MK0507A Clinical Study in Patients With Glaucoma and Ocular Hypertension (0507A-149)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Glaucoma

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00449956

MK0507A-149

2007_011

0507A-149

Details and patient eligibility

About

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.

Enrollment: 474 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with glaucoma and ocular hypertension

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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474 participants in 3 patient groups

1

Experimental group

Description:

combination of dorzolamide hydrochloride and timolol maleate

Treatment:

Drug: dorzolamide hydrochloride (+) timolol maleate

2

Active Comparator group

Description:

Concomitant use of dorzolamide hydrochloride and timolol maleate

Treatment:

Drug: Comparator: dorzolamide hydrochloride

Drug: Comparator: timolol maleate

3

Active Comparator group

Description:

timolol maleate

Treatment:

Drug: Comparator: timolol maleate