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

Phase 3

Completed

• Conditions: Glaucoma
• Interventions: Drug: dorzolamide hydrochloride (+) timolol maleate

• Registration Number: NCT00449956
• Lead Sponsor: Merck Sharp & Dohme LLC

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2007-03-12
• Study First Submitted: 2007-03-19
• Study First Submitted QC: 2007-03-19
• Study First Posted: 2007-03-21
• Primary Completion: 2008-02-16
• Study Completion: 2008-02-16
• Results First Submitted: 2009-01-23
• Results First Submitted QC: 2009-04-06
• Results First Posted: 2009-05-29
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-25
• Last Update Posted: 2017-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 474

Inclusion Criteria

• Patients with glaucoma and ocular hypertension

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	dorzolamide hydrochloride (+) timolol maleate	combination of dorzolamide hydrochloride and timolol maleate

Primary Outcome Measures

Name	Time	Method
Change in Intraocular Pressure (IOP) From Baseline at 8 Weeks	8 weeks	Change from baseline to 8 weeks in Intraocular Pressure (IOP) assessed 2 hours after ocular instillation (at Hour 2)

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Intraocular Pressure (IOP) at 8 Weeks	8 Weeks	Percent Change from baseline to 8 weeks in Intraocular Pressure (IOP) assessed 2 hours after ocular instillation (at Hour 2)
Percent Change From Baseline in Outflow Pressure Reduction Rate at 8 Weeks	8 weeks	Percent Change from baseline to 8 weeks in Outflow Pressure Reduction Rate assessed 2 hours after ocular instillation (at Hour 2)