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Delaying the Onset of Nearsightedness Until Treatment Study (DONUT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06029530
Recruitment Status : Withdrawn (sIRB determined feasibility study could not be done because of no benefits of the treatment drops in short time violated FDA requirements)
First Posted : September 8, 2023
Last Update Posted : April 16, 2024
Sponsor:
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

Study Description
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Brief Summary:
Participants eligible for the study will be randomized to one of three concentrations of atropine and followed for a month.

Condition or disease Intervention/treatment Phase
Myopia Drug: Atropine Ophthalmic Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Official Title: Delaying the Onset of Nearsightedness Until Treatment Study
Estimated Study Start Date : January 1, 2024
Estimated Primary Completion Date : August 31, 2024
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Compliance percentage [ Time Frame: 30 days ]
    A comparison of the compliance percentage with eye drop administration


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06029530


Sponsors and Collaborators
Ohio State University
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
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Study Chair: Jeffrey J Walline, OD PhD Ohio State University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Jeffrey J. Walline, OD PhD, Associate Dean for Research, College of Optometry, Ohio State University
ClinicalTrials.gov Identifier: NCT06029530    
Other Study ID Numbers: DONUT
First Posted: September 8, 2023    Key Record Dates
Last Update Posted: April 16, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases
Atropine
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action