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
About this trial
This is an interventional other trial for Myopia
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
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
NCT ID
NCT06029530
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
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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