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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00449956
First received: March 19, 2007
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Glaucoma
Drug: dorzolamide hydrochloride (+) timolol maleate
Drug: Comparator: timolol maleate
Drug: Comparator: dorzolamide hydrochloride
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change in Intraocular Pressure (IOP) From Baseline at 8 Weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Percent Change from baseline to 8 weeks in Outflow Pressure Reduction Rate assessed 2 hours after ocular instillation (at Hour 2)


Enrollment: 474
Study Start Date: March 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
combination of dorzolamide hydrochloride and timolol maleate
Drug: dorzolamide hydrochloride (+) timolol maleate
Dorzolamide hydrochloride 1% + timolol 0.5%, 8-week
Active Comparator: 2
Concomitant use of dorzolamide hydrochloride and timolol maleate
Drug: Comparator: timolol maleate
timolol maleate 0.5%, 8-week
Drug: Comparator: dorzolamide hydrochloride
dorzolamide hydrochloride 1%, 8-week
Active Comparator: 3
timolol maleate
Drug: Comparator: timolol maleate
timolol maleate 0.5%, 8-week

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with glaucoma and ocular hypertension

Exclusion Criteria:

  • History of ocular surgery within 3 months
  • Administration contradiction to timolol and dorzolamide
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00449956

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00449956     History of Changes
Other Study ID Numbers: 0507A-149, MK0507A-149, 2007_011
Study First Received: March 19, 2007
Results First Received: January 23, 2009
Last Updated: April 25, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Hypertension
Glaucoma
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Timolol
Dorzolamide
Maleic acid
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Enzyme Inhibitors
Carbonic Anhydrase Inhibitors

ClinicalTrials.gov processed this record on October 02, 2014