MyopiaPhase 3NCT03942419
Microdosed Atropine 0.1% and 0.01% Ophthalmic Solutions for Reduction of Pediatric Myopia Progression
A Phase 3 study testing Atropine 0.1% Ophthalmic Solution and Atropine 0.01% Ophthalmic Solution in people with Myopia, run by Eyenovia Inc. at 18 sites in United States.
Trial summary
This study evaluates the progression of myopia in participants using microdosed atropine 0.01%, atropine 0.1%, or placebo ophthalmic solution. Eligible subjects will administer study medication daily in each eye for 48 months. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Myopia
- What is being tested?
- Atropine 0.1% Ophthalmic Solution and Atropine 0.01% Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 438 participants
- Where
- 18 sitesUnited States
- Study dates
- 3 Jun 2019to 20 Nov 2024
- Phase
- Phase 3
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Refractive error by cycloplegic autorefraction: myopia -1.00 D to -6.00 D in both eyes; astigmatism ≤ 1.50 D in both eyes; anisometropia < 1.50 D.
- Best-corrected distance visual acuity in current correction of 0.2 logMAR or better with interocular difference ≤ 0.1 logMAR.
- Refractive correction for each eye meets the following criteria: myopia within ± 0.50 D of the manifest refraction at the Screening Visit; cylinder power within ± 0.50 D of the manifest refraction at the Screening Visit; when cylinder power is < 1.00 D, axis within ± 15 degrees of the manifest refraction; when cylinder power is ≥ 1.00 D, axis within ± 5 degrees of the manifest refraction.
Who cannot join
- Current or previous myopia treatment with non-study atropine, pirenzepine or other topical anti-muscarinic agent.
- Current use of bifocals, progressive-addition lenses, or multifocal soft contact lenses.
- Use of rigid gas permeable lenses, including orthokeratology lenses within 90 days of Screening.
- Known atropine allergy.
- Abnormality of the cornea, lens, central retina, iris or ciliary body.
- Current or prior history of manifest strabismus, amblyopia, or nystagmus.
Show all 20Show fewer
- Prior eyelid, strabismus, intraocular, or refractive surgery.
- Intraocular pressure > 26 mmHg.
- History of premature birth by parent's report.
- Inability to perform protocol-prescribed testing due to preexisting neurological diagnoses, genetic syndrome, or other issues.
- Medical conditions predisposing patient to degenerative myopia, abnormal ocular refractive anatomy, and/or any history of intraocular surgery.
- Any systemic disease or condition that may affect visual function or development such as diabetes mellitus.
- Any ocular inflammation or external ocular inflammation within 30 days of Screening.
- History of punctal occlusion.
- Heterochromia.
- Lid squeezers.
- Participation in any study of an investigational, interventional product within 30 days prior to Screening Visit.
- Immediate family member of study staff designed to perform study evaluations or procedures.
- Pregnancy, or if sexually active, unwillingness to use an acceptable form of contraception during the study.
- Presence of a severe/serious ocular condition or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment or follow-up.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Canyon City Eyecare
Azusa, California, 91702
UC Berkeley
Berkeley, California, 94720
University of Alabama at Birmingham School of Optometry
Birmingham, Alabama, 35294
Primary Eyecare Group
Brentwood, Tennessee, 37027
Illinois College of Optometry
Chicago, Illinois, 60616
The Ohio State University - College of Optometry
Columbus, Ohio, 43210
Scott & Christie and Associates
Cranberry Township, Pennsylvania, 16066
Midwestern University
Downers Grove, Illinois, 60515
Midwestern University
Glendale, Arizona, 85308
Wake Forest Health Network Ophthalmology - Oak Hollow
High Point, North Carolina, 27262
Marshall Ketchum University College of Optometry
Los Angeles, California, 90037
Southern College of Optometry
Memphis, Tennessee, 38104
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
SUNY College of Optometry
New York, New York, 10036
Salus University - The Eye Institute
Philadelphia, Pennsylvania, 19141
Oculus Research
Raleigh, North Carolina, 27603
Ratner Children's Eye Center
San Diego, California, 92093
Virginia Pediatric Eye Center
Virginia Beach, Virginia, 23452
About this study
Official title: A Multicenter, Double-Masked, Randomized, Placebo-Controlled Phase 3 Study of the Safety and Efficacy of Atropine 0.1% and 0.01% Ophthalmic Solutions Administered With a Microdose Dispenser for the Reduction of Pediatric Myopia Progression (The CHAPERONE Study)
This study evaluates the progression of myopia in participants using microdosed atropine 0.01%, atropine 0.1%, or placebo ophthalmic solution. Eligible subjects will administer study medication daily in each eye for 48 months. Efficacy and safety assessments will be performed at visits scheduled for 1, 6, 12, 18, 24, 30 and 36 months after initiation of medication use. Subjects will be re-randomized at the 36 month visit, then followed at 6 month intervals for an additional year.
