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Cosopt Versus Xalacom

NCT ID: NCT00273481

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

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-04-30

Brief Summary

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To compare the intraocular pressure efficacy and safety of the DTFC given twice daily versus the LTFC given once every morning following a run-in period with timolol maleate given twice daily.

Detailed Description

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Conditions

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Open-Angle Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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dorzolamide 2%/timolol maleate 0.5% fixed combination

Intervention Type DRUG

latanoprost 0.005%/timolol maleate 0.5% fixed combination

Intervention Type DRUG

timolol maleate 0.5%

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adults with primary open-angle or pigment-dispersion glaucoma, or ocular hypertension
* at baseline the intraocular pressure should be 20 to 32 mm Hg inclusive at 08:00 measurement (Visit 2) after dosing with timolol the evening before
* the intraocular pressure should be 32 mm Hg or less at all the time points in both eyes at Visit 2
* visual acuity should be 6/60 or better in the study eye(s)

Exclusion Criteria

* any anticipated change in systemic hypotensive therapy during the trial
* use of any corticosteroids by any route for more than two weeks during the study
* contraindications to study medicines
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

Cindy M. Hutnik, BSc, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Barbara Cvenkel, MD

Role: PRINCIPAL_INVESTIGATOR

University Eye Clinic Ljubljana

Locations

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Lawson Health Research Insitute

London, Ontario, Canada

Site Status

University Eye Clinic

Ljubljana, , Slovenia

Site Status

Countries

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Canada Slovenia

Other Identifiers

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PRN 05-001

Identifier Type: -

Identifier Source: org_study_id