Cosopt Versus Xalacom

This study has been completed.

Sponsored by:	Pharmaceutical Research Network
Information provided by:	Pharmaceutical Research Network
ClinicalTrials.gov Identifier:	NCT00273481

Purpose

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.

Condition	Intervention	Phase
Open-Angle Glaucoma Ocular Hypertension	Drug: dorzolamide 2%/timolol maleate 0.5% fixed combination Drug: latanoprost 0.005%/timolol maleate 0.5% fixed combination Drug: timolol maleate 0.5% Drug: placebo	Phase IV

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Latanoprost Dorzolamide Dorzolamide hydrochloride Timolol Timolol maleate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment

Further study details as provided by Pharmaceutical Research Network:

Estimated Enrollment:	33
Study Start Date:	September 2005
Study Completion Date:	April 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00273481

Locations

Canada, Ontario
Lawson Health Research Insitute
London, Ontario, Canada, N6A 4G5
Slovenia
University Eye Clinic
Ljubljana, Slovenia, A525

Sponsors and Collaborators

Pharmaceutical Research Network

Investigators

Study Director:	William C. Stewart, MD	Pharmaceutical Research Network, LLC
Principal Investigator:	Cindy M. Hutnik, BSc, PhD, MD	Lawson Health Research Institute
Principal Investigator:	Barbara Cvenkel, MD	University Eye Clinic Ljubljana

More Information

Study ID Numbers:	PRN 05-001
Study First Received:	January 6, 2006
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00273481
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Maleic acid
Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Vascular Diseases

Timolol
Latanoprost
Dorzolamide
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents

Pharmacologic Actions
Carbonic Anhydrase Inhibitors
Therapeutic Uses
Adrenergic beta-Antagonists
Cardiovascular Diseases
Adrenergic Antagonists
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on January 16, 2009