Effect of Topical Fluoroquinolones on Epithelial Wound Healing After PRK

This study has been completed.
Sponsor:
Information provided by:
Donnenfeld, Eric, M.D.
ClinicalTrials.gov Identifier:
NCT00569881
First received: December 6, 2007
Last updated: December 7, 2007
Last verified: December 2007
  Purpose

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.


Condition Intervention
Corneal Epithelial Wound Healing
Drug: gatifloxacin and moxifloxacin

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Effect of Gatifloxacin 0.3% and Moxifloxacin 0.5% on Epithelial Wound Healing After Photorefractive Keratectomy

Resource links provided by NLM:


Further study details as provided by Donnenfeld, Eric, M.D.:

Primary Outcome Measures:
  • Wound Healing [ Time Frame: Days after PRK ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: January 2007
Study Completion Date: March 2007
Groups/Cohorts Assigned Interventions
1
Corneal epithelial wound healing with moxifloxacin
Drug: gatifloxacin and moxifloxacin
Comparison of wound healing between drugs
Other Name: Zymar and Vigamox
2
Corneal epithelial wound healing with gatifloxacin
Drug: gatifloxacin and moxifloxacin
Comparison of wound healing between drugs
Other Name: Zymar and Vigamox

Detailed Description:

Prior generation fluoroquinolones predominantly either inhibit topoisomerase II (DNA Gyrase) or topoisomerase IV and therefore only require one genetic mutation for bacteria to develop resistance. Fourth-generation fluoroquinolones are equally effective against topoisomerase II and IV, which significantly expands their spectrum of action against gram-positive agents and atypical mycobacteria and Nocardia . This duality of action of the fourth generation fluoroquinolones requires that for bacteria to become resistant to these agents, the bacteria must undergo two genetic mutations resulting in a significantly decreased chance of an organism developing resistance.Minimum inhibitory concentrations determined in vitro suggest that fourth-generation fluoroquinolones are more effective than second- and third-generation fluoroquinolones against gram-positive bacteria including Staphylococcal species found in endophthalmitis and bacterial keratitis cultures. The increased efficacy of fourth-generation fluoroquinolones make these antibiotics important agents to evaluate for prophylaxis against post-PRK infections. This was a retrospective chart review.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00569881

Sponsors and Collaborators
Donnenfeld, Eric, M.D.
Investigators
Principal Investigator: Eric Donnenfeld, MD OCLI
  More Information

No publications provided

Responsible Party: Eric Donnenfeld, MD, Founding Partner, OCLI
ClinicalTrials.gov Identifier: NCT00569881     History of Changes
Other Study ID Numbers: Donnenfeld2
Study First Received: December 6, 2007
Last Updated: December 7, 2007
Health Authority: United States: None Needed

Keywords provided by Donnenfeld, Eric, M.D.:
Epithelium
Wound Healing
PRK

Additional relevant MeSH terms:
Gatifloxacin
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014