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OpenTrials
Completed

NCT Number: NCT00392275

Penetrance of Third Generation Fluoroquinolones in Eyes With Functioning Filtering Blebs

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Indiana University Hospital, Indianapolis, Indiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ofloxacin 0.3%

Drug

Ciprofloxacin 0.3%

Drug

Levofloxacin 0.5%

Drug

Ofloxacin 400mg

Drug

Ciprofloxacin 400mg

Drug

Levofloxacin 250mg

Drug

Primary outcomes

  1. Aqueous levels of antibiotics

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start
2002
Study completion
2006
First posted
Oct 25, 2006
Registry last updated
Apr 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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