Penetrance of Third Generation Fluoroquinolones in Eyes With Functioning Filtering Blebs

Phase 4

Completed

• Conditions: Cataract

• Registration Number: NCT00392275
• Lead Sponsor: Indiana University School of Medicine

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 Timeline

• Study Start: 2002-11
• Study Completion: 2006-05
• Study First Submitted: 2006-10-23
• Study First Submitted QC: 2006-10-24
• Study First Posted: 2006-10-25
• Status Verified: 2007-12
• Last Update Submitted: 2013-04-08
• Last Update Posted: 2013-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Aqueous levels of antibiotics

Trial Locations

Locations (3)

Richard L Rodeboush VA Medical Center; 🇺🇸 Indianapolis, Indiana, United States

Indiana University Hospital; 🇺🇸 Indianapolis, Indiana, United States

Wishard Memorial Hospital; 🇺🇸 Indianapolis, Indiana, United States