exclusion Criteria:

• Patients were excluded from the study if they had a history of refractive or other ocular surgery in either eye.

• Patients with any condition which could delay wound healing were not eligible to participate.

• They were excluded if they had poor tolerance to any component of the masked study fluoroquinolones, Acular® LS (Allergan) or Pred Forte® (Allergan).

• Patients were also excluded if they required the use of a systemic antibiotic during the study period, were involved in another investigational study or had participated in a study within 30 days prior to the start of this study.