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

Tracking Information

First Received Date ^ICMJE

March 19, 2007

Last Updated Date

June 1, 2009

Start Date ^ICMJE

April 2007

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Intraocular pressure reduction
Safety profile

Change History

Complete list of historical versions of study NCT00449956 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Intraocular pressure reduction rate
Outflow pressure reduction rate

Descriptive Information

Brief Title ^ICMJE

MK0507A Clinical Study in Patients With Glaucoma and Ocular Hypertension

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Glaucoma

Intervention ^ICMJE

Drug: dorzolamide hydrochloride (+) timolol maleate
Drug: Comparator: timolol maleate
Drug: Comparator: dorzolamide hydrochloride

Study Arms / Comparison Groups

Experimental: combination of dorzolamide hydrochloride and timolol maleate
Active Comparator: Concomitant use of dorzolamide hydrochloride and timolol maleate
Active Comparator: timolol maleate

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

474

Completion Date

May 2008

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with glaucoma and ocular hypertension

Exclusion Criteria:

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

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00449956

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study ID Numbers ^ICMJE

2007_011, MK0507A-149

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP