MK0507A Clinical Study in Patients With Glaucoma and Ocular Hypertension

This study has been completed.

Study NCT00449956 Information provided by Merck

First Received: March 19, 2007 Last Updated: November 6, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment
Condition:	Glaucoma
Interventions:	Drug: dorzolamide hydrochloride (+) timolol maleate Drug: Comparator: timolol maleate Drug: Comparator: dorzolamide hydrochloride

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Phase III. Studied period: April 9, 2007 (date study therapy started for the first subject) to February 16, 2008 (the last subject’s last visit stipulated in study protocol). Study was conducted at 67 clinical sites.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Outpatients with primary open angle glaucoma (broad definition) and/or ocular hypertension received 4-week timolol 0.5% monotherapy in the wash-out period before the study randomization.

Reporting Groups

	Description
MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)	MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
Timolol 0.5%	Timolol 0.5%, one drop per dose twice daily to the study eye.
Concomitant (Dorzolamide 1.0% / Timolol 0.5%)	Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).

Participant Flow: Overall Study

	MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)	Timolol 0.5%	Concomitant (Dorzolamide 1.0% / Timolol 0.5%)
STARTED	189	92	193
COMPLETED	179	88	184
NOT COMPLETED	10	4	9
Adverse Event	7	1	6
Lack of Efficacy	0	0	1
Protocol Violation	1	1	1
Withdrawal by Subject	0	1	0
Physician Decision	2	1	1

Baseline Characteristics

Outcome Measures

1. Primary:

Change in Intraocular Pressure (IOP) From Baseline at 8 Weeks [ 8 weeks ]

Show Outcome Measure 1

2. Secondary:

Percent Change From Baseline in Intraocular Pressure (IOP) at 8 Weeks [ 8 Weeks ]

Show Outcome Measure 2

3. Secondary:

Percent Change From Baseline in Outflow Pressure Reduction Rate at 8 Weeks [ 8 weeks ]

Show Outcome Measure 3

Serious Adverse Events

Other Adverse Events

More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Senior Vice President, Clinical and Quantitative Sciences
Organization: Merck & Co., Inc.
phone: 1-800-672-6372

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