Myopia, or nearsightedness, is the most common eye disorder, often affecting more than 40% of adults in Europe, Asia and the USA. Severe myopia is associated with an increased risk of developing other eye conditions such as glucoma, cataracts and retinal detachment, which may lead to blindness. Early treatment of myopia in children could help slow the condition and minimize the risk of complications later in life. This study investigates the use of SYD-101, an eye solution, in slowing-down the progression of myopia in children.
This will be a 3-arm, multicentered, randomized, double-masked, vehicle-controlled study conducted in 2 parts. Part 1 is the primary treatment period of 3 years, during which participants will receive 1 of 3 masked medications. Part 2 is the randomized withdrawal period of 1 year, during which participants originally receiving Vehicle will receive SYD-101, and participants originally receiving SYD-101 will receive either Vehicle or SYD-101.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
852
Sterile topical ophthalmic solution
Sterile topical ophthalmic solution
Sterile topical ophthalmic solution without active ingredient
Myopic progression >0.75 D (diopters)
Proportion of participants with confirmed myopic progression \>0.75 D (diopters), based on SE (spherical equivalent) as measured by cycloplegic autorefraction
Time frame: Month 36
Mean annual myopic progression
Mean annual progression rate of myopia measured in diopters: Spherical Equivalent (SE) as measured by cycloplegic autorefraction.
Time frame: Month 36
Proportion of participants with annual myopia progression rate <=0.50 D/year
Mean annual progression rate of myopia
Time frame: Through Month 36
Proportion of participants with annual myopia progression rate <=0.25 D/year
Mean annual progression rate of myopia
Time frame: Through Month 36
Proportion of participants with annual myopia progression rate > 0.50 D/year
Mean annual progression rate of myopia
Time frame: Month 36
Time to progression of myopia >0.75 D (diopters)
Progression of myopia measured as Spherical Equivalent (SE) via cycloplegic autorefraction.
Time frame: Up to 36 months (from date of randomization until date myopia progresses >0.75 D)
Mean change from baseline in axial length (subset only)
Measured by cycloplegic biometry
Time frame: Baseline to Month 36
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