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Lumigan Versus Cosopt

NCT ID: NCT00273455

Last Updated: 2008-11-19

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

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-05-31

Brief Summary

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To compare the intraocular pressure effect and safety of the dorzolamide/timolol fixed combination given twice daily versus bimatoprost given once every evening in patients with open-angle glaucoma in patients insufficiently controlled on latanoprost monotherapy

Detailed Description

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Conditions

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Open-Angle Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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bimatoprost 0.03%

Intervention Type DRUG

dorzolamide 2%/timolol maleate 0.5% fixed combination

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adults with a diagnosis of bilateral open-angle glaucoma including: primary, pigment dispersion or exfoliation in both eyes
* on no therapy the intraocular pressure should be 22-29 mm Hg inclusive at the 8:00 AM measurement
* visual acuity should be 20/200 or better in each eye

Exclusion Criteria

* historical failure to respond to topical beta-blockers in a clinically meaningful manner
* any contraindication to study medications
* any anticipated change, or modification in the 6 weeks prior to Visit 1, in systemic hypertensive therapy during the trial
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pharmaceutical Research Network

OTHER

Sponsor Role lead

Principal Investigators

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William C. Stewart, MD

Role: STUDY_DIRECTOR

Pharmaceutical Research Network, LLC

Robert D. Williams, MD

Role: PRINCIPAL_INVESTIGATOR

Taustine Eye Center

Robert H. Stewart, MD

Role: PRINCIPAL_INVESTIGATOR

Houston Eye Associates

Elizabeth D. Sharpe, MD

Role: PRINCIPAL_INVESTIGATOR

Glaucoma Consultants & Center for Eye Research, PA

Locations

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Taustine Eye Center

Louisville, Kentucky, United States

Site Status

Glaucoma Consultants & Center for Eye Research, PA

Mt. Pleasant, South Carolina, United States

Site Status

Houston Eye Associates

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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PRN 05-017

Identifier Type: -

Identifier Source: org_study_id