Penetrance of Third Generation Fluoroquinolones in Eyes With Functioning Filtering Blebs

This study has been completed.

First Received on October 23, 2006. Last Updated on December 21, 2007 History of Changes

Sponsor:	Indiana University School of Medicine
Information provided by:	Indiana University
ClinicalTrials.gov Identifier:	NCT00392275

Purpose

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.

Condition	Intervention	Phase
Cataract	Drug: Ofloxacin 0.3% Drug: Ciprofloxacin 0.3% Drug: Levofloxacin 0.5% Drug: Ofloxacin 400mg Drug: Ciprofloxacin 400mg Drug: Levofloxacin 250mg	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment
Official Title:	Penetrance of Third Generation Fluoroquinolones in Eyes With Functioning Filtering Blebs

Resource links provided by NLM:

MedlinePlus related topics: Cataract

Drug Information available for: Ofloxacin Ciprofloxacin Ciprofloxacin hydrochloride Ciprofloxacin lactate Levofloxacin Ofloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Indiana University:

Primary Outcome Measures:

Aqueous levels of antibiotics

Estimated Enrollment:	48
Study Start Date:	November 2002
Study Completion Date:	May 2006

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00392275

Locations

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

Sponsors and Collaborators

Indiana University School of Medicine

Investigators

Principal Investigator:

Louis B Cantor, MD

Indiana University

More Information

Publications:

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2008 Jan 22.

ClinicalTrials.gov Identifier:	NCT00392275 History of Changes
Other Study ID Numbers:	0208-29
Study First Received:	October 23, 2006
Last Updated:	December 21, 2007
Health Authority:	United States: Institutional Review Board

Keywords provided by Indiana University:

Cataract
Aqueous absorption
Funtioning Filtering Blebs

Additional relevant MeSH terms:

Blister
Cataract
Skin Diseases, Vesiculobullous
Skin Diseases
Pathological Conditions, Anatomical
Lens Diseases
Eye Diseases
Ciprofloxacin
Ofloxacin
Fluoroquinolones

Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Anti-Bacterial Agents
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on February 09, 2012