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

NCT07790640 | Active Not Recruiting Phase 3

• 1 other identifier: CTO0308
• Study Type: interventional
• Target: 351
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Change in Spherical Equivalent (SE) The change from baseline in spherical equivalent (SE) at 12 months after administration, to evaluate the superiority of the myopia progression control effect of the treatment groups compared with the control group.

  Month 12

Secondary Outcomes (3)

• Change in Axial Length The change from baseline in axial length after administration of the investigational product.

  Months 4, 8 and 12

• Change in Spherical Equivalent (SE) The change from baseline in spherical equivalent (SE) after administration of the investigational product.

  Months 4 and 8

• Proportion of Participants With Myopia Progression of Less Than 0.5 D The proportion of participants with myopia progression of less than 0.5 D from baseline after administration of the investigational product.

  Month 12

Study Arms (4)

CTO0308-A

EXPERIMENTAL

Ophthalmic solution

Drug: CTO0308

CTO0308-B

EXPERIMENTAL

Ophthalmic solution

Drug: CTO0308

CTO0308-C

EXPERIMENTAL

Ophthalmic solution

Drug: CTO0308

CTO0308-D

PLACEBO COMPARATOR

Vehicle

Drug: Vehicle (Placebo solution)

Interventions

CTO0308 DRUG

Ophthalmic solution, one drop in each eye, once daily

CTO0308-A; CTO0308-B; CTO0308-C

Vehicle (Placebo solution) DRUG

Vehicle, one drop in each eye, once daily

CTO0308-D

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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, with an inter-eye difference in SE of ≤2.00 D.
• Astigmatism of ≤2.50 D.
• 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.
• Participants with distance-corrected visual acuity of 0.2 (logMAR) or better in both eyes at screening.
• Participants with intraocular pressure of ≤21 mmHg in each eye 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).

You may not qualify if:

• 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 glaucoma, narrow-angle, shallow anterior chamber, or other risk factors for elevated intraocular pressure.
• Participants with macular degeneration, congenital retinal disease, cataract, or other optic nerve disease affecting vision.
• Participants with amblyopia or strabismus, except intermittent exotropia.
• 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
• Brain injury

Sponsors & Collaborators

• Taejoon Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Gachon University Gil Medical Center

Incheon, Incheon, South Korea

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start: August 11, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)