DONUT: Delaying the Onset of Nearsightedness Until Treatment Study

Sponsor

Ohio State University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06029530

Collaborator

University of Houston (Other), State University of New York (Other), Pennsylvania College of Optometry (Industry), Southern California College of Optometry at Marshall B. Ketchum University (Other), University of California, Berkeley (Other), Stanford University (Other), Case Western Reserve University (Other), Illinois College of Optometry (Other), Indiana University (Other), New England College of Optometry (Other), University of the Incarnate Word (Other), Southern College of Optometry (Other), University of Missouri, St. Louis (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Participants eligible for the study will be randomized to one of three concentrations of atropine and followed for a month.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Drug: Atropine Ophthalmic	Phase 1

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%).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants will receive one of three concentrations of atropine (0.01%, 0.03%, or 0.05%)Participants will receive one of three concentrations of atropine (0.01%, 0.03%, or 0.05%)

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes 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.

Primary Purpose:

Other

Official Title:

Delaying the Onset of Nearsightedness Until Treatment Study

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Aug 31, 2024

Anticipated Study Completion Date :

Aug 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 0.01% Atropine 0.01% atropine eye drops	Drug: Atropine Ophthalmic eye drops to be administered once daily
Active Comparator: 0.03% Atropine 0.03% atropine eye drops	Drug: Atropine Ophthalmic eye drops to be administered once daily
Active Comparator: 0.05% atropine 0.05% atropine eye drops	Drug: Atropine Ophthalmic eye drops to be administered once daily

Arm

Intervention/Treatment

Active Comparator: 0.01% Atropine

0.01% atropine eye drops

Drug: Atropine Ophthalmic

eye drops to be administered once daily

Active Comparator: 0.03% Atropine

0.03% atropine eye drops

Drug: Atropine Ophthalmic

eye drops to be administered once daily

Active Comparator: 0.05% atropine

0.05% atropine eye drops

Drug: Atropine Ophthalmic

eye drops to be administered once daily

Outcome Measures

Primary Outcome Measures

Compliance percentage [30 days]
A comparison of the compliance percentage with eye drop administration

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 11 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ohio State University
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

Investigators

Study Chair: Jeffrey J Walline, OD PhD, Ohio State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jeffrey J. Walline, OD PhD, Associate Dean for Research, College of Optometry, Ohio State University

ClinicalTrials.gov Identifier:

NCT06029530

Other Study ID Numbers:

DONUT

First Posted:

Sep 8, 2023

Last Update Posted:

Sep 8, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Myopia

Atropine

Study Results

No Results Posted as of Sep 8, 2023