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

Myopia Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03942419
• Other study ID #: EYN-MYO-AT-31
• Status: Recruiting
• Phase: Phase 3
• Start date: June 3, 2019
• Est. completion date: June 2028

Study information

• Verified date: April 2024
• Source: Eyenovia Inc.
• Contact: Greg Bennett, M.S. Ed.
• Phone: 833-393-6684
• Email: gbennett[@]eyenovia.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: June 2028
• Est. primary completion date: June 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Drug:
• Atropine 0.1% Ophthalmic Solution
Atropine 0.1% ophthalmic solution administered with a microdose dispenser
• Atropine 0.01% Ophthalmic Solution
Atropine 0.01% ophthalmic solution administered with a microdose dispenser
• Placebo Ophthalmic Solution
Placebo ophthalmic solution administered with a microdose dispenser

Locations

Country	Name	City	State
United States	Canyon City Eyecare	Azusa	California
United States	UC Berkeley	Berkeley	California
United States	Michigan College of Optometry	Big Rapids	Michigan
United States	University of Alabama at Birmingham School of Optometry	Birmingham	Alabama
United States	Primary Eyecare Group	Brentwood	Tennessee
United States	Illinois College of Optometry	Chicago	Illinois
United States	The Ohio State University - College of Optometry	Columbus	Ohio
United States	Scott & Christie and Associates	Cranberry Township	Pennsylvania
United States	Midwestern University	Downers Grove	Illinois
United States	Midwestern University	Glendale	Arizona
United States	Wake Forest Health Network Ophthalmology - Oak Hollow	High Point	North Carolina
United States	Marshall Ketchum University College of Optometry	Los Angeles	California
United States	Southern College of Optometry	Memphis	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	SUNY College of Optometry	New York	New York
United States	Salus University - The Eye Institute	Philadelphia	Pennsylvania
United States	Oculus Research	Raleigh	North Carolina
United States	Ratner Children's Eye Center	San Diego	California
United States	Virginia Pediatric Eye Center	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Eyenovia Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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