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Lumigan Versus Cosopt

This study has been completed.

Sponsored by: Pharmaceutical Research Network
Information provided by: Pharmaceutical Research Network
ClinicalTrials.gov Identifier: NCT00273455
  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 IV

Genetics Home Reference related topics:   early-onset glaucoma   

MedlinePlus related topics:   Glaucoma   

ChemIDplus related topics:   Dorzolamide    Dorzolamide hydrochloride    Bimatoprost    Timolol    Timolol maleate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment

Further study details as provided by Pharmaceutical Research Network:

Estimated Enrollment:   34
Study Start Date:   January 2006

  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

Study ID Numbers:   PRN 05-017
First Received:   January 6, 2006
Last Updated:   March 30, 2007
ClinicalTrials.gov Identifier:   NCT00273455
Health Authority:   United States: Institutional Review Board

Study placed in the following topic categories:
Bimatoprost
Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Timolol
Dorzolamide
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Carbonic Anhydrase Inhibitors
Therapeutic Uses
Adrenergic beta-Antagonists
Adrenergic Antagonists
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on August 28, 2008




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