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New treatment option for Myopia
Official title Delaying the Onset of Nearsightedness Until Treatment (DONUT) Clinical Trial
ClinicalTrials.gov ID: NCT07567040
What this study is testing
What is Atropine Sulfate 0.05% Oph Soln?
Atropine Sulfate 0.05% Oph Soln is an investigational medicine, being studied as a potential treatment for myopia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 11. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- Ocular disease (e.g., congenital glaucoma, retinal disease, nystagmus, amblyopia, etc.)
- Ocular surgery (e.g., cataracts, strabismus)
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Berkeley, California, United States
- Fullerton, California, United States
- Palo Alto, California, United States
- Chicago, Illinois, United States
- Bloomington, Indiana, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Elkins Park, Pennsylvania, United States
- Memphis, Tennessee, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 11 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Berkeley, California, United States; Fullerton, California, United States; Palo Alto, California, United States; Chicago, Illinois, United States; Bloomington, Indiana, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.