Recruiting
Phase 3

Atropine

Sponsor:

Ohio State University

Code:

NCT07567040

Conditions

Myopia

Eligibility Criteria

Sex: All

Age: 6 - 11

Healthy Volunteers: Accepted

Interventions

Atropine Sulfate 0.05% Oph Soln

Placebo

Study Details

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.

Conditions

Myopia

Study ID

NCT07567040

Start date

May 27, 2026

Status verified date

Aug, 2026

Completion date

May 15, 2028

Anticipated

Primary completion date

May 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 11

Healthy Volunteers: Accepted

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

Study Design

Enrollment

664 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 0.05% Atropine

0.05% atropine instilled in each eye nightly at bedtime

placebo comparator: Placebo

Placebo drops instilled in each eye nightly at bedtime

Interventions

Atropine Sulfate 0.05% Oph Soln

Atropine Sulfate 0.05% Oph Soln compounded at the pharmacy

Placebo

Placebo drop with same formulation as treatment minus the atropine

Primary outcome measure

  • Cumulative incidence of myopia (spherical equivalent by Myopia Master) [ Time Frame: Two years ]
  • Axial elongation (by Myopia Master) [ Time Frame: Two years ]

Central Contacts and Locations

Central contacts

Lisa A Jordan, PhD

614-247-7321jordan.646@osu.edu

Locations

University of Alabama School of Optometry

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Sindhu Gurrala

205-975-3881OPT-donutstudy@uab.edu

University of California, Berkeley, School of Optometry

Recruiting

Berkeley, California, United States, 94720

Contacts

Yoofi Mensah

510-207-4758donut@berkeley.edu

Southern California College of Optometry at Marshall B. Ketchum University

Recruiting

Fullerton, California, United States, 92831

Contacts

Susan Parker

714-463-7580research@ketchum.edu

Illinois College of Optometry

Recruiting

Chicago, Illinois, United States, 60616

Contacts

Jessica Martinez

312-949-7340Research@ico.edu

Indiana University

Recruiting

Bloomington, Indiana, United States, 47405

Contacts

Amy Peterson, OD

812-856-0242peteramy@iu.edu

New England College of Optometry

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Tamara Khanjyan

617-587-5723donutstudy@neco.edu

State University of New York College of Optometry

Recruiting

New York, New York, United States, 10036

Contacts

Keyana Hunte

212-938-4052clinicresearch@sunyopt.edu

The Ohio State University College of Optometry

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Alexis Koston

614-292-0200OPT-DonutStudy@osu.edu

Southern College of Optometry

Recruiting

Memphis, Tennessee, United States, 38104

Contacts

Elaine Turcotte

901-730-5004eturcotte@sco.edu

University of Houston College of Optometry

Recruiting

Houston, Texas, United States, 77004

Contacts

Onose Okoeguale

713-743-1994donut@uh.edu

More Information

Sponsor

Ohio State University

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

  • prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-08-21.