Delaying the Onset of Nearsightedness Until Treatment Study (DONUT)

• ClinicalTrials.gov Identifier: NCT06029530
• Recruitment Status: Withdrawn
• First Posted: September 8, 2023
• Last Update Posted: April 16, 2024
• Sponsor: Ohio State University
• Collaborators: University of Houston; State University of New York; Pennsylvania College of Optometry; Southern California College of Optometry at Marshall B. Ketchum University; University of California, Berkeley; Stanford University; Case Western Reserve University; Illinois College of Optometry; Indiana University; New England College of Optometry; University of the Incarnate Word; Southern College of Optometry; University of Missouri, St. Louis
• Information provided by (Responsible Party): Jeffrey J. Walline, OD PhD, Ohio State University

Tracking Information

• First Submitted Date: August 24, 2023
• First Posted Date: September 8, 2023
• Last Update Posted Date: April 16, 2024
• Estimated Study Start Date: January 1, 2024
• Estimated Primary Completion Date: August 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 31, 2023)

Compliance percentage [ Time Frame: 30 days ]

A comparison of the compliance percentage with eye drop administration

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Delaying the Onset of Nearsightedness Until Treatment Study
• Official Title: Delaying the Onset of Nearsightedness Until Treatment Study
• Brief Summary: Participants eligible for the study will be randomized to one of three concentrations of atropine and followed for a month.
• 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
• Study Phase: Phase 1

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Participants will receive one of three concentrations of atropine (0.01%, 0.03%, or 0.05%)

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

De-identified bottles will be sent to the sites with randomization codes. The key will be kept at the data coordinating center.

Primary Purpose: Other

• Condition: Myopia

Intervention

Drug: Atropine Ophthalmic

eye drops to be administered once daily

Study Arms

• Active Comparator: 0.01% Atropine
  0.01% atropine eye drops
  Intervention: Drug: Atropine Ophthalmic
• Active Comparator: 0.03% Atropine
  0.03% atropine eye drops
  Intervention: Drug: Atropine Ophthalmic
• Active Comparator: 0.05% atropine
  0.05% atropine eye drops
  Intervention: Drug: Atropine Ophthalmic

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: April 12, 2024): 0
• Original Estimated Enrollment (submitted: August 31, 2023): 70
• Estimated Study Completion Date: August 31, 2024
• Estimated Primary Completion Date: August 31, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years to 11 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT06029530
• Other Study ID Numbers: DONUT
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Jeffrey J. Walline, OD PhD, Ohio State University
• Original Responsible Party: Same as current
• Current Study Sponsor: Ohio State University
• Original Study Sponsor: Same as current

Collaborators

• University of Houston
• State University of New York
• Pennsylvania College of Optometry
• Southern California College of Optometry at Marshall B. Ketchum University
• University of California, Berkeley
• Stanford University
• Case Western Reserve University
• Illinois College of Optometry
• Indiana University
• New England College of Optometry
• University of the Incarnate Word
• Southern College of Optometry
• University of Missouri, St. Louis

Investigators

• Study Chair: Jeffrey J Walline, OD PhD; Ohio State University

• PRS Account: Ohio State University
• Verification Date: April 2024