RecruitingPhase 3NCT07567040

Delaying the Onset of Nearsightedness Until Treatment (DONUT) Clinical Trial

Sponsor

Ohio State University

Enrollment

664 participants

Start Date

May 27, 2026

Study Type

INTERVENTIONAL

Conditions

Myopia

Summary

The aims of this clinical trial will test whether or not the onset of nearsightedness is delayed in a group of children randomized to nightly drops in 0.05% atropine in both eyes, in comparison to children who receiving nightly placebo drops in both eyes. The primary outcome is the two-year cumulative incidence of nearsightedness. The second aim of this project will determine whether atropine is associated with slower eye growth in children receiving nightly drops of atropine versus placebo.

Eligibility

Min Age: 6 YearsMax Age: 11 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Atropine Sulfate 0.05% Oph Soln and a drug called Placebo for people with myopia. The study is currently recruiting participants at 14 locations. People eligible for this study include aged 6 Years to 11 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAtropine Sulfate 0.05% Oph Soln

Atropine Sulfate 0.05% Oph Soln compounded at the pharmacy

DRUGPlacebo

Placebo drop with same formulation as treatment minus the atropine

Locations(14)

University of Alabama School of Optometry

Birmingham, Alabama, United States

University of California, Berkeley, School of Optometry

Berkeley, California, United States

Southern California College of Optometry at Marshall B. Ketchum University

Fullerton, California, United States

Stanford University

Palo Alto, California, United States

Illinois College of Optometry

Chicago, Illinois, United States

Indiana University

Bloomington, Indiana, United States

New England College of Optometry

Boston, Massachusetts, United States

State University of New York College of Optometry

New York, New York, United States

Case Western Reserve Department of Ophthalmology

Cleveland, Ohio, United States

The Ohio State University College of Optometry

Columbus, Ohio, United States

Pennsylvania College of Optometry at Drexel University

Elkins Park, Pennsylvania, United States

Southern College of Optometry

Memphis, Tennessee, United States

University of Houston College of Optometry

Houston, Texas, United States

Rosenberg College of Optometry at the University of Incarnate Word

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07567040

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