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12-Month Stability of Diurnal IOP Control on Cosopt

Primary Purpose

Glaucoma

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Cosopt
Sponsored by
West Virginia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring glaucoma, diurnal, intraocular pressure

Eligibility Criteria

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

Inclusion Criteria:

  • bilateral open-angle glaucoma

Exclusion Criteria:

  • contraindications to Cosopt
  • pathology affecting tonometry

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Active Comparator

    Arm Label

    Cosopt

    Arm Description

    Cosopt twice daily in both eyes

    Outcomes

    Primary Outcome Measures

    Diurnal Intraocular Pressure Control
    Change from baseline in mean diurnal IOP (measured every two hours from 8AM to 8PM) averaged across on-treatment study visits (week 1, months 1, 6, 12)

    Secondary Outcome Measures

    Full Information

    First Posted
    September 21, 2006
    Last Updated
    January 26, 2015
    Sponsor
    West Virginia University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00379834
    Brief Title
    12-Month Stability of Diurnal IOP Control on Cosopt
    Official Title
    12-Month Stability of Diurnal IOP Control on Cosopt
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2006 (undefined)
    Primary Completion Date
    April 2008 (Actual)
    Study Completion Date
    April 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    West Virginia University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To determine the stability of diurnal intraocular pressure in eyes with glaucoma treated with Cosopt
    Detailed Description
    Glaucoma is a potentially-blinding but treatable eye disease. A major risk factor for glaucoma is elevated intraocular pressure (IOP). IOP is a dynamic variable (like blood pressure)-it changes over time. The more it changes, the more likely patients are to get worse. Glaucoma is treated by lowering IOP. Cosopt is a medication that lowers IOP. Little is known about how well Cosopt reduces IOP fluctuations. In this study, we plan to measure the IOP in both eyes of 10 glaucoma patients treated with Cosopt, every 2 hours from 8am to 8pm, on five separate days over a one-year period. Untreated baseline IOP will be measured on a similar long day before beginning treatment with Cosopt. This methodology will allow us to compare IOP fluctuations with and without Cosopt, and also to learn about long-term control of IOP fluctuations in eyes treated with Cosopt.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glaucoma
    Keywords
    glaucoma, diurnal, intraocular pressure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cosopt
    Arm Type
    Active Comparator
    Arm Description
    Cosopt twice daily in both eyes
    Intervention Type
    Drug
    Intervention Name(s)
    Cosopt
    Other Intervention Name(s)
    Dorzolamide/timolol fixed combination
    Intervention Description
    Cosopt twice daily in both eyes
    Primary Outcome Measure Information:
    Title
    Diurnal Intraocular Pressure Control
    Description
    Change from baseline in mean diurnal IOP (measured every two hours from 8AM to 8PM) averaged across on-treatment study visits (week 1, months 1, 6, 12)
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: bilateral open-angle glaucoma Exclusion Criteria: contraindications to Cosopt pathology affecting tonometry
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anthony D Realini, MD
    Organizational Affiliation
    West Virginia University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    12-Month Stability of Diurnal IOP Control on Cosopt

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