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Penetrance of Third Generation Fluoroquinolones in Eyes With Functioning Filtering Blebs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00392275
Recruitment Status : Completed
First Posted : October 25, 2006
Last Update Posted : April 10, 2013
Sponsor:
Information provided by (Responsible Party):
Indiana University ( 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.

Condition or disease Intervention/treatment Phase
Cataract Drug: Ofloxacin 0.3% Drug: Ciprofloxacin 0.3% Drug: Levofloxacin 0.5% Drug: Ofloxacin 400mg Drug: Ciprofloxacin 400mg Drug: Levofloxacin 250mg Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Penetrance of Third Generation Fluoroquinolones in Eyes With Functioning Filtering Blebs
Study Start Date : November 2002
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract




Primary Outcome Measures :
  1. Aqueous levels of antibiotics


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00392275


Locations
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United States, Indiana
Indiana University Hospital
Indianapolis, Indiana, United States, 46202
Richard L Rodeboush VA Medical Center
Indianapolis, Indiana, United States, 46202
Wishard Memorial Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Investigators
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Principal Investigator: Louis B Cantor, MD Indiana University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT00392275    
Other Study ID Numbers: 0208-29
First Posted: October 25, 2006    Key Record Dates
Last Update Posted: April 10, 2013
Last Verified: December 2007
Keywords provided by Indiana University ( Indiana University School of Medicine ):
Cataract
Aqueous absorption
Funtioning Filtering Blebs
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases
Ciprofloxacin
Levofloxacin
Ofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Infective Agents, Urinary
Renal Agents