MyopiaPhase 1DONUTNCT06029530
Delaying the Onset of Nearsightedness Until Treatment Study
A Phase 1 study testing Atropine Ophthalmic in people with Myopia, run by Ohio State University.
Trial summary
Participants eligible for the study will be randomized to one of three concentrations of atropine and followed for a month. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Atropine Ophthalmic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 31 Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- ● Myopic
About this study
Participants eligible for the study will be randomized to one of three concentrations of atropine and followed for a month.
Read the 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%).
- Conditions
- Myopia
- Being tested
- Atropine Ophthalmic
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atropine OphthalmicDrug
eye drops to be administered once daily
| Study group | Role | What they receive |
|---|---|---|
| 0.01% Atropine | Active comparator | 0.01% atropine eye drops Receives: Drug: Atropine Ophthalmic |
| 0.03% Atropine | Active comparator | 0.03% atropine eye drops Receives: Drug: Atropine Ophthalmic |
| 0.05% atropine | Active comparator | 0.05% atropine eye drops Receives: Drug: Atropine Ophthalmic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance percentage
A comparison of the compliance percentage with eye drop administration
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start1 Jan 2024 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Why it stopped: sIRB determined feasibility study could not be done because of no benefits of the treatment drops in short time violated FDA requirements
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will receive one of three concentrations of atropine (0.01%, 0.03%, or 0.05%)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Jeffrey J. Walline, OD PhD, Ohio State University
- Investigators
- Jeffrey J Walline, OD PhD, Study chair, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029530
- Sponsor's protocol ID
- DONUT
- Acronym
- DONUT
- Status last verified
- Apr 2024
- First submitted
- 24 Aug 2023
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delaying the Onset of Nearsightedness Until Treatment Study
- ClinicalTrials.gov ID
- NCT06029530
- Acronym / sponsor ID
- DONUT / DONUT
- Conditions
- Myopia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: sIRB determined feasibility study could not be done because of no benefits of the treatment drops in short time violated FDA requirements
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- 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
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 8 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will receive one of three concentrations of atropine (0.01%, 0.03%, or 0.05%)
| Arm | Type | Receives |
|---|---|---|
| 0.01% Atropine | Active comparator | Drug: Atropine Ophthalmic0.01% atropine eye drops |
| 0.03% Atropine | Active comparator | Drug: Atropine Ophthalmic0.03% atropine eye drops |
| 0.05% atropine | Active comparator | Drug: Atropine Ophthalmic0.05% atropine eye drops |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age: 6-11 years
- Refractive error measured in spherical equivalent, one eye meets criterion
- Anisometropia: spherical equivalent <1.50 D
- Astigmatism: <1.50 in both eyes
- Myopia: Less myopic than -0.74 D, both eyes
Key exclusion criteria (1 listed)
- ● Myopic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atropine Ophthalmiceye drops to be administered once daily | Drug | 0.01% Atropine, 0.03% Atropine, 0.05% atropine |
Primary outcome
Compliance percentage
Time frame: 30 days
A comparison of the compliance percentage with eye drop administration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey J Walline, OD PhD study chair
Ohio State University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Atropine Ophthalmic in people with Myopia, run by Ohio State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance percentage (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.