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

NCT ID: NCT06344572

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-27
• Study Completion Date: 2025-09-30

Brief 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.

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.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SAT-001

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

Group Type: EXPERIMENTAL

SAT-001

Intervention Type: DEVICE

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

Single vision spectacles

Wearing single vision spectacles

Group Type: ACTIVE_COMPARATOR

Single vision spectacles

Intervention Type: OTHER

Wearing single vision spectacles

Interventions

SAT-001

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

Intervention Type: DEVICE

Single vision spectacles

Wearing single vision spectacles

Intervention Type: OTHER

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

S-Alpha Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gachon University Gil Hospital

Incheon, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

YS Park

Role: CONTACT

sat-001p@salphadtx.com

+82-2-3487-3922

References

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.

Reference Type: DERIVED

PMID: 40200346 (View on PubMed)

Other Identifiers

SAT001-KP-002

Identifier Type: -

Identifier Source: org_study_id