Read the detailed description
Subjects will be evaluated for eligibility during an initial Screening Visit and enrolled after signing the study-specific informed consent form(s). Eligible subjects must complete a run-in period where they use the microdose dispenser to administer study drug "vehicle" solution daily in both eyes. After run-in, subjects return for a Baseline Visit and additional study eligibility assessments. Subjects who continue to be eligible will be equally randomized to one of the following treatment groups:
- Microdose atropine 0.1% ophthalmic solution
- Microdose atropine 0.01% ophthalmic solution
- Microdose placebo ophthalmic solution
Randomization will be stratified by iris color (e.g., dark and light) and study site. Study enrollment will be limited to a maximum of 50% of subjects who self-identify as East Asian ethnicity. Subjects will use their assigned study medication daily in both eyes and return for efficacy and safety assessments at 1, 6, 12, 18, 24, 30, and 36 months.
At the Month 36 Visit, subjects in the 2 atropine dose arms will be re-randomized to either placebo or 1 of the 2 doses of atropine ophthalmic solution, while subjects originally assigned to placebo will be re-randomized to one of the 2 atropine ophthalmic solution arms. After re-randomization, all subjects will be followed for an additional year with efficacy and safety examinations at Months 42 and 48.
- Conditions
- Myopia
- Being tested
- Atropine 0.1% Ophthalmic Solution, Atropine 0.01% Ophthalmic Solution, Placebo Ophthalmic Solution
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atropine 0.1% Ophthalmic SolutionDrug
Atropine 0.1% ophthalmic solution administered with a microdose dispenser
Atropine 0.01% Ophthalmic SolutionDrug
Atropine 0.01% ophthalmic solution administered with a microdose dispenser
Placebo Ophthalmic SolutionDrug
Placebo ophthalmic solution administered with a microdose dispenser
| Study group | Role | What they receive |
|---|---|---|
| Atropine 0.1% Ophthalmic Solution | Experimental | Atropine 0.1% ophthalmic solution administered daily in both eyes using a microdose dispenser Receives: Drug: Atropine 0.1% Ophthalmic Solution |
| Atropine 0.01% Ophthalmic Solution | Experimental | Atropine 0.01% ophthalmic solution administered daily in both eyes using a microdose dispenser Receives: Drug: Atropine 0.01% Ophthalmic Solution |
| Placebo Ophthalmic Solution | Placebo comparator | Placebo ophthalmic solution administered daily in both eyes using a microdose dispenser Receives: Drug: Placebo Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myopia progression
The proportion of primary study eyes showing less than 0.50 D (spherical equivalent) myopia progression compared to baseline measured using cycloplegic autorefraction.
Measured: 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start3 Jun 2019
- Primary completion31 Oct 2024
- Study completion20 Nov 2024
Why it stopped: Interim Analysis reviewed by Data Monitoring Committee indicated futility
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multi-center, double masked, randomized, placebo-controlled study evaluating the efficacy of microdosed atropine 0.01%, atropine 0.1% and placebo ophthalmic solutions. Subjects will administer their assigned medication daily in both eyes for 36 months, then be re-randomized to the same or an alternative treatment arm and followed for an additional 12 months.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 438 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eyenovia Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942419
- Sponsor's protocol ID
- EYN-MYO-AT-31
- Status last verified
- Jan 2025
- First submitted
- 7 May 2019
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Masked, Randomized, Placebo-Controlled Phase 3 Study of the Safety and Efficacy of Atropine 0.1% and 0.01% Ophthalmic Solutions Administered With a Microdose Dispenser for the Reduction of Pediatric Myopia Progression (The CHAPERONE Study)
- ClinicalTrials.gov ID
- NCT03942419
- Acronym / sponsor ID
- EYN-MYO-AT-31
- Conditions
- Myopia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim Analysis reviewed by Data Monitoring Committee indicated futility
- Enrolment
- 438 participants (actual)
- Lead sponsor
- Eyenovia Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 8 May 2019 (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.
This study evaluates the progression of myopia in participants using microdosed atropine 0.01%, atropine 0.1%, or placebo ophthalmic solution. Eligible subjects will administer study medication daily in each eye for 48 months. Efficacy and safety assessments will be performed at visits scheduled for 1, 6, 12, 18, 24, 30 and 36 months after initiation of medication use. Subjects will be re-randomized at the 36 month visit, then followed at 6 month intervals for an additional year.
