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

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-design, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of CTO0308 in Pediatric Patients With Myopia

This study was to evaluate the superiority of the myopia progression control effect in the treatment group compared with the control group, evaluated by the change in spherical equivalent (SE) after 12 months of administration of the investigational product.

Inclusion Criteria:

1. Children aged ≥5 years and ≤12 years at the time of informed consent.

2. 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, with an inter-eye difference in SE of ≤2.00 D.
   • Astigmatism of ≤2.50 D.

3. Participants with myopia progression of ≥0.50 D in both eyes within the past year, as confirmed by medical history, refractive examination findings, or changes in spectacle lens prescription at Visit 1.

4. Participants with distance-corrected visual acuity of 0.2 (logMAR) or better in both eyes at screening.

5. Participants with intraocular pressure of ≤21 mmHg in each eye at screening.

6. 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:

1. Participants who have undergone vision correction surgery or procedures.

2. Participants with ocular surgery within 6 months before screening or planned ocular surgery during the study.

3. Participants with glaucoma, narrow-angle, shallow anterior chamber, or other risk factors for elevated intraocular pressure.

4. Participants with macular degeneration, congenital retinal disease, cataract, or other optic nerve disease affecting vision.

5. Participants with amblyopia or strabismus, except intermittent exotropia.

6. Participants with impaired binocular or stereoscopic vision.

7. Participants with chronic or recurrent inflammatory ocular disease or active ocular infection.

8. Participants with prior use of atropine eye drops for myopia control before screening.

9. 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.

10. Participants with corneal abnormalities that may interfere with visual acuity assessment, including corneal opacity, scarring, dystrophy, or dysplasia.

11. Participants who require or are expected to require contact lens use during the study.

12. Participants with a history of hypersensitivity to any component of the investigational product.

13. Participants with diseases requiring caution with any component of the investigational product, including:

    • Down syndrome
    • Brain injury
    • Spastic paralysis
    • Prostatic hypertrophy
    • Voiding dysfunction due to bladder weakness, megacolon, or acute pulmonary edema
    • History of sensitivity to belladonna alkaloids

14. Participants with Marfan syndrome, Stickler syndrome, retinopathy of prematurity, Ehlers-Danlos syndrome, or progressive retinal atrophy that may cause severe myopia.

15. Participants who have undergone organ or bone marrow transplantation.

16. Participants with brain disease that may affect visual acuity.

17. Participants with clinically significant cardiovascular or respiratory disease or spastic paralysis due to brain injury, including cerebral palsy.

18. Participants who were born prematurely or with low birth weight, unless currently above the normal range according to growth charts.

19. Participants who received another investigational drug within 30 days before study participation.

20. 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.