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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).

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Phase
Phase 3
Study type
Interventional
Enrollment
351
Allocation
Randomized
Ages
5 Years to 12 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 19 studies in Myopia with a site in Korea, Republic of — 2 open to participants now, 4 under way, 1 of them phase 3. Myopia · Korea, Republic of.

Enrollment
2nd of 13
351 · median 70
Started
2025
the only one that year
Phase 3
3 of 19
none open now
Registered
19th of 19
by date
Lead sponsor
1 of 19
Taejoon Pharmaceutical Co., Ltd.

Among the 19 studies in Myopia with a site in Korea, Republic of, this one is the 2nd largest by enrollment of the 13 interventional ones that give a count, is the only one that started in 2025, is one of 3 in phase 3, and was the 19th registered.

Myopia

1,160 studies on the registry are indexed under Myopia; 225 are open to participants now.

Browse Myopia studies →

Open to participants now

2 of the 19 studies in Myopia with a site in Korea, Republic of are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →

Who these studies take

Of the 122 Myopia studies recruiting now, 19 (16%) set no upper age limit and 102 (84%) stop at 75 or younger; 86 take children under 18; 53 take healthy volunteers.

This study: 5 Years to 12 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 19 studies in Myopia with a site in Korea, Republic of, or all of them as a file.
02

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.

03

Conditions studied

  • Myopia

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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

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2025 (actual). Primary completion is estimated for Apr 2027, 19 months after the start.

Of 25 phase 3 interventional studies under Myopia, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 57. This study's planned 19 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 24, 2026
First posted
Aug 27, 2026
StartActual
Aug 11, 2025
Primary completionEst.
Apr 1, 2027
CompletionEst.
Sep 1, 2027
Last update
Sep 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
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
Lead sponsor
Taejoon Pharmaceutical Co., Ltd.
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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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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