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

Merck Sharp & Dohme LLC474 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

474

Conditions

Glaucoma

Interventions

dorzolamide hydrochloride (+) timolol maleateDRUG

Dorzolamide hydrochloride 1% + timolol 0.5%, 8-week

Comparator: timolol maleateDRUG

timolol maleate 0.5%, 8-week

Comparator: dorzolamide hydrochlorideDRUG

dorzolamide hydrochloride 1%, 8-week

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with glaucoma and ocular hypertension Exclusion Criteria: * History of ocular surgery within 3 months * Administration contradiction to timolol and dorzolamide

Outcomes

Primary Outcomes

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

Change from baseline to 8 weeks in Intraocular Pressure (IOP) assessed 2 hours after ocular instillation (at Hour 2)

Time frame: 8 weeks

Secondary Outcomes

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

Percent Change from baseline to 8 weeks in Intraocular Pressure (IOP) assessed 2 hours after ocular instillation (at Hour 2)

Time frame: 8 Weeks

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

Percent Change from baseline to 8 weeks in Outflow Pressure Reduction Rate assessed 2 hours after ocular instillation (at Hour 2)

Time frame: 8 weeks

Data from ClinicalTrials.gov

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