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

NCT00449956 | Completed Phase 3 Results

• 3 other identifiers: 0507A-149MK0507A-1492007_011
• Study Type: interventional
• Target: 474
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• 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)

  8 weeks

Secondary Outcomes (2)

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

  8 Weeks

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

  8 weeks

Study Arms (3)

1

EXPERIMENTAL

combination of dorzolamide hydrochloride and timolol maleate

Drug: dorzolamide hydrochloride (+) timolol maleate

2

ACTIVE COMPARATOR

Concomitant use of dorzolamide hydrochloride and timolol maleate

Drug: Comparator: timolol maleate; Drug: Comparator: dorzolamide hydrochloride

3

ACTIVE COMPARATOR

timolol maleate

Drug: Comparator: timolol maleate

Interventions

dorzolamide hydrochloride (+) timolol maleate DRUG

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

1

Comparator: timolol maleate DRUG

timolol maleate 0.5%, 8-week

2; 3

Comparator: dorzolamide hydrochloride DRUG

dorzolamide hydrochloride 1%, 8-week

2

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with glaucoma and ocular hypertension

You may not qualify if:

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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 21735753 RESULT

MeSH Terms

Conditions

Glaucoma

Interventions

dorzolamide-timolol combination

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2007
• First Posted: March 21, 2007
• Study Start: March 12, 2007
• Primary Completion: February 16, 2008
• Study Completion: February 16, 2008
• Last Updated: June 20, 2017
• Results First Posted: May 29, 2009

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share