MyopiaPhase 4NCT06450132
Changes in Eye Shape With Myopia Management Interventions
A Phase 4 study testing Atropine Ophthalmic and MiSight 1-day disposable contact lenses in people with Myopia, run by Ohio State University at 1 site in United States.
Trial summary
The goal of this clinical trial is to study changes in eye shape of nearsighted young adults using low-dose atropine eye drops or soft multifocal contact lenses. The main questions it aims to answer are: do low-dose atropine and soft multifocal contact lenses affect the shape of the peripheral eye? are changes in… Read more about this study
- Who is it for?
- Ages 21 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Atropine Ophthalmic and MiSight 1-day disposable contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 31 Jul 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 21 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- best corrected visual acuity of 20/25 or better in each eye
- nearsighted
- current contact lens wearer
- normal binocular vision (to be determined by an examiner at the first study visit)
Who cannot join
- eye diseases (including lazy eye or eye turn)
- pregnant, nursing, or planning a pregnancy in the next 12 months
- history of refractive surgery (e.g., LASIK)
- history of myopia control treatment
- sensitivity to anesthetics or preservative in eye drops
- difficulty with pupillary dilation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Changes in Eye Shape in Young Adults Treated With Low-Dose Atropine and Soft Multifocal Contact Lenses
The goal of this clinical trial is to study changes in eye shape of nearsighted young adults using low-dose atropine eye drops or soft multifocal contact lenses. The main questions it aims to answer are:
- do low-dose atropine and soft multifocal contact lenses affect the shape of the peripheral eye?
- are changes in peripheral eye shape from these interventions influenced by changes in the focusing system of the eye?
Read more
Participants will:
- have multiple different types of photos taken
- have their prescription for glasses/contacts checked
- have their eye health checked, including the use of dilating eye drops
- be randomly assigned to use eye drops every night or wear special contact lenses daily instead of their typical contacts
- will complete five study visits over the course of 12 months
Researchers will compare young adults using low-dose atropine to those wearing soft multifocal contact lenses and to those using no intervention to see if using these interventions affects retinal shape.
- Conditions
- Myopia
- Being tested
- Atropine Ophthalmic, MiSight 1-day disposable contact lenses
- 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
0.05% atropine ophthalmic solution
MiSight 1-day disposable contact lensesDevice
soft multifocal contact lenses
| Study group | Role | What they receive |
|---|---|---|
| Observation | No intervention | Participants randomized to the observation arm will receive no intervention. |
| Low-dose atropine | Experimental | Participants randomized to low-dose atropine will instill one drop of 0.05% atropine in each eye at bedtime for 12 months. Receives: Drug: Atropine Ophthalmic |
| Soft multifocal contact lenses | Experimental | Participants randomized to soft multifocal contact lenses will wear MiSight 1-day disposable contact lenses for 5-7 days per week for 12 months. Receives: Device: MiSight 1-day disposable contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ocular shape
ocular shape, as measured by the ellipsoid fit of the retina acquired by the photos taken with ocular ultrasound (ABSolu, Quantel Medical)
Measured: baseline to 12 months
Secondary outcomes (3)
Axial elongation (or regression)
change in axial length of the eye, as measured by Lenstar 900 (Haag-Streit)
Measured: baseline to 12 months
Change in accommodative response
change in focusing ability of the eye, as measured with near targets and the Grand Seiko WR-5100K
Measured: baseline to 12 months
Change in refractive error
change in refractive error, as measured with the Grand Seiko WR-5100K
Measured: baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start1 Aug 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donald O Mutti, OD, PhD, Ohio State University
- Investigators
- Donald O Mutti, OD, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450132
- Sponsor's protocol ID
- 2023H0321
- Status last verified
- Jan 2026
- First submitted
- 4 Jun 2024
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Changes in Eye Shape in Young Adults Treated With Low-Dose Atropine and Soft Multifocal Contact Lenses
- ClinicalTrials.gov ID
- NCT06450132
- Acronym / sponsor ID
- 2023H0321
- Conditions
- Myopia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 10 Jun 2024 (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.
The goal of this clinical trial is to study changes in eye shape of nearsighted young adults using low-dose atropine eye drops or soft multifocal contact lenses. The main questions it aims to answer are:
- do low-dose atropine and soft multifocal contact lenses affect the shape of the peripheral eye?
- are changes in peripheral eye shape from these interventions influenced by changes in the focusing system of the eye?
Participants will:
- have multiple different types of photos taken
- have their prescription for glasses/contacts checked
- have their eye health checked, including the use of dilating eye drops
- be randomly assigned to use eye drops every night or wear special contact lenses daily instead of their typical contacts
- will complete five study visits over the course of 12 months
Researchers will compare young adults using low-dose atropine to those wearing soft multifocal contact lenses and to those using no intervention to see if using these interventions affects retinal shape.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Observation | No intervention | –Participants randomized to the observation arm will receive no intervention. |
| Low-dose atropine | Experimental | Drug: Atropine OphthalmicParticipants randomized to low-dose atropine will instill one drop of 0.05% atropine in each eye at bedtime for 12 months. |
| Soft multifocal contact lenses | Experimental | Device: MiSight 1-day disposable contact lensesParticipants randomized to soft multifocal contact lenses will wear MiSight 1-day disposable contact lenses for 5-7 days per week for 12 months. |
Who may qualify
- Ages
- 21 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- best corrected visual acuity of 20/25 or better in each eye
- nearsighted
- current contact lens wearer
- normal binocular vision (to be determined by an examiner at the first study visit)
Key exclusion criteria (6 listed)
- eye diseases (including lazy eye or eye turn)
- pregnant, nursing, or planning a pregnancy in the next 12 months
- history of refractive surgery (e.g., LASIK)
- history of myopia control treatment
- sensitivity to anesthetics or preservative in eye drops
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 Ophthalmic0.05% atropine ophthalmic solution | Drug | Low-dose atropine |
| MiSight 1-day disposable contact lensessoft multifocal contact lenses | Device | Soft multifocal contact lenses |
Primary outcome
Change in ocular shape
Time frame: baseline to 12 months
ocular shape, as measured by the ellipsoid fit of the retina acquired by the photos taken with ocular ultrasound (ABSolu, Quantel Medical)
3 secondary outcomes
Axial elongation (or regression)
Time frame: baseline to 12 months
Change in accommodative response
Time frame: baseline to 12 months
Change in refractive error
Time frame: baseline to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Myopia
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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.
Donald O Mutti, OD, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atropine Ophthalmic and MiSight 1-day disposable contact lenses in people with Myopia, run by Ohio State University at 1 site in United States.
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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Change in ocular shape (time frame: baseline to 12 months). 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 27 Jan 2026.