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Three Month Safety and Efficacy Study of TRAVATAN® Versus Travoprost Ophthalmic Solution, 0.004%

Primary Purpose

Open Angle Glaucoma, Ocular Hypertension

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Travoprost Ophthalmic Solution, 0.004% (New Formulation)
TRAVATAN®
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

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients 18 years of age or older
  2. Either gender
  3. Any race/ethnicity
  4. Diagnosed with open-angle glaucoma (including patients with pseudoexfoliation and pigment dispersion) or ocular hypertension

Exclusion Criteria:

  1. Patients with any form of glaucoma other than open-angle glaucoma.
  2. Patients with a central cornea thickness greater than 620 μm
  3. Patients with Shaffer angle Grade < 2
  4. Patients with a cup/disc ratio greater than 0.80
  5. Patients with severe central visual field loss
  6. Best-Corrected Visual Acuity score worse than 55 ETDRS letters (20/80 Snellen equivalent)
  7. Chronic, recurrent or severe inflammatory eye disease
  8. Clinically significant or progressive retinal disease
  9. Other ocular pathology

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Travoprost Ophthalmic Solution, 0.004% (New Formulation)

    TRAVATAN®

    Arm Description

    TRAVATAN® administered one drop once daily

    Outcomes

    Primary Outcome Measures

    Efficacy: mean IOP Efficacy as measured by mean IOP

    Secondary Outcome Measures

    Full Information

    First Posted
    October 12, 2011
    Last Updated
    February 9, 2012
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01452009
    Brief Title
    Three Month Safety and Efficacy Study of TRAVATAN® Versus Travoprost Ophthalmic Solution, 0.004%
    Official Title
    Three Month Safety and Efficacy Study of TRAVATAN® vs Travoprost Ophthalmic Solution, 0.004%
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2012
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Management Decision
    Study Start Date
    November 2011 (undefined)
    Primary Completion Date
    December 2011 (Actual)
    Study Completion Date
    December 2011 (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
    A multi-center, observer-masked, randomized, parallel group efficacy and safety study of TRAVATAN® versus a new formulation of Travoprost Ophthalmic Solution, 0.004%

    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

    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
    Travoprost Ophthalmic Solution, 0.004% (New Formulation)
    Arm Type
    Experimental
    Arm Title
    TRAVATAN®
    Arm Type
    Active Comparator
    Arm Description
    TRAVATAN® administered one drop once daily
    Intervention Type
    Drug
    Intervention Name(s)
    Travoprost Ophthalmic Solution, 0.004% (New Formulation)
    Intervention Description
    Travoprost Ophthalmic Solution, 0.004% given one drop once daily
    Intervention Type
    Drug
    Intervention Name(s)
    TRAVATAN®
    Intervention Description
    TRAVATAN® administered one drop once daily
    Primary Outcome Measure Information:
    Title
    Efficacy: mean IOP Efficacy as measured by mean 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 18 years of age or older Either gender Any race/ethnicity Diagnosed with open-angle glaucoma (including patients with pseudoexfoliation and pigment dispersion) or ocular hypertension Exclusion Criteria: Patients with any form of glaucoma other than open-angle glaucoma. Patients with a central cornea thickness greater than 620 μm Patients with Shaffer angle Grade < 2 Patients with a cup/disc ratio greater than 0.80 Patients with severe central visual field loss Best-Corrected Visual Acuity score worse than 55 ETDRS letters (20/80 Snellen equivalent) Chronic, recurrent or severe inflammatory eye disease Clinically significant or progressive retinal disease Other ocular pathology

    12. IPD Sharing Statement

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