Based on previous results with eyes without filtering blebs, the aqueous concentrations of ofloxacin and levofloxacin will exceed the concentration of ciprofloxacin after either topical or topical plus oral administration...
Date First Received: October 23, 2006
Last Updated: December 21, 2007
Verified by: Indiana University, December 2007
Clinical Trial Phase: Phase 4 | Start Date: November 2002
Overall Status: Completed
Estimated Enrollment: 48
Brief Summary
Official Title: “Penetrance of Third Generation Fluoroquinolones in Eyes With Functioning Filtering Blebs”
Condition Keyword(s):
Based on previous results with eyes without filtering blebs, the aqueous concentrations of ofloxacin and levofloxacin will exceed the concentration of ciprofloxacin after either topical or topical plus oral administration.
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Bio-availability Study
Detailed Clinical Trial Description
The purpose of this study is to assay human aqueous for concentrations of ofloxacin, ciprofloxacin and levofloxacin after topical or combined topical and oral administration in eyes with filtering blebs.
Intervention(s) in this Clinical Trial
- Drug: Ofloxacin 0.3%
- Drug: Ciprofloxacin 0.3%
- Drug: Levofloxacin 0.5%
- Drug: Ofloxacin 400mg
- Drug: Ciprofloxacin 400mg
- Drug: Levofloxacin 250mg
Outcome Measures for this Clinical Trial
Primary Measures
- Aqueous levels of antibiotics
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- All patients with functioning filtering blebs will be evaluated prospectively for inclusion
Exclusion Criteria:
- Any subject who is already scheduled to have cataract surgery performed will qualify for participation with the exception of the following exclusion criteria:
- Ongoing ocular inflammatory disease
- Bleb leakage - determined by Seidel test
- Suspected infection
- Known contraindications to use of any of these study medications.
- Pregnancy
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Indiana University School of Medicine
Overall Clinical Trial Officials and Contacts
Louis B Cantor, MD Principal Investigator Indiana University
Related Publications
References
Cantor LB, Donnenfeld E, Katz LJ, Gee WL, Finley CD, Lakhani VK, Hoop J, Flarty K. Penetration of ofloxacin and ciprofloxacin into the aqueous humor of eyes with functioning filtering blebs: a randomized trial. Arch Ophthalmol. 2001 Sep;119(9):1254-7.
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00392275
Study ID Number: 0208-29
ClinicalTrials.gov Identifier: NCT00392275
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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