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Safety Study of DuoTrav APS in Patients With Open-Angle Glaucoma or Ocular Hypertension

Primary Purpose

Open-angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Travoprost/Timolol Maleate Fixed Combination solution
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open-angle Glaucoma focused on measuring open-angle glaucoma, ocular hypertension, pseudoexfoliation, pigment dispersion

Eligibility Criteria

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

Inclusion Criteria:

  • Willing and able to sign an informed consent document.
  • Open-angle glaucoma or ocular hypertension who would benefit from a fixed combination medication, in the opinion of the investigator.
  • Stable treatment of an IOP-lowering medication.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Pregnant, breastfeeding, or not using adequate birth control.
  • Best-corrected visual acuity (BCVA) worse than 55 ETDRS letters.
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    DuoTrav APS

    Arm Description

    Travoprost/Timolol Maleate Fixed Combination solution, 1 drop in the study eye(s) once daily, at 9 AM, for 12 months

    Outcomes

    Primary Outcome Measures

    Adverse Events (AEs)

    Secondary Outcome Measures

    Full Information

    First Posted
    June 24, 2009
    Last Updated
    July 16, 2014
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00928590
    Brief Title
    Safety Study of DuoTrav APS in Patients With Open-Angle Glaucoma or Ocular Hypertension
    Official Title
    A Twelve-Month Open-Label Safety Study of Polyquaternium-Preserved DuoTrav APS Dosed Once Daily in Patients With Open-Angle Glaucoma or Ocular Hypertension
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2009 (undefined)
    Primary Completion Date
    November 2010 (Actual)
    Study Completion Date
    November 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alcon Research

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to describe the long-term safety of a fixed combination product containing an alternative preservative, dosed once daily for 12 months, in patients with open-angle glaucoma or ocular hypertension.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Open-angle Glaucoma, Ocular Hypertension
    Keywords
    open-angle glaucoma, ocular hypertension, pseudoexfoliation, pigment dispersion

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    155 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    DuoTrav APS
    Arm Type
    Experimental
    Arm Description
    Travoprost/Timolol Maleate Fixed Combination solution, 1 drop in the study eye(s) once daily, at 9 AM, for 12 months
    Intervention Type
    Drug
    Intervention Name(s)
    Travoprost/Timolol Maleate Fixed Combination solution
    Other Intervention Name(s)
    DuoTrav APS, DuoTrav (POLYQUAD-preserved)
    Primary Outcome Measure Information:
    Title
    Adverse Events (AEs)
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Willing and able to sign an informed consent document. Open-angle glaucoma or ocular hypertension who would benefit from a fixed combination medication, in the opinion of the investigator. Stable treatment of an IOP-lowering medication. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Pregnant, breastfeeding, or not using adequate birth control. Best-corrected visual acuity (BCVA) worse than 55 ETDRS letters. Other protocol-defined exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Theresa Landry, Ph.D
    Organizational Affiliation
    Alcon Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Safety Study of DuoTrav APS in Patients With Open-Angle Glaucoma or Ocular Hypertension

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