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A Multi-Dose Study With a Treatment for Open-Angle Glaucoma

Primary Purpose

Open-Angle Glaucoma

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Anecortave Acetate
Anecortave Acetate
Anecortave Acetate
Placebo
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, Intraocular Pressure, Anecortave Acetate

Eligibility Criteria

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

Inclusion Criteria:

  • Patients at least 18 years old with a clinical diagnosis of Open-Angle Glaucoma for at least 6 months and currently treated with a monotherapy hypotensive medication

Exclusion Criteria:

  • Prior angle surgery in the study eye, severe visual field loss in either eye, and any other form of glaucoma besides open-angle glaucoma

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Experimental

    Arm Label

    1

    2

    3

    4

    Arm Description

    Placebo treatment with vehicle

    Low dose of study medication

    Middle dose of study medication

    High dose of study medication

    Outcomes

    Primary Outcome Measures

    Mean Intraocular Pressure

    Secondary Outcome Measures

    Percent of patients with therapeutic benefit, number and percent of treatment failure and time to treatment failure

    Full Information

    First Posted
    June 24, 2008
    Last Updated
    May 29, 2012
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00705770
    Brief Title
    A Multi-Dose Study With a Treatment for Open-Angle Glaucoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2008
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Change in study design
    Study Start Date
    May 2008 (undefined)
    Primary Completion Date
    July 2008 (Actual)
    Study Completion Date
    July 2008 (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 determine whether Anecortave Acetate is effective for lowering intraocular pressure caused by open-angle glaucoma.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Open-Angle Glaucoma
    Keywords
    Open-Angle Glaucoma, Intraocular Pressure, Anecortave Acetate

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo treatment with vehicle
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Low dose of study medication
    Arm Title
    3
    Arm Type
    Experimental
    Arm Description
    Middle dose of study medication
    Arm Title
    4
    Arm Type
    Experimental
    Arm Description
    High dose of study medication
    Intervention Type
    Drug
    Intervention Name(s)
    Anecortave Acetate
    Intervention Description
    Low dose Sustained release depot suspension
    Intervention Type
    Drug
    Intervention Name(s)
    Anecortave Acetate
    Intervention Description
    Middle dose Sustained release depot suspension
    Intervention Type
    Drug
    Intervention Name(s)
    Anecortave Acetate
    Intervention Description
    High dose Sustained release depot suspension
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo treatment with vehicle
    Primary Outcome Measure Information:
    Title
    Mean Intraocular Pressure
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Percent of patients with therapeutic benefit, number and percent of treatment failure and time to treatment failure
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients at least 18 years old with a clinical diagnosis of Open-Angle Glaucoma for at least 6 months and currently treated with a monotherapy hypotensive medication Exclusion Criteria: Prior angle surgery in the study eye, severe visual field loss in either eye, and any other form of glaucoma besides open-angle glaucoma

    12. IPD Sharing Statement

    Learn more about this trial

    A Multi-Dose Study With a Treatment for Open-Angle Glaucoma

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