Evaluate the Efficacy and Safety of CTO0308 in Pediatric Patients With Myopia

Inclusion criteria

• Children aged ≥5 years and ≤12 years at the time of informed consent.
• Participants who meet all of the following refractive criteria in both eyes at screening and randomization:

• Spherical equivalent (SE) between -1.00 D and -7.00 D
• Participants with myopia progression of ≥0.50 D in both eyes within the past year.
• Participants with distance-corrected visual acuity of 0.2 (logMAR) or better in both eyes at screening.
• Participants whose parent voluntarily provided written informed consent for participation in the clinical trial (or the participant and one of the participant's parents provided written informed consent).

Exclusion criteria

• Participants who have undergone vision correction surgery or procedures.
• Participants with ocular surgery within 6 months before screening or planned ocular surgery during the study.
• Participants with macular degeneration, congenital retinal disease, cataract, or other optic nerve disease affecting vision.
• Participants with impaired binocular or stereoscopic vision.
• Participants with chronic or recurrent inflammatory ocular disease or active ocular infection.
• Participants with prior use of atropine eye drops for myopia control before screening.
• Participants with prior use of myopia control lenses or spectacles, except those who discontinued due to intolerance or lack of efficacy and completed a ≥12-week washout period.
• Participants with corneal abnormalities that may interfere with visual acuity assessment, including corneal opacity, scarring, dystrophy, or dysplasia.
• Participants who require or are expected to require contact lens use during the study.
• Participants with a history of hypersensitivity to any component of the investigational product.
• Participants with diseases requiring caution with any component of the investigational product, including:

• Down syndrome
• Voiding dysfunction due to bladder weakness, megacolon, or acute pulmonary edema
• History of sensitivity to belladonna alkaloids
• Participants with Marfan syndrome, Stickler syndrome, retinopathy of prematurity, Ehlers-Danlos syndrome, or progressive retinal atrophy that may cause severe myopia.
• Participants who have undergone organ or bone marrow transplantation.
• Participants with brain disease that may affect visual acuity.
• Participants with clinically significant cardiovascular or respiratory disease or spastic paralysis due to brain injury, including cerebral palsy.
• Participants who were born prematurely or with low birth weight, unless currently above the normal range according to growth charts.
• Participants who received another investigational drug within 30 days before study participation.
• Participants with any other disease or condition that, in the investigator's judgment, may affect the efficacy or safety assessment or make the participant unsuitable for the study.