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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
438
Atropine 0.1% ophthalmic solution administered with a microdose dispenser
Atropine 0.01% ophthalmic solution administered with a microdose dispenser
Placebo ophthalmic solution administered with a microdose dispenser
University of Alabama at Birmingham School of Optometry
Birmingham, Alabama, United States
Midwestern University
Glendale, Arizona, United States
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.
Time frame: 36 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 8 more locations