RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Ohio State University • ClinicalTrials.gov ID: NCT07567040

Registry updated: 2026-09-21

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Description

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.

Interventions

Atropine Sulfate 0.05% Oph Soln (Drug)
Atropine Sulfate 0.05% Oph Soln compounded at the pharmacy
Placebo (Drug)
Placebo drop with same formulation as treatment minus the atropine

Eligibility criteria

Inclusion Criteria: * Refractive Error (cycloplegic autorefraction, spherical equivalent, at least one eye, inclusive) 6 years: -0.74 D to +0.75 D 7 and 8 years: -0.74 D to +0.50 D 9 and 10 years: -0.74 D to +0.25 D 11 years: -0.74 D to plano * Neither eye has -0.75 D or more myopia, spherical component * Anisometropia: Less than 1.50 D difference between OD and OS, cycloplegic autorefraction, spherical equivalent * Astigmatism: Less than 1.50 DC in both eyes by cycloplegic autorefraction * Successfully complete run-in period: take at least 90% of unit dose artificial tears for 2 to 4 weeks (# of unit-dose vials used divided by # nights since baseline visit must equal 0.90 or greater) Exclusion Criteria: * If Visit 2 (randomization visit) is not completed within 4 weeks of the baseline, eligibility visit. * Presence of strabismus (intermittent or constant) based on unilateral cover test at distance and near * Known allergy to atropine * Systemic issues that may affect accommodation or convergence (e.g., multiple sclerosis, myasthenia gravis, Graves ophthalmopathy, diabetes mellitus, Parkinson's disease, Down syndrome, etc.) * Ocular disease (e.g., congenital glaucoma, retinal disease, nystagmus, amblyopia, etc.) * Ocular surgery (e.g., cataracts, strabismus) * Any previous myopia prevention/control therapy (e.g., atropine, soft contact lenses, orthokeratology, myopia control spectacles, etc.) for more than one month * Pregnancy by self-report

Conditions

Myopia

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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