NCT03942419

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

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)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 438 (actual)
• Sponsor: Eyenovia Inc. · Industry
• Sex: All
• Age: 3 Years – 12 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Atropine 0.1% Ophthalmic Solution	Atropine 0.1% ophthalmic solution administered with a microdose dispenser
DRUG	Atropine 0.01% Ophthalmic Solution	Atropine 0.01% ophthalmic solution administered with a microdose dispenser
DRUG	Placebo Ophthalmic Solution	Placebo ophthalmic solution administered with a microdose dispenser

Timeline

• Start date: 2019-06-03
• Primary completion: 2024-10-31
• Completion: 2024-11-20
• First posted: 2019-05-08
• Last updated: 2025-01-06

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study