Comparison of the Effects of Two Glaucoma Drugs Over 24 Hours (0507A-137)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00108017
First received: April 12, 2005
Last updated: May 20, 2013
Last verified: May 2013
  Purpose

This study is comparing 2 medications for glaucoma and how effective they are at controlling glaucoma over the course of an entire day.


Condition Intervention Phase
Glaucoma
Ocular Hypertension
Drug: MK0507A, dorzolamide hydrochloride (+) timolol maleate
Drug: Comparator: timolol maleate
Drug: Duration of Treatment: Part 1) 6 wk timolol maleate run in
Drug: Part 2) 6 wk washout pd Part 3) two 8 wk active tx pds
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Multicenter, Dbl-Masked, Parallel Study Evaluating the 24 Hr. Diurnal Ocular Hypotensive Effect of 2% Dorzolamide Hydrochloride/0.5% Timolol Maleate Combo. Ophthalmic Sol. in Patients w/ Open Angle Glaucoma or Ocular Hypertension

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 24 hour diurnal IOP reduction after 8 weeks of treatment [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • IOP reduction a) from baseline at 6 weeks; b) comparison with timolol; c) comparison day versus night [ Time Frame: At 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 330
Study Start Date: July 2005
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with glaucoma or ocular hypertension

Exclusion Criteria:

  • Other eye conditions
  • Poor vision
  • Recent eye surgery
  • Use of contact lenses
  • Nursing or pregnant women
  • Use of some other selected medications
  • Drug or alcohol abuse
  • Asthma
  • Slow heart beat
  • Allergy or previous reaction to study drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00108017

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

Publications:
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00108017     History of Changes
Other Study ID Numbers: 2005_021, MK0507A-137
Study First Received: April 12, 2005
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Ocular hypertension (excessive pressure in the eye)

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 April 16, 2014