Delaying the Onset of Nearsightedness Until Treatment Study (DONUT)

Participants eligible for the study will be randomized to one of three concentrations of atropine and followed for a month.

Study Overview

• Status: Withdrawn
• Conditions: Myopia
• Intervention / Treatment: Drug: Atropine Ophthalmic

Detailed Description

Participants will be identified through screening that fit the criteria of a pre-myopic child, which will depend on age and the amount of refractive error at that time. These children will be randomized for a pilot study measuring compliance in nightly eye drop administration. The outcome will be thirty days after randomization, and will assess whether or not there is a difference in compliance between one of three dosages of atropine (0.01%, 0.03%, and 0.05%).

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age: 6-11 years

• Refractive error measured in spherical equivalent, one eye meets criterion

  • 6 years old: 0.50 to +0.38
  • 7 years old: 0.50 to +0.25
  • 8-11 years old: 0.50 to plano
• Anisometropia: spherical equivalent <1.50 D
• Astigmatism: <1.50 in both eyes
• Myopia: Less myopic than -0.74 D, both eyes

Exclusion Criteria:

● Myopic

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 0.01% Atropine; 0.01% atropine eye drops	Drug: Atropine Ophthalmic; eye drops to be administered once daily
Active Comparator: 0.03% Atropine; 0.03% atropine eye drops	Drug: Atropine Ophthalmic; eye drops to be administered once daily
Active Comparator: 0.05% atropine; 0.05% atropine eye drops	Drug: Atropine Ophthalmic; eye drops to be administered once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance percentage	A comparison of the compliance percentage with eye drop administration	30 days

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: University of California, Berkeley; Stanford University; University of Houston; Indiana University; Case Western Reserve University; Southern California College of Optometry at Marshall B. Ketchum University; University of the Incarnate Word; State University of New York; Southern College of Optometry; Illinois College of Optometry; New England College of Optometry; Pennsylvania College of Optometry; University of Missouri, St. Louis
• Investigators: Study Chair: Jeffrey J Walline, OD PhD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: August 24, 2023
• First Submitted That Met QC Criteria: August 31, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Adjuvants, Anesthesia; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Mydriatics; Atropine
• Other Study ID Numbers: DONUT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No