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MK0507A Clinical Study in Patients With Glaucoma and Ocular Hypertension

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00449956
First received: March 19, 2007
Last updated: April 20, 2010
Last verified: April 2010
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Merck:

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: April 2007
Study Completion Date: May 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00449956

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Additional Information:
MedWatch - FDA maintained medical product safety Information  This link exits the ClinicalTrials.gov site
Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00449956     History of Changes
Other Study ID Numbers: 2007_011, MK0507A-149
Study First Received: March 19, 2007
Results First Received: January 23, 2009
Last Updated: April 20, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular 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 May 16, 2013