NCT00392275CompletedPhase 4
Penetrance of Third Generation Fluoroquinolones in Eyes With Functioning Filtering Blebs
Indiana University School of Medicine6 sites in 1 country48 target enrollmentStarted: November 2002Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 48
- Locations
- 6
- Primary Endpoint
- Aqueous levels of antibiotics
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Aqueous levels of antibiotics
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (6)
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