Penetrance of Third Generation Fluoroquinolones in Eyes With Functioning Filtering Blebs

NCT ID: NCT00392275

Last Updated: 2013-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2006-05-31

Brief Summary

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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

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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.

Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Ofloxacin 0.3%

Intervention Type DRUG

Ciprofloxacin 0.3%

Intervention Type DRUG

Levofloxacin 0.5%

Intervention Type DRUG

Ofloxacin 400mg

Intervention Type DRUG

Ciprofloxacin 400mg

Intervention Type DRUG

Levofloxacin 250mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All patients with functioning filtering blebs will be evaluated prospectively for inclusion

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indiana University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Louis B Cantor, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

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Indiana University Hospital

Indianapolis, Indiana, United States

Site Status

Richard L Rodeboush VA Medical Center

Indianapolis, Indiana, United States

Site Status

Wishard Memorial Hospital

Indianapolis, Indiana, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 11545629 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18211932 (View on PubMed)

Other Identifiers

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0208-29

Identifier Type: -

Identifier Source: org_study_id

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