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Safety And Efficacy Of Xalatan Delivered Using Either A Conventional Dropper Bottle or A Delivery Device

Primary Purpose

Glaucoma, Open-Angle, Ocular Hypertension

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Xalatan
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle

Eligibility Criteria

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

Inclusion Criteria: Diagnosis of primary open angle glaucoma or ocular hypertension in 1 or both eyes Exclusion Criteria: History of closed/barely open anterior chamber angle or a history of angle closure

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Intra-ocular pressure (IOP) level in the study eye.

    Secondary Outcome Measures

    Successful eyedrop self-deliveries
    Ease of eyedrop administration
    Change in safety assessments throughout the study period
    Subject preference for the method of drop delivery

    Full Information

    First Posted
    January 26, 2006
    Last Updated
    February 1, 2021
    Sponsor
    Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00283764
    Brief Title
    Safety And Efficacy Of Xalatan Delivered Using Either A Conventional Dropper Bottle or A Delivery Device
    Official Title
    A Phase 3, 12-Week, Parallel-Design Study Comparing The Safety, Efficacy, and Ease Of Use Of Xalatan When Self-Administered By Subjects With Open-Angle Glaucoma Or Ocular Hypertension Using Either A Conventional Dropper Bottle Or A Forced-Flow Delivery Device
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    Compare the antihypertensive efficacy of two methods for instilling Xalatan eyedrops

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glaucoma, Open-Angle, Ocular Hypertension

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Xalatan
    Primary Outcome Measure Information:
    Title
    Intra-ocular pressure (IOP) level in the study eye.
    Secondary Outcome Measure Information:
    Title
    Successful eyedrop self-deliveries
    Title
    Ease of eyedrop administration
    Title
    Change in safety assessments throughout the study period
    Title
    Subject preference for the method of drop delivery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of primary open angle glaucoma or ocular hypertension in 1 or both eyes Exclusion Criteria: History of closed/barely open anterior chamber angle or a history of angle closure
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pfizer CT.gov Call Center
    Organizational Affiliation
    Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Safety And Efficacy Of Xalatan Delivered Using Either A Conventional Dropper Bottle or A Delivery Device

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