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TerminatedNCT03942419Updated Jan 6, 2025

Microdosed Atropine 0.1% and 0.01% Ophthalmic Solutions for Reduction of Pediatric Myopia Progression

A Phase 3 interventional study of Atropine 0.1% Ophthalmic Solution and Atropine 0.01% Ophthalmic Solution in Myopia, sponsored by Eyenovia Inc.. Terminated at 18 sites in United States. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-01-06.

Sponsored by Eyenovia Inc. · Phase 3, Interventional, and Treatment

Why this study was terminated
Interim Analysis reviewed by Data Monitoring Committee indicated futility

From the registry’s dates

  • Primary completion was Oct 2024, 2 years ago, and no results have been posted to the registry.
Phase
Phase 3
Study type
Interventional
Enrollment
438
Allocation
Randomized
Ages
3 Years to 12 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Myopia

Browse trials for

03

In context

Myopia

1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.

This study's enrollment of 438 is above the median of 78 across 923 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Eyenovia Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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 , 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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
438 participants (actual)

Study arms

  • Experimental
    Atropine 0.1% Ophthalmic Solution

    Atropine 0.1% ophthalmic solution administered daily in both eyes using a microdose dispenser

    Drug: Atropine 0.1% Ophthalmic Solution

  • Experimental
    Atropine 0.01% Ophthalmic Solution

    Atropine 0.01% ophthalmic solution administered daily in both eyes using a microdose dispenser

    Drug: Atropine 0.01% Ophthalmic Solution

  • Placebo comparator
    Placebo Ophthalmic Solution

    Placebo ophthalmic solution administered daily in both eyes using a microdose dispenser

    Drug: Placebo Ophthalmic Solution

Interventions

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 36 Months

07

Study locations

18 sites
  • University of Alabama at Birmingham School of Optometry
    Birmingham, Alabama 35294, United States
  • Midwestern University
    Glendale, Arizona 85308, United States
  • Canyon City Eyecare
    Azusa, California 91702, United States
  • UC Berkeley
    Berkeley, California 94720, United States
  • Marshall Ketchum University College of Optometry
    Los Angeles, California 90037, United States
  • Ratner Children's Eye Center
    San Diego, California 92093, United States
  • Illinois College of Optometry
    Chicago, Illinois 60616, United States
  • Midwestern University
    Downers Grove, Illinois 60515, United States
  • SUNY College of Optometry
    New York, New York 10036, United States
  • Wake Forest Health Network Ophthalmology - Oak Hollow
    High Point, North Carolina 27262, United States
  • Oculus Research
    Raleigh, North Carolina 27603, United States
  • The Ohio State University - College of Optometry
    Columbus, Ohio 43210, United States
  • Scott & Christie and Associates
    Cranberry Township, Pennsylvania 16066, United States
  • Salus University - The Eye Institute
    Philadelphia, Pennsylvania 19141, United States
  • Primary Eyecare Group
    Brentwood, Tennessee 37027, United States
  • Southern College of Optometry
    Memphis, Tennessee 38104, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
  • Virginia Pediatric Eye Center
    Virginia Beach, Virginia 23452, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2019 to primary completion in Oct 2024, 64 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 7, 2019
First posted
May 8, 2019
StartActual
Jun 3, 2019
Primary completionActual
Oct 31, 2024
CompletionActual
Nov 20, 2024
Last update
Jan 6, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03942419
Lead sponsor
Eyenovia Inc.
Responsible party
Sponsor
First posted
May 8, 2019
Start date
Jun 3, 2019
Primary completion
Oct 31, 2024
Completion
Nov 20, 2024
Last update
Jan 6, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Atropine

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