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

NCT ID: NCT03942419

Last Updated: 2025-01-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 438 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-03
• Study Completion Date: 2024-11-20

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Atropine 0.1% Ophthalmic Solution

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

Group Type: EXPERIMENTAL

Atropine 0.1% Ophthalmic Solution

Intervention Type: DRUG

Atropine 0.1% ophthalmic solution administered with a microdose dispenser

Atropine 0.01% Ophthalmic Solution

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

Group Type: EXPERIMENTAL

Atropine 0.01% Ophthalmic Solution

Intervention Type: DRUG

Atropine 0.01% ophthalmic solution administered with a microdose dispenser

Placebo Ophthalmic Solution

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

Group Type: PLACEBO_COMPARATOR

Placebo Ophthalmic Solution

Intervention Type: DRUG

Placebo ophthalmic solution administered with a microdose dispenser

Interventions

Atropine 0.1% Ophthalmic Solution

Atropine 0.1% ophthalmic solution administered with a microdose dispenser

Intervention Type: DRUG

Atropine 0.01% Ophthalmic Solution

Atropine 0.01% ophthalmic solution administered with a microdose dispenser

Intervention Type: DRUG

Placebo Ophthalmic Solution

Placebo ophthalmic solution administered with a microdose dispenser

Intervention Type: DRUG

Eligibility Criteria

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

• 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 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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eyenovia Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Alabama at Birmingham School of Optometry

Birmingham, Alabama, United States

Midwestern University

Glendale, Arizona, United States

Canyon City Eyecare

Azusa, California, United States

UC Berkeley

Berkeley, California, United States

Marshall Ketchum University College of Optometry

Los Angeles, California, United States

Ratner Children's Eye Center

San Diego, California, United States

Illinois College of Optometry

Chicago, Illinois, United States

Midwestern University

Downers Grove, Illinois, United States

SUNY College of Optometry

New York, New York, United States

Wake Forest Health Network Ophthalmology - Oak Hollow

High Point, North Carolina, United States

Oculus Research

Raleigh, North Carolina, United States

The Ohio State University - College of Optometry

Columbus, Ohio, United States

Scott & Christie and Associates

Cranberry Township, Pennsylvania, United States

Salus University - The Eye Institute

Philadelphia, Pennsylvania, United States

Primary Eyecare Group

Brentwood, Tennessee, United States

Southern College of Optometry

Memphis, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Virginia Pediatric Eye Center

Virginia Beach, Virginia, United States

Countries

United States

Other Identifiers

EYN-MYO-AT-31

Identifier Type: -

Identifier Source: org_study_id