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Active, not recruitingNCT07790640Updated Sep 1, 2026

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

A Phase 3 interventional study of CTO0308 and Vehicle (Placebo solution) in Myopia, sponsored by Taejoon Pharmaceutical Co., Ltd.. Active, not recruiting at 1 site in South Korea. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Taejoon Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Aug 2025, registered Aug 2026).
Phase
Phase 3
Study type
Interventional
Enrollment
351
Allocation
Randomized
Ages
5 Years to 12 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Myopia

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03

In context

Myopia

1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.

This study's enrollment of 351 is above the median of 78 across 923 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Taejoon Pharmaceutical Co., Ltd. is the lead sponsor of 16 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

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 .
  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 to any component of the 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 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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
351 participants (actual)

Study arms

  • Experimental
    CTO0308-A

    Ophthalmic solution

    Drug: CTO0308

  • Experimental
    CTO0308-B

    Ophthalmic solution

    Drug: CTO0308

  • Experimental
    CTO0308-C

    Ophthalmic solution

    Drug: CTO0308

  • Placebo comparator
    CTO0308-D

    Vehicle

    Drug: Vehicle (Placebo solution)

Interventions

  • DrugCTO0308

    Ophthalmic solution, one drop in each eye, once daily

  • DrugVehicle (Placebo solution)

    Vehicle, one drop in each eye, once daily

06

What researchers measure

Primary outcomes

  1. Change in Spherical Equivalent (SE)

    The change in spherical equivalent (SE) at 12 months from baseline

    Time frame: Month 12

Secondary outcomes

  1. Change in Axial Length

    The change in axial length at Months 4, 8 and 12 from baseline.

    Time frame: Months 4, 8 and 12

  2. Change in Spherical Equivalent (SE)

    The change in spherical equivalent (SE) from baseline

    Time frame: Months 4 and 8

  3. 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.

    Time frame: Month 12

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07790640
Responsible party
Sponsor
First posted
Aug 27, 2026
Start date
Aug 11, 2025
Primary completion
Apr 1, 2027 (estimated)
Completion
Sep 1, 2027 (estimated)
Last update
Sep 1, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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