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

  • Clinicaltrials.gov identifier

    NCT03942419

  • Recruitment Status

    Recruiting

  • First Posted

    May 8, 2019

  • Last update posted

    October 19, 2020

Study Description

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.

  • Condition or Disease:Myopia
  • Intervention/Treatment: Drug: Atropine 0.1% Ophthalmic Solution
    Drug: Atropine 0.01% Ophthalmic Solution
    Drug: Placebo Ophthalmic Solution
  • Phase: Phase 3

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

  • Study Type: Interventional
  • Estimated Enrollment: 420 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • 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)
  • Actual Study Start Date: June 2019
  • Estimated Primary Completion Date: June 2024
  • Estimated Study Completion Date: June 2025

Arms and interventions

Arm Intervention/treatment
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
Atropine 0.1% ophthalmic solution administered with a microdose dispenser
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
Atropine 0.01% ophthalmic solution administered with a microdose dispenser
Placebo Comparator: Placebo Ophthalmic Solution
Placebo ophthalmic solution administered daily in both eyes using a microdose dispenser
Drug: Placebo Ophthalmic Solution
Placebo ophthalmic solution administered with a microdose dispenser

Outcome Measures

  • Primary Outcome Measures: 1. 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.

Eligibility Criteria

  • Ages Eligible for Study: 3 to 12 Years (Child)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

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 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.

Contacts and Locations

Contacts

Contact: Kristi Patterson, RN, BSN 561-568-1610 kpatterson@eyenoviabio.com

Contact: Greg M Bennett, MSEd 650-504-2005 gbennett@eyenoviabio.com

Locations

United States, Alabama
University of Alabama at Birmingham School of Optometry
Birmingham

United States, Arizona
Midwestern University
Glendale

United States, California
Canyon City Eyecare
Azusa

United States, California
UC Berkeley
Berkeley

United States, California
Marshall Ketchum University College of Optometry
Los Angeles

United States, California
Ratner Children's Eye Center
San Diego

United States, Illinois
Illinois College of Optometry
Chicago

United States, Illinois
Midwestern University
Downers Grove

United States, Michigan
Michigan College of Optometry
Big Rapids

United States, New York
SUNY College of Optometry
New York

United States, North Carolina
Wake Forest Health Network Ophthalmology - Oak Hollow
High Point

United States, North Carolina
Oculus Research
Raleigh

United States, Ohio
The Ohio State University - College of Optometry
Columbus

United States, Pennsylvania
Scott & Christie and Associates
Cranberry Township

United States, Pennsylvania
Salus University - The Eye Institute
Philadelphia

United States, Tennessee
Primary Eyecare Group
Brentwood

United States, Tennessee
Southern College of Optometry
Memphis

United States, Tennessee
Vanderbilt University Medical Center
Nashville

United States, Virginia
Virginia Pediatric Eye Center
Virginia Beach

Sponsors and Collaborators

Eyenovia Inc.

Investigators

Study Director: Tsontcho Ianchulev, MD, MPH Eyenovia Inc.

More Information

  • Responsible Party: Eyenovia Inc.
  • ClinicalTrials.gov Identifier: NCT03942419 History of Changes
  • Other Study ID Numbers: EYN-MYO-AT-31
  • First Posted: May 8, 2019 Key Record Dates
  • Last Update Posted: October 19, 2020
  • Last Verified: October 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Myopia