Assessing Cosopt Switch Patients

This study has been completed.

First Received: January 6, 2006 Last Updated: November 18, 2008 History of Changes

Sponsored by:	Pharmaceutical Research Network
Information provided by:	Pharmaceutical Research Network
ClinicalTrials.gov Identifier:	NCT00273442

Purpose

To assess the safety and efficacy of a cohort of patients switched to the dorzolamide/timolol maleate fixed combination because they are insufficiently controlled on latanoprost monotherapy.

Condition	Intervention	Phase
Ocular Hypertension Open-Angle Glaucoma Exfoliation Syndrome Glaucoma, Pigmentary	Drug: timolol maleate Drug: dorzolamide/timolol maleate fixed combination	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Timolol Timolol maleate Dorzolamide Dorzolamide hydrochloride

U.S. FDA Resources

Further study details as provided by Pharmaceutical Research Network:

Estimated Enrollment:	60
Study Start Date:	November 2005
Study Completion Date:	April 2007

Eligibility

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

Criteria

Inclusion Criteria:

adults with clinical diagnosis of POAG, pigment-dispersion or exfoliation glaucoma or ocular hypertension
the IOP on latanoprost must be 31 mm Hg or less in both eyes, and 21 to 31 mm Hg inclusive in at least one eye at 08:00 AM
visual acuity should be 20/200 or better in each eye

Exclusion Criteria:

contraindications to study drugs
anticipated change in systemic hypotensive therapy during the trial
use of any corticosteroids by any route in the three months immediately prior to Visit 2

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00273442

Locations

United States, Arkansas
Little Rock Eye Clinic
Little Rock, Arkansas, United States, 72205
United States, Georgia
Omni Eye Services
Atlanta, Georgia, United States, 30342
United States, Illinois
Midwest Eye Center
Bourbonnais, Illinois, United States, 60914
United States, Oklahoma
Mark J. Weiss, MD
Tulsa, Oklahoma, United States, 74104
United States, South Carolina
Glaucoma Consultants & Center for Eye Research
Mt. Pleasant, South Carolina, United States, 29464

Sponsors and Collaborators

Pharmaceutical Research Network

Investigators

Study Director:	William C. Stewart, MD	Pharmaceutical Research Network, LLC
Principal Investigator:	Mark J. Weiss, MD	Unaffiliated
Principal Investigator:	Douglas G. Day, MD	Omni Eye Services
Principal Investigator:	Sriram Sonty, MD, FACS	Midwest Eye Center
Principal Investigator:	J. Charles Henry, MD	Little Rock Eye Clinic
Principal Investigator:	Elizabeth D. Sharpe, MD	Glaucoma Consultants & Center for Eye Research

More Information

No publications provided

Study ID Numbers:	PRN 05-007
Study First Received:	January 6, 2006
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00273442 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Neurotransmitter Agents
Uveal Diseases
Adrenergic Agents
Eye Diseases
Vascular Diseases
Exfoliation Syndrome
Cardiovascular Agents
Antihypertensive Agents
Carbonic Anhydrase Inhibitors

Glaucoma
Glaucoma, Open-Angle
Adrenergic beta-Antagonists
Adrenergic Antagonists
Anti-Arrhythmia Agents
Timolol
Ocular Hypertension
Hypertension
Dorzolamide

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Pathologic Processes
Glaucoma
Syndrome
Glaucoma, Open-Angle
Therapeutic Uses
Adrenergic beta-Antagonists
Cardiovascular Diseases
Timolol
Anti-Arrhythmia Agents
Uveal Diseases

Disease
Eye Diseases
Vascular Diseases
Exfoliation Syndrome
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Carbonic Anhydrase Inhibitors
Iris Diseases
Adrenergic Antagonists
Ocular Hypertension
Hypertension
Dorzolamide

ClinicalTrials.gov processed this record on September 01, 2009