search
Back to results

Safety and Efficacy Study of DuoTrav APS Versus DuoTrav

Primary Purpose

Open-angle Glaucoma, Ocular Hypertension

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
DuoTrav APS
DuoTrav
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, open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component)

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with open-angle glaucoma or ocular hypertension who would benefit from a fixed combination medication, in the opinion of the investigator and who are currently on a stable treatment of IOP-lowering medication

Exclusion Criteria:

  • VA not worse than 0.60
  • additional clinically relevant ocular or systemic conditions may be excluded

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    DuoTrav APS

    DuoTrav

    Arm Description

    DuoTrav APS QD AM

    DuoTrav QD AM

    Outcomes

    Primary Outcome Measures

    Mean Intraocular Pressure (IOP)

    Secondary Outcome Measures

    Full Information

    First Posted
    March 16, 2009
    Last Updated
    January 13, 2012
    Sponsor
    Alcon Research
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00862472
    Brief Title
    Safety and Efficacy Study of DuoTrav APS Versus DuoTrav
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2012
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Management decision not to conduct an additional efficacy study.
    Study Start Date
    March 2009 (undefined)
    Primary Completion Date
    June 2009 (Actual)
    Study Completion Date
    June 2009 (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 the study is to demonstrate that the IOP-lowering efficacy of DuoTrav APS, dosed once-daily in the morning, is non-inferior to that of DuoTrav, dosed once-daily in the morning.

    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, open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component)

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    DuoTrav APS
    Arm Type
    Experimental
    Arm Description
    DuoTrav APS QD AM
    Arm Title
    DuoTrav
    Arm Type
    Active Comparator
    Arm Description
    DuoTrav QD AM
    Intervention Type
    Drug
    Intervention Name(s)
    DuoTrav APS
    Intervention Description
    DuoTrav APS QD AM
    Intervention Type
    Drug
    Intervention Name(s)
    DuoTrav
    Intervention Description
    DuoTrav QD AM
    Primary Outcome Measure Information:
    Title
    Mean Intraocular Pressure (IOP)
    Time Frame
    3 Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with open-angle glaucoma or ocular hypertension who would benefit from a fixed combination medication, in the opinion of the investigator and who are currently on a stable treatment of IOP-lowering medication Exclusion Criteria: VA not worse than 0.60 additional clinically relevant ocular or systemic conditions may be excluded

    12. IPD Sharing Statement

    Learn more about this trial

    Safety and Efficacy Study of DuoTrav APS Versus DuoTrav

    We'll reach out to this number within 24 hrs