MK0507A Phase III Double-Blind, Comparative Study - Full Text View

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

Genetics Home Reference related topics:

early-onset glaucoma

MedlinePlus related topics:

Glaucoma High Blood Pressure

ChemIDplus related topics:

Dorzolamide Dorzolamide hydrochloride Timolol Timolol maleate

U.S. FDA Resources

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

Further study details as provided by Merck:

Primary Outcome Measures:

Intraocular pressure reduction [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
Safety profile [ Time Frame: 8 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Intraocular pressure reduction rate [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
Outflow pressure reduction rate [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]

Enrollment:	450
Study Start Date:	March 2007
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

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

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_011, MK0507A-149
First Received:	March 19, 2007
Last Updated:	March 5, 2008
ClinicalTrials.gov Identifier:	NCT00449956
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:

Maleic acid

Glaucoma

Eye Diseases

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 October 07, 2008

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