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

Drug Information available for: 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
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

Study ID Numbers:	PRN 05-017
Study First Received:	January 6, 2006
Last Updated:	November 18, 2008
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 January 16, 2009