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DONUT: Atropine for Delaying the Onset of Nearsightedness in Children
NCT07567040Phase 3
Key facts
- Status
- Recruiting
- Start
- May 2026
- Primary completion
- May 2028
- Countries
- 1
- Sponsor
- The Ohio State University
- Modality
- Classical Binding Small Molecules
- Drugs
- NVK002
- Conditions
- myopia
01
Overview
Phase 3, randomised, double-blind trial of NVK002 in myopia (2 arms), sponsored by The Ohio State University. Primary endpoints: Cumulative incidence of myopia at 2 years and Axial elongation at 2 years. Started May 2026; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
0.05% Atropine
0.05% atropine instilled in each eye nightly at bedtime
Placebo
Placebo drops instilled in each eye nightly at bedtime
03
Who it enrols
Children aged 6-11 at high risk of myopia onset, without current myopia, strabismus, or prior myopia control therapy.
04
Endpoints
Primary
Cumulative incidence of myopia
Axial elongation
Secondary
Time to event in incident myopes
Progression of spherical equivalent
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