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

Inclusion Criteria:

• Refractive Error (cycloplegic autorefraction, spherical equivalent, at least oneeye, 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, cycloplegicautorefraction, 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 tearsfor 2 to 4 weeks (# of unit-dose vials used divided by # nights since baseline visitmust 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 atdistance and near

• Known allergy to atropine

• Systemic issues that may affect accommodation or convergence (e.g., multiplesclerosis, myasthenia gravis, Graves ophthalmopathy, diabetes mellitus, Parkinson'sdisease, 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