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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00108017
Recruitment Status : Completed
First Posted : April 13, 2005
Last Update Posted : May 13, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

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

Condition or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : April 2005
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 24 hour diurnal IOP reduction after 8 weeks of treatment [ Time Frame: After 8 weeks of treatment ]

Secondary Outcome Measures :
  1. IOP reduction a) from baseline at 6 weeks; b) comparison with timolol; c) comparison day versus night [ Time Frame: At 6 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00108017


Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme LLC
More Information
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Publications:

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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT00108017    
Other Study ID Numbers: 0507A-137
2005_021
First Posted: April 13, 2005    Key Record Dates
Last Update Posted: May 13, 2015
Last Verified: May 2015
Keywords provided by Merck Sharp & Dohme LLC:
Ocular hypertension (excessive pressure in the eye)
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
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
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Enzyme Inhibitors
Carbonic Anhydrase Inhibitors