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

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00449956
• Other study ID #: 0507A-149
• Secondary ID: MK0507A-1492007_
• Status: Completed
• Phase: Phase 3
• First received: March 19, 2007
• Last updated: April 7, 2015
• Start date: March 2007
• Est. completion date: February 2008

Study information

• Verified date: April 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 474
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients with glaucoma and ocular hypertension

Exclusion Criteria:

• History of ocular surgery within 3 months

• Administration contradiction to timolol and dorzolamide

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Ocular Hypertension

Intervention

Drug:
• dorzolamide hydrochloride (+) timolol maleate
Dorzolamide hydrochloride 1% + timolol 0.5%, 8-week
• Comparator: timolol maleate
timolol maleate 0.5%, 8-week
• Comparator: dorzolamide hydrochloride
dorzolamide hydrochloride 1%, 8-week

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & 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]. Nip — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	8 Weeks	No
Secondary	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)	8 weeks	No

External Links

•   MedWatch - FDA maintained medical product safety Information
•   Merck: Patient & Caregiver U.S. Product Web Site