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

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ClinicalTrials.gov Identifier: NCT03942419
Recruitment Status : Recruiting
First Posted : May 8, 2019
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Eyenovia Inc.

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 Intervention/treatment Phase
Myopia Drug: Atropine 0.1% Ophthalmic Solution Drug: Atropine 0.01% Ophthalmic Solution Drug: Placebo Ophthalmic Solution 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.


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Study Type : Interventional  (Clinical Trial)
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)
Masking Description: There will be no differences in the presentation of study drug administered. All study personnel conducting ophthalmic assessments will be masked to treatment assignment.
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 3, 2019
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine


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




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.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years 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 cycloplegic refraction at the Screening Visit; cylinder power within ± 0.50 D of the cycloplegic refraction at the Screening Visit; when cylinder power is < 1.00 D, axis within ± 15 degrees of the cycloplegic refraction; when cylinder power is ≥ 1.00 D, axis within ± 5 degrees of the cycloplegic 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03942419


Contacts
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Contact: Greg M Bennett, MSEd 650-504-2005 gbennett@eyenoviabio.com
Contact: Ginger Clasby, MS 714-269-8838 gclasby@eyenoviabio.com

Locations
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United States, Arizona
Midwestern University Recruiting
Glendale, Arizona, United States, 85308
Contact: Tracy Bland    623-806-7246    tbland@midwestern.edu   
United States, California
Marshall Ketchum University College of Optometry Recruiting
Los Angeles, California, United States, 90037
Contact: Susan Parker       sparker@ketchum.edu   
United States, Georgia
Dixon Eye Care Recruiting
Albany, Georgia, United States, 31701
Contact: Shawn Wynn    229-439-7700 ext 2    shawn31721@yahoo.com   
United States, New York
SUNY College of Optometry Recruiting
New York, New York, United States, 10036
Contact: Marc Bicomong       mbicomong@sunyopt.edu   
United States, Pennsylvania
Salus University - The Eye Institute Recruiting
Philadelphia, Pennsylvania, United States, 19141
Contact: Jasmine Campbell    215-276-6021    jcampbell@salus.edu   
United States, Tennessee
Primary Eyecare Group Recruiting
Brentwood, Tennessee, United States, 37027
Contact: Christina Emerton    615-373-0080    cemerton@primaryeyecare.com   
Sponsors and Collaborators
Eyenovia Inc.
Investigators
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Study Director: Tsontcho Ianchulev, MD, MPH Eyenovia Inc.

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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: August 30, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases
Atropine
Ophthalmic Solutions
Pharmaceutical Solutions
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action