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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 23, 2014