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Phase III Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-Angle Glaucoma or Ocular Hypertension Patients

Primary Purpose

Open-angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Travoprost 0.004% with and without BAK
Sponsored by
Alcon Research
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open-angle Glaucoma

Eligibility Criteria

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

Inclusion Criteria: Adult subjects of either sex and any race 18 years or older with open-angle glaucoma or ocular hypertension. Patients with logMAR visual acuity not worse than 0.6 in either eye or any clinically relevant ophthalmic/systemic condition will be excluded. Exclusion Criteria: See Inclusion Criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 7, 2006
    Last Updated
    August 16, 2012
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00288951
    Brief Title
    Phase III Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-Angle Glaucoma or Ocular Hypertension Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2004 (undefined)
    Primary Completion Date
    June 2005 (Actual)
    Study Completion Date
    June 2005 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to determine the safety and IOP-lowering ability of a glaucoma therapy 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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Travoprost 0.004% with and without BAK

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult subjects of either sex and any race 18 years or older with open-angle glaucoma or ocular hypertension. Patients with logMAR visual acuity not worse than 0.6 in either eye or any clinically relevant ophthalmic/systemic condition will be excluded. Exclusion Criteria: See Inclusion Criteria

    12. IPD Sharing Statement

    Learn more about this trial

    Phase III Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-Angle Glaucoma or Ocular Hypertension Patients

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