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RecruitingNCT06344572Updated Aug 13, 2025

Pivotal Study of SAT-001 in Treatment of Pediatric Patient With Myopia

An interventional study of SAT-001 and Single vision spectacles in Myopia, sponsored by S-Alpha Therapeutics, Inc.. Recruiting at 1 site in South Korea. Open to participants aged 5 Years to 8 Years. Per ClinicalTrials.gov, last updated 2025-08-13.

Sponsored by S-Alpha Therapeutics, Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Registered 6 months after the study started (first participant enrolled Sep 2023, registered Mar 2024).
  • Started Sep 2023; still recruiting 3 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
5 Years to 8 Years
Sex
All
01

Study summary

The objective of this clinical investigation is to evaluate the efficacy and safety of SAT-001 designed as Software as Medical Device (SaMD) for slowing myopia progression and treatment in pediatric myopia patients.

Read the detailed description

Myopia is a common refractive error affecting approximately 30 % of the global population, with even higher prevalence in Asian countries including Korea. This study is a confirmatory clinical trial designed to evaluate the efficacy and safety of SAT-001 for slowing the progression of myopia in children, based on the results of the exploratory clinical trial.

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Conditions studied

  • Myopia

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In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's planned enrollment of 110 is above the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

S-Alpha Therapeutics, Inc. is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

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

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Who can participate

Ages eligible
5 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Children aged 5 to less than 9
  2. Meet the following refractive criteria by cycloplegic refraction

    1. Spherical equivalent refractive error (SER): -0.75 to less than -6.00 D in each eye
    2. Astigmatism of 1.50 D or less in each eye
    3. Anisometropia of 2.00 D or less
  3. Best corrected visual acuity of 0.2 logMAR or better in each eye at the Screening Visit
  4. Able to successfully accomplish SAT-001, the investigational device (able to follow the written and verbal instruction)
  5. Subjects and their legal guardians who agree to participate in the clinical trial and are willing to provide the signed informed consent after receiving and comprehending the explanation of the description of this clinical trial (subject under 6 can make a mark for agreement after full information and understanding)

Exclusion criteria

Exclusion Criteria:

  1. History of atropine use within 3 days prior to Baseline (Visit 2) (prior treatment of myopia control with low dose atropine within 1 month prior to Baseline)
  2. Current or prior use of multifocal lenses (e.g. progressive addition lenses), orthokeratology (Ortho-K, e.g. Dream lens), or Rigid gas permeable (RGP) within 1month prior to Baseline(Visit 2)
  3. Ocular abnormalities in cornea, lens, central retina, iris, ciliary body, etc., or presence of malignant tumors in the orbital area
  4. History of eye diseases such as manifest strabismus, intermittent strabismus, amblyopia, and nystagmus (excluding strabismus that maintains binocular vision)
  5. History of ocular surgery such as eyelid surgery, strabismus surgery, intraocular surgery, or refractive correction surgery (excluding simple double eyelid surgery)
  6. Down's syndrome or cerebral palsy
  7. Within 6 months prior to the Screening visit (Visit 1), has experience of other clinical trial medications or investigational device
  8. Clinically significant systemic diseases such as congenital heart disease, respiratory disease, endocrine disease, and neurological disease that the investigator may consider inappropriate for participation in the clinical trials
  9. Systemic diseases that could impact both vision and visual field
  10. History of growth hormone treatment within 1 month prior to Baseline (Visit 2)
  11. Other reasons for participation in the trial at the discretion of the investigator
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
110 participants (estimated)

Study arms

  • Experimental
    SAT-001

    SAT-001(Software as Medical Device)+single vision spectacles

    Device: SAT-001

  • Active comparator
    Single vision spectacles

    Wearing single vision spectacles

    Other: Single vision spectacles

Interventions

  • DeviceSAT-001

    Device: SAT-001(a Software as Medical Device) Using SAT-001 application for 48 weeks and wearing single vision spectacles

  • OtherSingle vision spectacles

    Wearing single vision spectacles

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What researchers measure

Primary outcomes

  1. Change in Axial Length

    Time frame: Baseline, 48weeks

Secondary outcomes

  1. Change in Axial Length

    Time frame: Baseline, 12weeks, 24weeks, 36weeks

  2. Change in cycloplegic Spherical Equivalent Refractive Error

    Time frame: Baseline, 24weeks, 48weeks

  3. Change in cycloplegic Spherical Equivalent Refractive Error relative to baseline depending on the myopia severity(mild myopia, moderate myopia)

    Time frame: Baseline, 24 weeks, 48 weeks

  4. Change in axial length relative to baseline depending on the myopia severity(mild myopia, moderate myopia)

    Time frame: Baseline, 12weeks, 24weeks, 36weeks, 48weeks

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Study locations

1 of 1 sites recruiting
  • Gachon University Gil Hospital
    Incheon, South Korea
    Recruiting
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References and documents

Publications

  • Paik HJ, Lee BJ, Lim DH, Han SY, Jung EH, Shin HJ, Kim HK, Kim US, Kim WJ, Choi HY, Park J, Rhiu S, Lee J, Kim M, Kim K. Digital therapeutics approach for young children with myopia using SAT-001 (DAYS): study protocol for a randomized controlled trial. Trials. 2025 Apr 8;26(1):128. doi: 10.1186/s13063-025-08717-w. PubMed 40200346 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06344572
Lead sponsor
S-Alpha Therapeutics, Inc.
Responsible party
Sponsor
First posted
Apr 3, 2024
Start date
Sep 27, 2023
Primary completion
Aug 31, 2025 (estimated)
Completion
Sep 30, 2025 (estimated)
Last update
Aug 13, 2025

Study contacts

YS Park
Contact
sat-001p@salphadtx.com
+82-2-3487-3922

Oversight

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

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