Penetrance of Third Generation Fluoroquinolones in Eyes With Functioning Filtering Blebs

April 8, 2013 updated by: Indiana University School of Medicine
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

48

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Hospital
      • Indianapolis, Indiana, United States, 46202
        • Wishard Memorial Hospital
      • Indianapolis, Indiana, United States, 46202
        • Richard L Rodeboush VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Aqueous levels of antibiotics

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University School of Medicine

Investigators

  • Principal Investigator: Louis B Cantor, MD, Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

October 23, 2006

First Submitted That Met QC Criteria

October 24, 2006

First Posted (Estimate)

October 25, 2006

Study Record Updates

Last Update Posted (Estimate)

April 10, 2013

Last Update Submitted That Met QC Criteria

April 8, 2013

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0208-29

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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