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Cosopt Versus Xalatan

This study has been completed.
Sponsor:
Information provided by:
Pharmaceutical Research Network
ClinicalTrials.gov Identifier:
NCT00273429
First received: January 6, 2006
Last updated: January 8, 2007
Last verified: January 2007
History of Changes
  Purpose

To compare the 24-hour efficacy and safety, measured every three hours, of the dorzolamide/timolol fixed combination given twice daily versus latanoprost and placebo each given once daily.


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

Study Start Date: April 2005
Estimated Study Completion Date: December 2005
  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, pigmentary, or exfoliation glaucoma, or ocular hypertenstion
  • intraocular pressure should be 22 to 30 mm Hg inclusive on timolol BID at the 08:00 H
  • ETDRS visual acuity must be 1.0 or better in both eyes

Exclusion Criteria:

  • any contraindications to study medications
  • any anticipated change in systemic hypertensive therapy during the trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00273429

Locations
United States, Florida
Central Florida Eye Associates
Lakeland, Florida, United States, 33805
United States, Illinois
Midwest Eye Center SC
Bourbonnais, Illinois, United States, 60914
Sponsors and Collaborators
Pharmaceutical Research Network
Investigators
Study Director: William C. Stewart, MD Pharmaceutical Research Network, LLC
Principal Investigator: Jay Mulaney, MD Central Florida Eye Associates
Principal Investigator: Sriram Sonty, MD, FACS Midwest Eye Center SC
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00273429     History of Changes
Other Study ID Numbers: PRN 04-015
Study First Received: January 6, 2006
Last Updated: January 8, 2007
Health Authority: United States: Institutional Review Board

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 16, 2013