Randomized double-blind controlled trial of soft contact lenses EDOF150 in Japanese children with myopia

INTERVENTION: Randomly assigned to test group or control group, subjects will wear either contact lenses lens according to the randomization for two years. After two years all subjects will wear control lenses for a year. CONDITION: Mild and moderate myopia and myopic astigmatism PRIMARY OUTCOME: Change of the cycloplegic refractive (spherical equivalent) and axial length at week 104th compared to pre‐examination (baseline). SECONDARY OUTCOME: Change of the cycloplegic refractive (spherical equivalent) and axial length at week 26th, 52th and 78th compared to pre‐examination (baseline). INCLUSION CRITERIA: 1) Children aged 6 to 12 at the time of consent acquisition. 2) Children with cycloplegic objective refractive error (spherical equivalent) in both eyes from ‐0.75 to ‐6.00D. 3) Children with cycloplegic astigmatism no more than 1.00D. 4) Children with cycloplegic spherical equivalent difference of 1.50D or less between the left and right eyes. 5) Children with best corrected visual acuity of 1.0 or higher in each eye. 6) Children who can undergo cycloplegia. 7) Children who can attend all scheduled visits according to the clinical trial plan. 8) Children who along with their legal guardians (parents) have been signed the informed consent form to participate in this clinical trial.