MyopiaPhase 3DONUTNCT07567040
Delaying the Onset of Nearsightedness Until Treatment (DONUT) Clinical Trial
A Phase 3 study testing Atropine Sulfate 0.05% Oph Soln in people with Myopia, run by Ohio State University at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Atropine Sulfate 0.05% Oph Soln
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 664 participants
- Where
- 13 sitesUnited States
- Study dates
- 27 May 2026to 15 May 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 13 recruiting
- Recruiting
University of California, Berkeley, School of Optometry
Berkeley, California, 94720
Yoofi Mensah, 510-207-4758, donut@berkeley.edu
- Recruiting
University of Alabama School of Optometry
Birmingham, Alabama, 35233
Sindhu Gurrala, 205-975-3881, OPT-donutstudy@uab.edu
- Recruiting
Indiana University
Bloomington, Indiana, 47405
Amy Peterson, OD, 812-856-0242, peteramy@iu.edu
- Recruiting
New England College of Optometry
Boston, Massachusetts, 02115
Tamara Khanjyan, 617-587-5723, donutstudy@neco.edu
- Recruiting
Illinois College of Optometry
Chicago, Illinois, 60616
Jessica Martinez, 312-949-7340, Research@ico.edu
- Not yet recruiting
Case Western Reserve Department of Ophthalmology
Cleveland, Ohio, 44106
Adam J Peiffer, OD, 440-684-1743, adam.peiffer@uhhospitals.org
- Recruiting
The Ohio State University College of Optometry
Columbus, Ohio, 43210
Alexis Koston, 614-292-0200, OPT-DonutStudy@osu.edu
- Recruiting
Pennsylvania College of Optometry at Drexel University
Elkins Park, Pennsylvania, 19027
Asami Kojima, 215-276-6053, donutstudy@drexel.edu
- Recruiting
Southern California College of Optometry at Marshall B. Ketchum University
Fullerton, California, 92831
Susan Parker, 714-463-7580, research@ketchum.edu
- Recruiting
University of Houston College of Optometry
Houston, Texas, 77004
Onose Okoeguale, 713-743-1994, donut@uh.edu
- Recruiting
Southern College of Optometry
Memphis, Tennessee, 38104
Elaine Turcotte, 901-730-5004, eturcotte@sco.edu
- Recruiting
State University of New York College of Optometry
New York, New York, 10036
Keyana Hunte, 212-938-4052, clinicresearch@sunyopt.edu
- Recruiting
Stanford University
Palo Alto, California, 94303
Joellen Leonard, 650-498-0842, Robertsvisionlab@stanford.edu
About this study
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.
Read the detailed description
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.
- Conditions
- Myopia
- Being tested
- Atropine Sulfate 0.05% Oph Soln, Placebo
- Keywords
- prevention
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atropine Sulfate 0.05% Oph SolnDrug
Atropine Sulfate 0.05% Oph Soln compounded at the pharmacy
PlaceboDrug
Placebo drop with same formulation as treatment minus the atropine
| Study group | Role | What they receive |
|---|---|---|
| 0.05% Atropine | Experimental | 0.05% atropine instilled in each eye nightly at bedtime Receives: Drug: Atropine Sulfate 0.05% Oph Soln |
| Placebo | Placebo comparator | Placebo drops instilled in each eye nightly at bedtime Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of myopia (spherical equivalent by Myopia Master)
Cumulative incidence of myopia as measured by cycloplegic autorefraction comparison between treatment and placebo
Measured: Two years
Axial elongation (by Myopia Master)
Axial elongation comparison between treatment and placebo
Measured: Two years
Secondary outcomes (2)
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
Measured: 2 years
Progression of spherical equivalent (by Myopia Master)
Spherical equivalent progression (change) comparison between treatment and placebo
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start27 May 2026
- Primary completion15 May 2028 (estimated)
- Study completion15 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo-controlled randomized clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 664 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- David A Berntsen, OD PhD, Study chair, University of Houston College of OptometryJeffrey J Walline, OD PhD, Study chair, The Ohio State University College of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07567040
- Sponsor's protocol ID
- DONUTCT
- Other IDs
- UG1EY037202, UG1EY037201
- Acronym
- DONUT
- Status last verified
- Sep 2026
- First submitted
- 28 Apr 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delaying the Onset of Nearsightedness Until Treatment (DONUT) Clinical Trial
- ClinicalTrials.gov ID
- NCT07567040
- Acronym / sponsor ID
- DONUT / DONUTCT
- Conditions
- Myopia
- Keywords
- prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 664 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 27 May 2026 (actual)
- Primary completion
- 15 May 2028 (estimated)
- Study completion
- 15 May 2028 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Placebo-controlled randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| 0.05% Atropine | Experimental | Drug: Atropine Sulfate 0.05% Oph Soln0.05% atropine instilled in each eye nightly at bedtime |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo drops instilled in each eye nightly at bedtime |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atropine Sulfate 0.05% Oph SolnAtropine Sulfate 0.05% Oph Soln compounded at the pharmacy | Drug | 0.05% Atropine |
| PlaceboPlacebo drop with same formulation as treatment minus the atropine | Drug | Placebo |
Primary outcome
Cumulative incidence of myopia (spherical equivalent by Myopia Master)
Time frame: Two years
Cumulative incidence of myopia as measured by cycloplegic autorefraction comparison between treatment and placebo
Axial elongation (by Myopia Master)
Time frame: Two years
Axial elongation comparison between treatment and placebo
2 secondary outcomes
Time to event in incident myopes (measured by spherical equivalent by Myopia Master)
Time frame: 2 years
Progression of spherical equivalent (by Myopia Master)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David A Berntsen, OD PhD study chair
University of Houston College of Optometry
Jeffrey J Walline, OD PhD study chair
The Ohio State University College of Optometry
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atropine Sulfate 0.05% Oph Soln in people with Myopia, run by Ohio State University at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa A Jordan, PhD (614-247-7321, jordan.646@osu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of myopia (spherical equivalent by Myopia Master) (time frame: Two years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.