A daily eye drop might slow childhood nearsightedness. a trial puts it to the test.
NCT ID NCT07790640
First seen Aug 27, 2026 · Last updated Sep 02, 2026 · Updated 3 times
Summary
This phase 3 trial tests whether an experimental eye drop called CTO0308 can slow the progression of myopia, or nearsightedness, in children aged 5 to 12. Participants receive either the active drop or a placebo once daily in each eye for 12 months. Researchers measure changes in the eye's refractive error and axial length to see if the treatment slows the worsening of nearsightedness compared to placebo.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CTO0308, an ophthalmic solution given as one drop in each eye once daily
- What this could lead to
- If successful, this could provide a simple daily eye drop to slow myopia progression in children, potentially reducing the need for stronger glasses and lowering the risk of future eye problems.
- What could go wrong
- This is a phase 3 trial, but results are not yet available. The treatment may not prove more effective than a placebo, and long-term safety in children is still being evaluated.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
351 people
The number who actually took part.
- Started
-
Aug 2025
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
5 to 12 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Gachon University Gil Medical Center
Incheon, Incheon, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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