Effect of Topical Fluoroquinolones on Epithelial Wound Healing After PRK

NCT00569881 | Completed DMC

• 1 other identifier: Donnenfeld2
• Study Type: observational
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Corneal Epithelial Wound Healing

Keywords

Epithelium; Wound Healing; PRK

Outcome Measures

Primary Outcomes (1)

• Wound Healing

  Days after PRK

Study Arms (2)

1

Corneal epithelial wound healing with moxifloxacin

Drug: gatifloxacin and moxifloxacin

2

Corneal epithelial wound healing with gatifloxacin

Drug: gatifloxacin and moxifloxacin

Interventions

gatifloxacin and moxifloxacin DRUG

Comparison of wound healing between drugs

Also known as: Zymar and Vigamox

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presented to the practice of a cornea trained ophthalmic consultant.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Donnenfeld, Eric, M.D.: lead

MeSH Terms

Interventions

Gatifloxacin; Moxifloxacin

Intervention Hierarchy (Ancestors)

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

Study Officials

• Eric Donnenfeld, MD

  OCLI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: December 6, 2007
• First Posted: December 10, 2007
• Study Start: January 1, 2007
• Study Completion: March 1, 2007
• Last Updated: December 10, 2007

Record last verified: 2007-12