Delaying the Onset of Nearsightedness Until Treatment Study

NCT06029530 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: DONUT
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Compliance percentage

  A comparison of the compliance percentage with eye drop administration

  30 days

Study Arms (3)

0.01% Atropine

ACTIVE COMPARATOR

0.01% atropine eye drops

Drug: Atropine Ophthalmic

0.03% Atropine

ACTIVE COMPARATOR

0.03% atropine eye drops

Drug: Atropine Ophthalmic

0.05% atropine

ACTIVE COMPARATOR

0.05% atropine eye drops

Drug: Atropine Ophthalmic

Interventions

Atropine Ophthalmic DRUG

eye drops to be administered once daily

0.01% Atropine; 0.03% Atropine; 0.05% atropine

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age: 6-11 years
• Refractive error measured in spherical equivalent, one eye meets criterion
• years old: 0.50 to +0.38
• years old: 0.50 to +0.25
• 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

You may not qualify if:

• ● Myopic

Sponsors & Collaborators

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

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Jeffrey J Walline, OD PhD

  Ohio State University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: De-identified bottles will be sent to the sites with randomization codes. The key will be kept at the data coordinating center.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean for Research, College of Optometry

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

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: September 8, 2023
• Study Start: January 1, 2024
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share