MK0507A Clinical Study in Patients With Glaucoma and Ocular Hypertension - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00449956

Purpose

The clinical study compares safety and efficacy of MK0507A (dorzolamide 1.0% / timolol 0.5%) with 1) timolol 0.5% and with 2) concomitant therapy with dorzolamide 1.0% / timolol 0.5% in patients with glaucoma and ocular hypertension.

Condition	Intervention	Phase
Glaucoma	Drug: dorzolamide hydrochloride (+) timolol maleate Drug: Comparator: timolol maleate Drug: Comparator: dorzolamide hydrochloride	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Multicenter, Double-Blind, Active Comparator-controlled Study to Evaluate the Safety and Efficacy of MK0507A in Patients With Glaucoma and Ocular Hypertension Who Are Inadequately Controlled on Beta-Blockers

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 Merck:

Primary Outcome Measures:

Change in Intraocular Pressure (IOP) From Baseline at 8 Weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent Change From Baseline in Intraocular Pressure (IOP) at 8 Weeks [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
Percent Change From Baseline in Outflow Pressure Reduction Rate at 8 Weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment:	474
Study Start Date:	April 2007
Study Completion Date:	May 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental combination of dorzolamide hydrochloride and timolol maleate	Drug: dorzolamide hydrochloride (+) timolol maleate Dorzolamide hydrochloride 1% + timolol 0.5%, 8-week
2: Active Comparator Concomitant use of dorzolamide hydrochloride and timolol maleate	Drug: Comparator: timolol maleate timolol maleate 0.5%, 8-week Drug: Comparator: dorzolamide hydrochloride dorzolamide hydrochloride 1%, 8-week
3: Active Comparator timolol maleate	Drug: Comparator: timolol maleate timolol maleate 0.5%, 8-week

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with glaucoma and ocular hypertension

Exclusion Criteria:

History of ocular surgery within 3 months
Administration contradiction to timolol and dorzolamide

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00449956

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

PhRMA Clinical Study Results Database - web-based repository for clinical study results This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_011, MK0507A-149
Study First Received:	March 19, 2007
Results First Received:	January 23, 2009
Last Updated:	November 6, 2009
ClinicalTrials.gov Identifier:	NCT00449956 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Eye Diseases
Physiological Effects of Drugs
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Carbonic Anhydrase Inhibitors

Glaucoma
Maleic acid
Therapeutic Uses
Adrenergic beta-Antagonists
Cardiovascular Diseases
Adrenergic Antagonists
Anti-Arrhythmia Agents
Timolol
Hypertension
Ocular Hypertension
Dorzolamide

ClinicalTrials.gov processed this record on November 25, 2009