COSOPT (Timolol/Dorzolamide Combination) Normal Tension Glaucoma Study (MK0507A-161)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00832377
First received: January 29, 2009
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

A study to evaluate the effect of the 12-week treatment with timolol/dorzolamide combination eyedrops (COSOPT) on decrease in intraocular pressure (IOP) at 2 hours after the study drug administration


Condition Intervention Phase
Glaucoma
Drug: timolol/dorzolamide combination
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Open-label, Single-arm Study to Evaluate Efficacy and Safety of Combination Therapy of Timolol and Dorzolamide (COSOPT) as Initial Treatment for Patients With Normal Tension Glaucoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Mean Change in the Peak Intraocular Pressure (IOP) Measured Two Hours After Study Drug Administration at Week 12 Compared to Baseline IOP. [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

    The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement.

    IOP was measured in both eyes and the eye with the higher IOP was used for the participant.



Secondary Outcome Measures:
  • Mean Change in Trough IOP Measured Right Before Study Drug Administration at Week 12 Compared to Baseline IOP. [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

    The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement.

    IOP was measured in both eyes and the eye with the higher IOP was used for the participant.


  • Mean Change in IOP 8 Hours After the Study Drug Administration at Week 12 Compared to Baseline IOP [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

    The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement.

    IOP was measured in both eyes and the eye with the higher IOP was used for the participant.



Other Outcome Measures:
  • Baseline IOP [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    Baseline IOP was measured at ~9 AM of first day of treatment period.

    IOP was measured in both eyes and the eye with the higher IOP was used for the participant.



Enrollment: 37
Study Start Date: April 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Timolol/Dorzolamide
Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
Drug: timolol/dorzolamide combination
Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
Other Name: Cosopt

  Eligibility

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

Inclusion Criteria:

  • Patients who have not been treated with a glaucoma medication within 6 weeks prior to study participation after diagnosis with primary open-angle glaucoma
  • Patients with primary open-angle glaucoma based on gonioscopy
  • Patients with normal tension glaucoma diagnosed based on accompanying optic disc cupping and reappearance of visual field defect corresponding to retinal nerve fiber layer defect.
  • Subjects with < 22 mm Hg of diurnal IOP measured using Goldmann applanation tonometer (every two hours between 9 a.m. and 5 p.m.)

Exclusion Criteria:

  • Patients with another type of glaucoma but primary open-angle glaucoma
  • Patients treated with other glaucoma medications within 6 weeks prior to study participation
  • Patients with a history of chronic ocular inflammation or recurrent ocular inflammation
  • Patients using contact lenses
  • Patients who are allergic to timolol or dorzolamide
  • Patients with a history of any of the following COSOPT (timolol/dorzolamide combination) contraindications:

    • Reactive airway diseases
    • Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock
    • Severe renal impairment
  • Patients with a history of significant ocular trauma or intraocular surgery within 6 months before participating the study, or intraocular laser surgery within 3 months before the participating the study
  • Patients with a history of a corneal disease
  • Patients who are using steroid or used the drug for more than 2 weeks within 12 months before participating the study
  • Pregnant women
  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: NCT00832377

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: NCT00832377     History of Changes
Other Study ID Numbers: 0507A-161, 2009_524
Study First Received: January 29, 2009
Results First Received: February 25, 2011
Last Updated: February 12, 2014
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014