A Phase 3 interventional study of Atropine Sulfate 0.05% Oph Soln and Placebo in Myopia, sponsored by Ohio State University. Recruiting at 13 sites in United States. Open to participants aged 6 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Ohio State University · Phase 3, Interventional, and Prevention
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.
The "Delaying the Onset of Nearsightedness (DONUT) Study - Data Coordinating Center" is a randomized clinical trial designed to compare the effectiveness 0.05% atropine and a placebo in delaying the onset of nearsightedness. It is a multicenter (14 clinic centers) randomized clinical trial of 606 children (recruited over two years) ages 6 to 11 years who are determine to be at high risk of myopia onset, as measured by cycloplegic autorefraction and age. The primary outcome is the two-year cumulative incidence of myopia. The second aim of this project will determine whether atropine is associated with slower axial elongation in children receiving nightly drops of atropine versus placebo.
Participants will be seen every six months for at least two years to determine the onset of myopia.
1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.
This study's planned enrollment of 664 is above the median of 78 across 923 interventional studies indexed under Myopia.
Browse Myopia studies →Ohio State University is the lead sponsor of 663 studies on the registry; 148 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 49 (73%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
0.05% atropine instilled in each eye nightly at bedtime
Drug: Atropine Sulfate 0.05% Oph Soln
Placebo drops instilled in each eye nightly at bedtime
Drug: Placebo
Atropine Sulfate 0.05% Oph Soln compounded at the pharmacy
Placebo drop with same formulation as treatment minus the atropine
Cumulative incidence of myopia (spherical equivalent by Myopia Master)
Cumulative incidence of myopia as measured by cycloplegic autorefraction comparison between treatment and placebo
Time frame: Two years
Axial elongation (by Myopia Master)
Axial elongation comparison between treatment and placebo
Time frame: Two years
Time to event in incident myopes (measured by spherical equivalent by Myopia Master)
A comparison of the time to myopia onset between the treatment and placebo groups
Time frame: 2 years
Progression of spherical equivalent (by Myopia Master)
Spherical equivalent progression (change) comparison between treatment and placebo
Time frame: 2 years
Plan to share: Yes — The final dataset to be shared will include self-reported demographic and participant activity and compliance to treatment data from interviews with participants' parent or guardian, eye examination data, and refraction data. The investigators will share de-identified individual-participant level (IPD) data. Appropriate measures such as providing only participant age and not providing clinical site of data collection will be used for data de-identification and sharing, and informed consent forms will reflect those plans. Calculated fields, rather than the component fields, will be available for a more accessible dataset.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Shared data generated from this project will be made available as soon as possible, and no later than the time of publication or the end of the funding period, whichever comes first. The duration of preservation and sharing of the data will be a minimum of 10 years after the contribution of the data to Vivli.
Access criteria: Data will be available for access on Vivli.
No publications or documents are linked to this record.
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Studies of the drug tested here: Atropine