Detailed description
Subjects will be evaluated for eligibility during an initial Screening Visit and enrolled after signing the study-specific informed consent form(s). Eligible subjects must complete a run-in period where they use the microdose dispenser to administer study drug "vehicle" solution daily in both eyes. After run-in, subjects return for a Baseline Visit and additional study eligibility assessments. Subjects who continue to be eligible will be equally randomized to one of the following treatment groups:
- Microdose atropine 0.1% ophthalmic solution
- Microdose atropine 0.01% ophthalmic solution
- Microdose placebo ophthalmic solution
Randomization will be stratified by iris color (e.g., dark and light) and study site. Study enrollment will be limited to a maximum of 50% of subjects who self-identify as East Asian ethnicity. Subjects will use their assigned study medication daily in both eyes and return for efficacy and safety assessments at 1, 6, 12, 18, 24, 30, and 36 months.
At the Month 36 Visit, subjects in the 2 atropine dose arms will be re-randomized to either placebo or 1 of the 2 doses of atropine ophthalmic solution, while subjects originally assigned to placebo will be re-randomized to one of the 2 atropine ophthalmic solution arms. After re-randomization, all subjects will be followed for an additional year with efficacy and safety examinations at Months 42 and 48.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a multi-center, double masked, randomized, placebo-controlled study evaluating the efficacy of microdosed atropine 0.01%, atropine 0.1% and placebo ophthalmic solutions. Subjects will administer their assigned medication daily in both eyes for 36 months, then be re-randomized to the same or an alternative treatment arm and followed for an additional 12 months.
| Arm | Type | Receives |
|---|---|---|
| Atropine 0.1% Ophthalmic Solution | Experimental | Drug: Atropine 0.1% Ophthalmic SolutionAtropine 0.1% ophthalmic solution administered daily in both eyes using a microdose dispenser |
| Atropine 0.01% Ophthalmic Solution | Experimental | Drug: Atropine 0.01% Ophthalmic SolutionAtropine 0.01% ophthalmic solution administered daily in both eyes using a microdose dispenser |
| Placebo Ophthalmic Solution | Placebo comparator | Drug: Placebo Ophthalmic SolutionPlacebo ophthalmic solution administered daily in both eyes using a microdose dispenser |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Refractive error by cycloplegic autorefraction: myopia -1.00 D to -6.00 D in both eyes; astigmatism ≤ 1.50 D in both eyes; anisometropia < 1.50 D.
- Best-corrected distance visual acuity in current correction of 0.2 logMAR or better with interocular difference ≤ 0.1 logMAR.
- Refractive correction for each eye meets the following criteria: myopia within ± 0.50 D of the manifest refraction at the Screening Visit; cylinder power within ± 0.50 D of the manifest refraction at the Screening Visit; when cylinder power is < 1.00 D, axis within ± 15 degrees of the manifest refraction; when cylinder power is ≥ 1.00 D, axis within ± 5 degrees of the manifest refraction.
Key exclusion criteria (20 listed)
- Current or previous myopia treatment with non-study atropine, pirenzepine or other topical anti-muscarinic agent.
- Current use of bifocals, progressive-addition lenses, or multifocal soft contact lenses.
- Use of rigid gas permeable lenses, including orthokeratology lenses within 90 days of Screening.
- Known atropine allergy.
- Abnormality of the cornea, lens, central retina, iris or ciliary body.
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 0.1% Ophthalmic SolutionAtropine 0.1% ophthalmic solution administered with a microdose dispenser | Drug | Atropine 0.1% Ophthalmic Solution |
| Atropine 0.01% Ophthalmic SolutionAtropine 0.01% ophthalmic solution administered with a microdose dispenser | Drug | Atropine 0.01% Ophthalmic Solution |
| Placebo Ophthalmic SolutionPlacebo ophthalmic solution administered with a microdose dispenser | Drug | Placebo Ophthalmic Solution |
Primary outcome
Myopia progression
Time frame: 36 Months
The proportion of primary study eyes showing less than 0.50 D (spherical equivalent) myopia progression compared to baseline measured using cycloplegic autorefraction.
Results and safety
The study was stopped early (reason given: Interim Analysis reviewed by Data Monitoring Committee indicated futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atropine 0.1% Ophthalmic Solution and Atropine 0.01% Ophthalmic Solution in people with Myopia, run by Eyenovia Inc. at 18 sites 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 3 inclusion and 20 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: stopped early, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 stopped early (reason given: Interim Analysis reviewed by Data Monitoring Committee indicated futility). Results are not available in the source record.
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?
Myopia progression (time frame: 36 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 6 Jan 2025.