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Cosopt Versus Xalacom

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00273481
First Posted: January 9, 2006
Last Update Posted: November 19, 2008
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.
Information provided by:
Pharmaceutical Research Network
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Pharmaceutical Research Network:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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

ClinicalTrials.gov Identifier: NCT00273481     History of Changes
Other Study ID Numbers: PRN 05-001
First Submitted: January 6, 2006
First Posted: January 9, 2006
Last Update Posted: November 19, 2008
Last Verified: November 2008

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Glaucoma
Eye Diseases
Timolol
Latanoprost
Dorzolamide
Maleic acid
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Enzyme Inhibitors
Carbonic Anhydrase Inhibitors