Penetrance of Third Generation Fluoroquinolones in Eyes With Functioning Filtering Blebs
Information source: Indiana University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cataract
Intervention: Ofloxacin 0.3% (Drug); Ciprofloxacin 0.3% (Drug); Levofloxacin 0.5% (Drug); Ofloxacin 400mg (Drug); Ciprofloxacin 400mg (Drug); Levofloxacin 250mg (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Indiana University School of Medicine Official(s) and/or principal investigator(s):
Louis B Cantor, MD, Principal Investigator, Affiliation: Indiana University
Summary
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.
Clinical Details
Official title: Penetrance of Third Generation Fluoroquinolones in Eyes With Functioning Filtering Blebs
Study design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Bio-availability Study
Primary outcome: Aqueous levels of antibiotics
Detailed 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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Indiana University Hospital, Indianapolis, Indiana 46202, United States
Wishard Memorial Hospital, Indianapolis, Indiana 46202, United States
Richard L Rodeboush VA Medical Center, Indianapolis, Indiana 46202, United States
Additional Information
Related publications: 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.
Starting date: November 2002
Ending date: May 2006
Last updated: December 21, 2007
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