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

Primary Purpose

Glaucoma

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
timolol/dorzolamide combination
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Timolol/Dorzolamide

    Arm Description

    Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks

    Outcomes

    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.
    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.
    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
    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.

    Full Information

    First Posted
    January 29, 2009
    Last Updated
    August 31, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00832377
    Brief Title
    COSOPT (Timolol/Dorzolamide Combination) Normal Tension Glaucoma Study (MK0507A-161)(COMPLETED)
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 24, 2009 (Actual)
    Primary Completion Date
    March 12, 2010 (Actual)
    Study Completion Date
    March 26, 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glaucoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    37 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Timolol/Dorzolamide
    Arm Type
    Experimental
    Arm Description
    Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    timolol/dorzolamide combination
    Other Intervention Name(s)
    Cosopt
    Intervention Description
    Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
    Primary Outcome Measure Information:
    Title
    Mean Change in the Peak Intraocular Pressure (IOP) Measured Two Hours After Study Drug Administration at Week 12 Compared to Baseline IOP.
    Description
    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.
    Time Frame
    Baseline and 12 weeks
    Secondary Outcome Measure Information:
    Title
    Mean Change in Trough IOP Measured Right Before Study Drug Administration at Week 12 Compared to Baseline IOP.
    Description
    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.
    Time Frame
    Baseline and 12 weeks
    Title
    Mean Change in IOP 8 Hours After the Study Drug Administration at Week 12 Compared to Baseline IOP
    Description
    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.
    Time Frame
    Baseline and 12 weeks
    Other Pre-specified Outcome Measures:
    Title
    Baseline IOP
    Description
    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.
    Time Frame
    Baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    23377586
    Citation
    Kim TW, Kim M, Lee EJ, Jeoung JW, Park KH. Intraocular pressure-lowering efficacy of dorzolamide/timolol fixed combination in normal-tension glaucoma. J Glaucoma. 2014 Jun-Jul;23(5):329-32. doi: 10.1097/IJG.0b013e3182741f4d.
    Results Reference
    result

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

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