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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

March 19, 2007
April 20, 2010
April 2007
February 2008   (final data collection date for primary outcome measure)
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)
  • Intraocular pressure reduction
  • Safety profile
Complete list of historical versions of study NCT00449956 on ClinicalTrials.gov Archive Site
  • 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)
  • Intraocular pressure reduction rate
  • Outflow pressure reduction rate
Not Provided
Not Provided
 
MK0507A Clinical Study in Patients With Glaucoma and Ocular Hypertension
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Glaucoma
  • Drug: dorzolamide hydrochloride (+) timolol maleate
    Dorzolamide hydrochloride 1% + timolol 0.5%, 8-week
  • Drug: Comparator: timolol maleate
    timolol maleate 0.5%, 8-week
  • Drug: Comparator: dorzolamide hydrochloride
    dorzolamide hydrochloride 1%, 8-week
  • Experimental: 1
    combination of dorzolamide hydrochloride and timolol maleate
    Intervention: Drug: dorzolamide hydrochloride (+) timolol maleate
  • Active Comparator: 2
    Concomitant use of dorzolamide hydrochloride and timolol maleate
    Interventions:
    • Drug: Comparator: timolol maleate
    • Drug: Comparator: dorzolamide hydrochloride
  • Active Comparator: 3
    timolol maleate
    Intervention: Drug: Comparator: timolol maleate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
474
May 2008
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with glaucoma and ocular hypertension

Exclusion Criteria:

  • History of ocular surgery within 3 months
  • Administration contradiction to timolol and dorzolamide
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00449956
2007_011, MK0507A-149
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
Merck
Not Provided
Study Director: Medical Monitor Merck
Merck
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP