Text Size

Cosopt Versus Xalacom

This study has been completed.
Sponsor:
Information provided by:
Pharmaceutical Research Network
ClinicalTrials.gov Identifier:
NCT00273481
First received: January 6, 2006
Last updated: November 18, 2008
Last verified: November 2008
History of Changes
  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-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided

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

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

ClinicalTrials.gov processed this record on May 23, 2013