Using SAT-001 to treat myopia in children

A Multicenter, Randomized, Open-label, Controlled Pivotal Study to Evaluate the Efficacy and Safety of Software SAT-001 in Slowing Myopia Progression and Treatment in Pediatric Patients With Myopia

This study is testing if a new software treatment can help slow down worsening eyesight in children aged 5 to under 9 who have myopia.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 5 Years to 8 Years
• Sex: All
• Sponsor: S-Alpha Therapeutics, Inc. (Industry-sponsored)
• Locations: 1 site (Incheon)
• Trial ID: NCT06344572 on ClinicalTrials.gov

What this trial studies

This clinical investigation aims to evaluate the efficacy and safety of SAT-001, a Software as Medical Device (SaMD), in slowing the progression of myopia in pediatric patients. The study is designed as a confirmatory clinical trial following an exploratory trial, focusing on children aged 5 to less than 9 years with specific refractive criteria. Participants will use SAT-001 alongside single vision spectacles to assess its impact on myopia progression. The trial will involve rigorous monitoring and evaluation of visual acuity and refractive error.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 5 to less than 9 years with specific refractive errors and visual acuity requirements.

Not a fit: Patients with a history of atropine use within 3 days prior to the baseline visit may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly slow the progression of myopia in children, potentially reducing the risk of severe vision impairment later in life.

How similar studies have performed: Other studies have shown promise in using digital interventions for myopia management, but the specific approach of SAT-001 is novel.

Eligibility criteria

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:

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

Where this trial is running

Incheon

• Gachon University Gil Hospital — Incheon, South Korea (Recruiting)

Study contacts

• Study coordinator: YS Park

Conditions Myopia