search
Back to results

Penetrance of Third Generation Fluoroquinolones in Eyes With Functioning Filtering Blebs

Primary Purpose

Cataract

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ofloxacin 0.3%
Ciprofloxacin 0.3%
Levofloxacin 0.5%
Ofloxacin 400mg
Ciprofloxacin 400mg
Levofloxacin 250mg
Sponsored by
Indiana University School of Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Cataract, Aqueous absorption, Funtioning Filtering Blebs

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Indiana University Hospital
  • Richard L Rodeboush VA Medical Center
  • Wishard Memorial Hospital

Outcomes

Primary Outcome Measures

Aqueous levels of antibiotics

Secondary Outcome Measures

Full Information

First Posted
October 23, 2006
Last Updated
April 8, 2013
Sponsor
Indiana University School of Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT00392275
Brief Title
Penetrance of Third Generation Fluoroquinolones in Eyes With Functioning Filtering Blebs
Official Title
Penetrance of Third Generation Fluoroquinolones in Eyes With Functioning Filtering Blebs
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University School of Medicine

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract, Aqueous absorption, Funtioning Filtering Blebs

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
48 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ofloxacin 0.3%
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin 0.3%
Intervention Type
Drug
Intervention Name(s)
Levofloxacin 0.5%
Intervention Type
Drug
Intervention Name(s)
Ofloxacin 400mg
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin 400mg
Intervention Type
Drug
Intervention Name(s)
Levofloxacin 250mg
Primary Outcome Measure Information:
Title
Aqueous levels of antibiotics

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis B Cantor, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Richard L Rodeboush VA Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Wishard Memorial Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11545629
Citation
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. doi: 10.1001/archopht.119.9.1254.
Results Reference
background
PubMed Identifier
18211932
Citation
Cantor LB, WuDunn D, Yung CW, Valluri S, Catoira YP, Hoop JS, Morgan LS. Ocular penetration of levofloxacin, ofloxacin and ciprofloxacin in eyes with functioning filtering blebs: investigator masked, randomised clinical trial. Br J Ophthalmol. 2008 Mar;92(3):345-7. doi: 10.1136/bjo.2007.121541. Epub 2008 Jan 22.
Results Reference
derived

Learn more about this trial

Penetrance of Third Generation Fluoroquinolones in Eyes With Functioning Filtering Blebs

We'll reach out to this number within 24 hrs