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

NCT03942419 | Terminated Phase 3 FDA Drug

• 1 other identifier: EYN-MYO-AT-31
• Study Type: interventional
• Target: 438
• Locations: 1 country
• Sites: 18

Brief 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.

Conditions

Myopia

Outcome Measures

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.

  36 Months

Study Arms (3)

Atropine 0.1% Ophthalmic Solution

EXPERIMENTAL

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

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

Drug: Atropine 0.01% Ophthalmic Solution

Placebo Ophthalmic Solution

PLACEBO COMPARATOR

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

Drug: Placebo Ophthalmic Solution

Interventions

Atropine 0.1% Ophthalmic Solution DRUG

Atropine 0.1% ophthalmic solution administered with a microdose dispenser

Atropine 0.1% Ophthalmic Solution

Atropine 0.01% Ophthalmic Solution DRUG

Atropine 0.01% ophthalmic solution administered with a microdose dispenser

Atropine 0.01% Ophthalmic Solution

Placebo Ophthalmic Solution DRUG

Placebo ophthalmic solution administered with a microdose dispenser

Placebo Ophthalmic Solution

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eyenovia Inc.: lead

Study Sites (18)

University of Alabama at Birmingham School of Optometry

Birmingham, Alabama, 35294, United States

Location

Midwestern University

Glendale, Arizona, 85308, United States

Location

Canyon City Eyecare

Azusa, California, 91702, United States

Location

UC Berkeley

Berkeley, California, 94720, United States

Location

Marshall Ketchum University College of Optometry

Los Angeles, California, 90037, United States

Location

Ratner Children's Eye Center

San Diego, California, 92093, United States

Location

Illinois College of Optometry

Chicago, Illinois, 60616, United States

Location

Midwestern University

Downers Grove, Illinois, 60515, United States

Location

SUNY College of Optometry

New York, New York, 10036, United States

Location

Wake Forest Health Network Ophthalmology - Oak Hollow

High Point, North Carolina, 27262, United States

Location

Oculus Research

Raleigh, North Carolina, 27603, United States

Location

The Ohio State University - College of Optometry

Columbus, Ohio, 43210, United States

Location

Scott & Christie and Associates

Cranberry Township, Pennsylvania, 16066, United States

Location

Salus University - The Eye Institute

Philadelphia, Pennsylvania, 19141, United States

Location

Primary Eyecare Group

Brentwood, Tennessee, 37027, United States

Location

Southern College of Optometry

Memphis, Tennessee, 38104, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Virginia Pediatric Eye Center

Virginia Beach, Virginia, 23452, United States

Location

MeSH Terms

Conditions

Myopia

Interventions

Atropine; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: There will be no differences in the presentation of study drug administered. All study personnel conducting ophthalmic assessments will be masked to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 8, 2019
• Study Start: June 3, 2019
• Primary Completion: October 31, 2024
• Study Completion: November 20, 2024
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)