- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00569881
Effect of Topical Fluoroquinolones on Epithelial Wound Healing After PRK
December 7, 2007 updated by: Donnenfeld, Eric, M.D.
Effect of Gatifloxacin 0.3% and Moxifloxacin 0.5% on Epithelial Wound Healing After Photorefractive Keratectomy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
22
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients presented to the practice of a cornea trained ophthalmic consultant.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
Corneal epithelial wound healing with moxifloxacin
|
Comparison of wound healing between drugs
Other Names:
|
2
Corneal epithelial wound healing with gatifloxacin
|
Comparison of wound healing between drugs
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Wound Healing
Time Frame: Days after PRK
|
Days after PRK
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eric Donnenfeld, MD, OCLI
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Study Completion (Actual)
March 1, 2007
Study Registration Dates
First Submitted
December 6, 2007
First Submitted That Met QC Criteria
December 7, 2007
First Posted (Estimate)
December 10, 2007
Study Record Updates
Last Update Posted (Estimate)
December 10, 2007
Last Update Submitted That Met QC Criteria
December 7, 2007
Last Verified
December 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Donnenfeld2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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