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”

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

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2008

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 1: combination of dorzolamide hydrochloride and timolol maleate
• Other: 2
  • 2: concomitant use of dorzolamide hydrochloride and timolol maleate
• Active Comparator: 3
  • 3: timolol maleate

Primary Measures

• Intraocular pressure reduction
  • Time Frame: 8 Weeks
    Safety Issue?: No
• Safety profile
  • Time Frame: 8 Weeks
    Safety Issue?: Yes

Secondary Measures

• Intraocular pressure reduction rate
  • Time Frame: 8 Weeks
    Safety Issue?: No
• Outflow pressure reduction rate
  • Time Frame: 8 Weeks
    Safety Issue?: No

Inclusion Criteria:

• Patients with glaucoma and ocular hypertension

Exclusion Criteria:

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00449956

Study ID Number: 2007_011

ClinicalTrials.gov Identifier: NCT00449956

Health Authority: Japan: Pharmaceuticals and Medical Devices Agency