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Corneal Versus Conjunctival Delivery Using a Delivery Device

Primary Purpose

Glaucoma, Open-Angle, Ocular Hypertension

Status
Withdrawn
Phase
Phase 2
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 focused on measuring Primary Open Angle Glaucoma

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

    IOP level in the study eye

    Secondary Outcome Measures

    Change in ocular safety assessments. Ocular and systemic adverse events throughout the study period

    Full Information

    First Posted
    September 1, 2005
    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
    NCT00143429
    Brief Title
    Corneal Versus Conjunctival Delivery Using a Delivery Device
    Official Title
    Effect Of Corneal Versus Conjunctival Delivery On The Corneal Safety, Tolerability, and Antihypertensive Efficacy Of The Xalatan Ophthalmic 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    Withdrawn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 three methods for installing Xalatan

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover 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
    IOP level in the study eye
    Secondary Outcome Measure Information:
    Title
    Change in ocular safety assessments. Ocular and systemic adverse events throughout the study period

    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

    Corneal Versus Conjunctival Delivery Using a Delivery Device

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