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Using AGN-190584 in Subjects Utilizing Single -Use Daily, Contact Lenses

Primary Purpose

Presbyopia

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
AGN-190584
Sponsored by
Gordon Schanzlin New Vision
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia focused on measuring presbyopia

Eligibility Criteria

40 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Subjects from age 40-55 Prescription range: -4.00 - +1.00 Correctable to 20/25 or better for distance Adapted single use contact lens patients Subjects able to understand the consent agreement and willing to participate Exclusion Criteria: Non-contact lens wearer Previous use of AGN-190584 Out of age range Out of prescription range Any corneal abnormality Any eye pathology Iritis Know allergy to pilocarpine

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    single center open label, single arm study with no control and no randomization

    Arm Description

    Investigators will enroll 30 presbyopic patients between the ages of 40-55 years old who have undergone successful contact lens fitting in single-use, daily, contact lenses between the spectacle lens powers of -4.00 -to +1.00, in both eyes for best distance correction by the primary investigator

    Outcomes

    Primary Outcome Measures

    The primary endpoint will be changes from baseline in letters read at near without loss of distance acuity (defined as loss of 5 or more letters)

    Secondary Outcome Measures

    secondary endpoint will be changes in intermediate letters read from baseline

    Full Information

    First Posted
    November 14, 2022
    Last Updated
    November 21, 2022
    Sponsor
    Gordon Schanzlin New Vision
    Collaborators
    AbbVie
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05624320
    Brief Title
    Using AGN-190584 in Subjects Utilizing Single -Use Daily, Contact Lenses
    Official Title
    Improved Near Vision and Intermediate Without Loss of Binocular Distance Vision Using AGN-190584 in Subjects Utilizing Single -Use Daily, Contact Lenses for Distance Vision Correction in Both Eyes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2022 (Anticipated)
    Primary Completion Date
    May 30, 2023 (Anticipated)
    Study Completion Date
    June 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Gordon Schanzlin New Vision
    Collaborators
    AbbVie

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    AGN-190584 has gone through many clinical trials showing its safety and effectiveness in individuals from 40-55 years of age. There has been no published data on the use of this product in individuals corrected with contact lenses for distance vision. There are many other applications AGN-190584 could be used for and further studies will show the effectiveness for each.
    Detailed Description
    The study is a single center open label, single arm study with no control and no randomization. Investigators will enroll 30 presbyopic patients between the ages of 40-55 years old who have undergone successful contact lens fitting in single-use, daily, contact lenses between the spectacle lens powers of -4.00 -to +1.00, in both eyes for best distance correction by the primary investigator. Investigators will measure change in letters read at near and intermediate vision from baseline. Subjects will be required to apply AGN-190584 drops once daily OU. Subjects will be applying the drops on their own every day including the day of visits. During treatment investigators will measure changes in letters read from baseline in intermediate and near vision at the days 7, 14 and 21. These visits will be conducted between 2 and 4 hours after instillation of AGN-190584, with 3 hours being the target time.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Presbyopia
    Keywords
    presbyopia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    single center open label, single arm study with no control and no randomization
    Arm Type
    Experimental
    Arm Description
    Investigators will enroll 30 presbyopic patients between the ages of 40-55 years old who have undergone successful contact lens fitting in single-use, daily, contact lenses between the spectacle lens powers of -4.00 -to +1.00, in both eyes for best distance correction by the primary investigator
    Intervention Type
    Drug
    Intervention Name(s)
    AGN-190584
    Intervention Description
    miotic for treatment of presbyopia
    Primary Outcome Measure Information:
    Title
    The primary endpoint will be changes from baseline in letters read at near without loss of distance acuity (defined as loss of 5 or more letters)
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    secondary endpoint will be changes in intermediate letters read from baseline
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Subjects from age 40-55 Prescription range: -4.00 - +1.00 Correctable to 20/25 or better for distance Adapted single use contact lens patients Subjects able to understand the consent agreement and willing to participate Exclusion Criteria: Non-contact lens wearer Previous use of AGN-190584 Out of age range Out of prescription range Any corneal abnormality Any eye pathology Iritis Know allergy to pilocarpine
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    David I Geffen, OD
    Phone
    18584559950
    Email
    dgeffen@gwsvision.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Garret Pennel, OD
    Phone
    (858) 455-6800
    Email
    gpennel@gwsvision.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Using AGN-190584 in Subjects Utilizing Single -Use Daily, Contact Lenses

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