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Lumigan Versus Cosopt

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ClinicalTrials.gov Identifier: NCT00273455
Recruitment Status : Completed
First Posted : January 9, 2006
Last Update Posted : November 19, 2008
Sponsor:
Information provided by:
Pharmaceutical Research Network

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Open-Angle Glaucoma Drug: bimatoprost 0.03% Drug: dorzolamide 2%/timolol maleate 0.5% fixed combination Drug: placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : January 2006
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Bimatoprost

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00273455


Locations
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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
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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
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ClinicalTrials.gov Identifier: NCT00273455    
Other Study ID Numbers: PRN 05-017
First Posted: January 9, 2006    Key Record Dates
Last Update Posted: November 19, 2008
Last Verified: November 2008
Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Glaucoma
Ocular Hypertension
Eye Diseases
Timolol
Bimatoprost
Dorzolamide
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Carbonic Anhydrase Inhibitors