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Delaying the Onset of Nearsightedness Until Treatment Study (DONUT)

Primary Purpose

Myopia

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Atropine Ophthalmic
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Myopia

Eligibility Criteria

6 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age: 6-11 years Refractive error measured in spherical equivalent, one eye meets criterion 6 years old: 0.50 to +0.38 7 years old: 0.50 to +0.25 8-11 years old: 0.50 to plano Anisometropia: spherical equivalent <1.50 D Astigmatism: <1.50 in both eyes Myopia: Less myopic than -0.74 D, both eyes Exclusion Criteria: ● Myopic

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    0.01% Atropine

    0.03% Atropine

    0.05% atropine

    Arm Description

    0.01% atropine eye drops

    0.03% atropine eye drops

    0.05% atropine eye drops

    Outcomes

    Primary Outcome Measures

    Compliance percentage
    A comparison of the compliance percentage with eye drop administration

    Secondary Outcome Measures

    Full Information

    First Posted
    August 24, 2023
    Last Updated
    August 31, 2023
    Sponsor
    Ohio State University
    Collaborators
    University of Houston, State University of New York, Pennsylvania College of Optometry, Southern California College of Optometry at Marshall B. Ketchum University, University of California, Berkeley, Stanford University, Case Western Reserve University, Illinois College of Optometry, Indiana University, New England College of Optometry, University of the Incarnate Word, Southern College of Optometry, University of Missouri, St. Louis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06029530
    Brief Title
    Delaying the Onset of Nearsightedness Until Treatment Study
    Acronym
    DONUT
    Official Title
    Delaying the Onset of Nearsightedness Until Treatment Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    August 31, 2024 (Anticipated)
    Study Completion Date
    August 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ohio State University
    Collaborators
    University of Houston, State University of New York, Pennsylvania College of Optometry, Southern California College of Optometry at Marshall B. Ketchum University, University of California, Berkeley, Stanford University, Case Western Reserve University, Illinois College of Optometry, Indiana University, New England College of Optometry, University of the Incarnate Word, Southern College of Optometry, University of Missouri, St. Louis

    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.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Participants eligible for the study will be randomized to one of three concentrations of atropine and followed for a month.
    Detailed Description
    Participants will be identified through screening that fit the criteria of a pre-myopic child, which will depend on age and the amount of refractive error at that time. These children will be randomized for a pilot study measuring compliance in nightly eye drop administration. The outcome will be thirty days after randomization, and will assess whether or not there is a difference in compliance between one of three dosages of atropine (0.01%, 0.03%, and 0.05%).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants will receive one of three concentrations of atropine (0.01%, 0.03%, or 0.05%)
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    De-identified bottles will be sent to the sites with randomization codes. The key will be kept at the data coordinating center.
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    0.01% Atropine
    Arm Type
    Active Comparator
    Arm Description
    0.01% atropine eye drops
    Arm Title
    0.03% Atropine
    Arm Type
    Active Comparator
    Arm Description
    0.03% atropine eye drops
    Arm Title
    0.05% atropine
    Arm Type
    Active Comparator
    Arm Description
    0.05% atropine eye drops
    Intervention Type
    Drug
    Intervention Name(s)
    Atropine Ophthalmic
    Intervention Description
    eye drops to be administered once daily
    Primary Outcome Measure Information:
    Title
    Compliance percentage
    Description
    A comparison of the compliance percentage with eye drop administration
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    11 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age: 6-11 years Refractive error measured in spherical equivalent, one eye meets criterion 6 years old: 0.50 to +0.38 7 years old: 0.50 to +0.25 8-11 years old: 0.50 to plano Anisometropia: spherical equivalent <1.50 D Astigmatism: <1.50 in both eyes Myopia: Less myopic than -0.74 D, both eyes Exclusion Criteria: ● Myopic
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jeffrey J Walline, OD PhD
    Phone
    6142476840
    Email
    walline.1@osu.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lisa A Jordan, PhD
    Phone
    6142477321
    Email
    jordan.646@osu.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jeffrey J Walline, OD PhD
    Organizational Affiliation
    Ohio State University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Delaying the Onset of Nearsightedness Until Treatment Study

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