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Active Not Recruiting
NCT07790640
Evaluate the Efficacy and Safety of CTO0308 in Pediatric Patients With Myopia
Conditions: Myopia
Sex: All
Ages: 5 Years – 12 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 351
Sponsor: Taejoon Pharmaceutical Co., Ltd.
Location: Gachon University Gil Medical Center Incheon Incheon
Summary
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.
Eligibility Criteria
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
3. Participants with myopia progression of ≥0.50 D in both eyes within the past year.
4. Participants with distance-corrected visual acuity of 0.2 (logMAR) or better in both eyes at screening.
5. 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 macular degeneration, congenital retinal disease, cataract, or other optic nerve disease affecting vision.
4. Participants with impaired binocular or stereoscopic vision.
5. Participants with chronic or recurrent inflammatory ocular disease or active ocular infection.
6. Participants with prior use of atropine eye drops for myopia control before screening.
7. 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.
8. Participants with corneal abnormalities that may interfere with visual acuity assessment, including corneal opacity, scarring, dystrophy, or dysplasia.
9. Participants who require or are expected to require contact lens use during the study.
10. Participants with a history of hypersensitivity to any component of the investigational product.
11. 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
12. Participants with Marfan syndrome, Stickler syndrome, retinopathy of prematurity, Ehlers-Danlos syndrome, or progressive retinal atrophy that may cause severe myopia.
13. Participants who have undergone organ or bone marrow transplantation.
14. Participants with brain disease that may affect visual acuity.
15. Participants with clinically significant cardiovascular or respiratory disease or spastic paralysis due to brain injury, including cerebral palsy.
16. Participants who were born prematurely or with low birth weight, unless currently above the normal range according to growth charts.
17. Participants who received another investigational drug within 30 days before study participation.
18. 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.
Source: ClinicalTrials.gov (NCT07790640). StuddyBuddy aggregates publicly available trial information.