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

Baseline Characteristics

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).

Baseline Measures

	MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)	Timolol 0.5%	Concomitant (Dorzolamide 1.0% / Timolol 0.5%)	Total
Number of Participants [units: participants]	189	92	193	474
Age [units: Years] Mean ± Standard Deviation	63.2 ± 10.8	61.3 ± 11.6	62.3 ± 12.7	62.4 ± 11.7
Age, Customized [units: participants]
<65 years	92	50	102	244
>=65 years	97	42	91	230
Gender [units: participants]
Female	104	43	98	245
Male	85	49	95	229
Diagnosis [units: participants]
Open-angle glaucoma	107	51	90	248
Normal-tension glaucoma	8	6	4	18
Ocular hypertension	74	35	99	208
Intraocular pressure (IOP) at Hour 2 [units: mmHg] Mean ± Standard Deviation	20.54 ± 2.07	20.23 ± 1.85	20.38 ± 2.31	20.42 ± 2.13

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