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Delaying the Onset of Nearsightedness Until Treatment (DONUT) Clinical Trial

NCT07567040 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 664

Last updated 2026-05-08

No results posted yet for this study

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

Interventions

DRUG

Atropine Sulfate 0.05% Oph Soln

Atropine Sulfate 0.05% Oph Soln compounded at the pharmacy

DRUG

Placebo

Placebo drop with same formulation as treatment minus the atropine

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • Ohio State University

    lead OTHER

Principal Investigators

  • David A Berntsen, OD PhD · University of Houston College of Optometry

  • Jeffrey J Walline, OD PhD · The Ohio State University College of Optometry

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-06
Primary Completion
2028-05-15
Completion
2028-05-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07567040 on ClinicalTrials.gov