MyopiaPhase 3NCT07790640
Evaluate the Efficacy and Safety of CTO0308 in Pediatric Patients With Myopia
A Phase 3 study testing CTO0308 in people with Myopia, run by Taejoon Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Myopia
- What is being tested?
- CTO0308
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 351 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Aug 2025to 1 Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
- Participants with myopia progression of ≥0.50 D in both eyes within the past year.
- Participants with distance-corrected visual acuity of 0.2 (logMAR) or better in both eyes 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).
Who cannot join
- 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 macular degeneration, congenital retinal disease, cataract, or other optic nerve disease affecting vision.
- 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.
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- 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
- Voiding dysfunction due to bladder weakness, megacolon, or acute pulmonary edema
- History of sensitivity to belladonna alkaloids
- Participants with Marfan syndrome, Stickler syndrome, retinopathy of prematurity, Ehlers-Danlos syndrome, or progressive retinal atrophy that may cause severe myopia.
- Participants who have undergone organ or bone marrow transplantation.
- Participants with brain disease that may affect visual acuity.
- Participants with clinically significant cardiovascular or respiratory disease or spastic paralysis due to brain injury, including cerebral palsy.
- Participants who were born prematurely or with low birth weight, unless currently above the normal range according to growth charts.
- Participants who received another investigational drug within 30 days before study participation.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-design, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of CTO0308 in Pediatric Patients With Myopia
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
- Being tested
- CTO0308, Vehicle (Placebo solution)
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTO0308Drug
Ophthalmic solution, one drop in each eye, once daily
Vehicle (Placebo solution)Drug
Vehicle, one drop in each eye, once daily
| Study group | Role | What they receive |
|---|---|---|
| CTO0308-A | Experimental | Ophthalmic solution Receives: Drug: CTO0308 |
| CTO0308-B | Experimental | Ophthalmic solution Receives: Drug: CTO0308 |
| CTO0308-C | Experimental | Ophthalmic solution Receives: Drug: CTO0308 |
| CTO0308-D | Placebo comparator | Vehicle Receives: Drug: Vehicle (Placebo solution) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Spherical Equivalent (SE)
The change in spherical equivalent (SE) at 12 months from baseline
Measured: Month 12
Secondary outcomes (3)
Change in Axial Length
The change in axial length at Months 4, 8 and 12 from baseline.
Measured: Months 4, 8 and 12
Change in Spherical Equivalent (SE)
The change in spherical equivalent (SE) from baseline
Measured: 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.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start11 Aug 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taejoon Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790640
- Sponsor's protocol ID
- CTO0308
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-design, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of CTO0308 in Pediatric Patients With Myopia
- ClinicalTrials.gov ID
- NCT07790640
- Acronym / sponsor ID
- CTO0308
- Conditions
- Myopia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Taejoon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CTO0308-A | Experimental | Drug: CTO0308Ophthalmic solution |
| CTO0308-B | Experimental | Drug: CTO0308Ophthalmic solution |
| CTO0308-C | Experimental | Drug: CTO0308Ophthalmic solution |
| CTO0308-D | Placebo comparator | Drug: Vehicle (Placebo solution)Vehicle |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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:
- Participants with myopia progression of ≥0.50 D in both eyes within the past year.
- Participants with distance-corrected visual acuity of 0.2 (logMAR) or better in both eyes 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).
Key exclusion criteria (21 listed)
- 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 macular degeneration, congenital retinal disease, cataract, or other optic nerve disease affecting vision.
- Participants with impaired binocular or stereoscopic vision.
- Participants with chronic or recurrent inflammatory ocular disease or active ocular infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTO0308Ophthalmic solution, one drop in each eye, once daily | Drug | CTO0308-A, CTO0308-B, CTO0308-C |
| Vehicle (Placebo solution)Vehicle, one drop in each eye, once daily | Drug | CTO0308-D |
Primary outcome
Change in Spherical Equivalent (SE)
Time frame: Month 12
The change in spherical equivalent (SE) at 12 months from baseline
3 secondary outcomes
Change in Axial Length
Time frame: Months 4, 8 and 12
Change in Spherical Equivalent (SE)
Time frame: Months 4 and 8
Proportion of Participants With Myopia Progression of less Than 0.5 D
Time frame: Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CTO0308 in people with Myopia, run by Taejoon Pharmaceutical Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Spherical Equivalent (SE) (time frame: Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.