search
Back to results

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

Primary Purpose

Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0507A, dorzolamide hydrochloride (+) timolol maleate
Comparator: timolol maleate
Duration of Treatment: Part 1) 6 wk timolol maleate run in
Part 2) 6 wk washout pd Part 3) two 8 wk active tx pds
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Ocular hypertension (excessive pressure in the eye)

Eligibility Criteria

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

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    24 hour diurnal IOP reduction after 8 weeks of treatment

    Secondary Outcome Measures

    IOP reduction a) from baseline at 6 weeks; b) comparison with timolol; c) comparison day versus night

    Full Information

    First Posted
    April 12, 2005
    Last Updated
    May 12, 2015
    Sponsor
    Merck Sharp & Dohme LLC
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00108017
    Brief Title
    Comparison of the Effects of Two Glaucoma Drugs Over 24 Hours (0507A-137)(COMPLETED)
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2005 (undefined)
    Primary Completion Date
    July 2006 (Actual)
    Study Completion Date
    July 2006 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glaucoma, Ocular Hypertension
    Keywords
    Ocular hypertension (excessive pressure in the eye)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    330 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0507A, dorzolamide hydrochloride (+) timolol maleate
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: timolol maleate
    Intervention Type
    Drug
    Intervention Name(s)
    Duration of Treatment: Part 1) 6 wk timolol maleate run in
    Intervention Type
    Drug
    Intervention Name(s)
    Part 2) 6 wk washout pd Part 3) two 8 wk active tx pds
    Primary Outcome Measure Information:
    Title
    24 hour diurnal IOP reduction after 8 weeks of treatment
    Time Frame
    After 8 weeks of treatment
    Secondary Outcome Measure Information:
    Title
    IOP reduction a) from baseline at 6 weeks; b) comparison with timolol; c) comparison day versus night
    Time Frame
    At 6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    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

    Citations:
    PubMed Identifier
    18627642
    Citation
    Feldman RM, Stewart RH, Stewart WC, Jia G, Smugar SS, Galet VA. 24-hour control of intraocular pressure with 2% dorzolamide/0.5% timolol fixed-combination ophthalmic solution in open-angle glaucoma. Curr Med Res Opin. 2008 Aug;24(8):2403-12. doi: 10.1185/03007990802243366. Epub 2008 Jul 14.
    Results Reference
    background
    PubMed Identifier
    19441888
    Citation
    Olander KW, Galet VA, Jia G, Smugar SS, Stewart WC. Relationship between visual field severity and response to fixed combination dorzolamide/timolol or timolol alone. J Ocul Pharmacol Ther. 2009 Aug;25(4):357-64. doi: 10.1089/jop.2008.0104.
    Results Reference
    background

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs