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

Primary Purpose

Glaucoma

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

dorzolamide hydrochloride (+) timolol maleate

Comparator: timolol maleate

Comparator: dorzolamide hydrochloride

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

combination of dorzolamide hydrochloride and timolol maleate

Concomitant use of dorzolamide hydrochloride and timolol maleate

timolol maleate

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

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)

Full Information

NCT ID

NCT00449956

First Posted

March 19, 2007

Last Updated

May 25, 2017

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00449956

Brief Title

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

Official Title

Multicenter, Double-Blind, Active Comparator-controlled Study to Evaluate the Safety and Efficacy of MK0507A in Patients With Glaucoma and Ocular Hypertension Who Are Inadequately Controlled on Beta-Blockers

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

March 12, 2007 (Actual)

Primary Completion Date

February 16, 2008 (Actual)

Study Completion Date

February 16, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

474 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

combination of dorzolamide hydrochloride and timolol maleate

Arm Title

Arm Type

Active Comparator

Arm Description

Concomitant use of dorzolamide hydrochloride and timolol maleate

Arm Title

Arm Type

Active Comparator

Arm Description

timolol maleate

Intervention Type

Drug

Intervention Name(s)

dorzolamide hydrochloride (+) timolol maleate

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Comparator: timolol maleate

Intervention Description

timolol maleate 0.5%, 8-week

Intervention Type

Drug

Intervention Name(s)

Comparator: dorzolamide hydrochloride

Intervention Description

dorzolamide hydrochloride 1%, 8-week

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

8 Weeks

Title

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

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

Citations:

PubMed Identifier

21735753

Citation

Kitazawa Y, Araie M; Research Group on MK-0507A. [Double-masked, phase III comparative study of the combination ophthalmic solution of the 1% dorzolamide hydrochloride/0.5% timolol maleate (MK-0507A) in patients with glaucoma and ocular hypertension]. Nippon Ganka Gakkai Zasshi. 2011 Jun;115(6):495-507. Japanese.

Results Reference

result

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

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