NCT07567040 Delaying the Onset of Nearsightedness Until Treatment (DONUT) Clinical Trial
| NCT ID | NCT07567040 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Ohio State University |
| Condition | Myopia |
| Study Type | INTERVENTIONAL |
| Enrollment | 664 participants |
| Start Date | 2026-05-06 |
| Primary Completion | 2028-05-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 664 participants in total. It began in 2026-05-06 with a primary completion date of 2028-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
David A Berntsen, OD PhD
STUDY CHAIR
University of Houston College of Optometry
Frequently Asked Questions
Who can join the NCT07567040 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 11 Years, studying Myopia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07567040 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 664 participants.
Is NCT07567040 currently recruiting?
Yes, NCT07567040 is actively recruiting participants. Contact the research team at jordan.646@osu.edu for enrollment information.
Where is the NCT07567040 trial being conducted?
This trial is being conducted at Birmingham, United States, Berkeley, United States, Fullerton, United States, Palo Alto, United States and 10 additional locations.
Who is sponsoring the NCT07567040 clinical trial?
NCT07567040 is sponsored by Ohio State University. The principal investigator is David A Berntsen, OD PhD at University of Houston College of Optometry. The trial plans to enroll 664 participants.