Effect of Topical Fluoroquinolones on Epithelial Wound Healing After PRK
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| First Received Date ICMJE | December 6, 2007 | ||||
| Last Updated Date | December 7, 2007 | ||||
| Start Date ICMJE | January 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Wound Healing [ Time Frame: Days after PRK ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00569881 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Topical Fluoroquinolones on Epithelial Wound Healing After PRK | ||||
| Official Title ICMJE | Effect of Gatifloxacin 0.3% and Moxifloxacin 0.5% on Epithelial Wound Healing After Photorefractive Keratectomy | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients presented to the practice of a cornea trained ophthalmic consultant. |
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| Condition ICMJE | Corneal Epithelial Wound Healing | ||||
| Intervention ICMJE | Drug: gatifloxacin and moxifloxacin
Comparison of wound healing between drugs
Other Name: Zymar and Vigamox |
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 22 | ||||
| Completion Date | March 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00569881 | ||||
| Other Study ID Numbers ICMJE | Donnenfeld2 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Eric Donnenfeld, MD, Founding Partner, OCLI | ||||
| Study Sponsor ICMJE | Donnenfeld, Eric, M.D. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Donnenfeld, Eric, M.D. | ||||
| Verification Date | December 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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