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Lumigan Versus Cosopt

This study has been completed.
Sponsor:
Information provided by:
Pharmaceutical Research Network
ClinicalTrials.gov Identifier:
NCT00273455
First received: January 6, 2006
Last updated: November 18, 2008
Last verified: November 2008
History of Changes
  Purpose

To compare the intraocular pressure effect and safety of the dorzolamide/timolol fixed combination given twice daily versus bimatoprost given once every evening in patients with open-angle glaucoma in patients insufficiently controlled on latanoprost monotherapy


Condition Intervention Phase
Open-Angle Glaucoma
 Drug: bimatoprost 0.03%
Drug: dorzolamide 2%/timolol maleate 0.5% fixed combination
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:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by Pharmaceutical Research Network:

Estimated Enrollment: 34
Study Start Date: January 2006
Study Completion Date: May 2007
  Eligibility

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

Inclusion Criteria:

  • adults with a diagnosis of bilateral open-angle glaucoma including: primary, pigment dispersion or exfoliation in both eyes
  • on no therapy the intraocular pressure should be 22-29 mm Hg inclusive at the 8:00 AM measurement
  • visual acuity should be 20/200 or better in each eye

Exclusion Criteria:

  • historical failure to respond to topical beta-blockers in a clinically meaningful manner
  • any contraindication to study medications
  • any anticipated change, or modification in the 6 weeks prior to Visit 1, in systemic hypertensive therapy during the trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00273455

Locations
United States, Kentucky
Taustine Eye Center
Louisville, Kentucky, United States, 40217
United States, South Carolina
Glaucoma Consultants & Center for Eye Research, PA
Mt. Pleasant, South Carolina, United States, 29464
United States, Texas
Houston Eye Associates
Houston, Texas, United States, 77025
Sponsors and Collaborators
Pharmaceutical Research Network
Investigators
Study Director: William C. Stewart, MD Pharmaceutical Research Network, LLC
Principal Investigator: Robert D. Williams, MD Taustine Eye Center
Principal Investigator: Robert H. Stewart, MD Houston Eye Associates
Principal Investigator: Elizabeth D. Sharpe, MD Glaucoma Consultants & Center for Eye Research, PA
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00273455     History of Changes
Other Study ID Numbers: PRN 05-017
Study First Received: January 6, 2006
Last Updated: November 18, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Timolol
Dorzolamide
Bimatoprost
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 21, 2013