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

NCT06344572 | Recruiting

• 1 other identifier: SAT001-KP-002
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Change in Axial Length

  Baseline, 48weeks

Secondary Outcomes (4)

• Change in Axial Length

  Baseline, 12weeks, 24weeks, 36weeks

• Change in cycloplegic Spherical Equivalent Refractive Error

  Baseline, 24weeks, 48weeks

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

  Baseline, 24 weeks, 48 weeks

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

  Baseline, 12weeks, 24weeks, 36weeks, 48weeks

Study Arms (2)

SAT-001

EXPERIMENTAL

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

Device: SAT-001

Single vision spectacles

ACTIVE COMPARATOR

Wearing single vision spectacles

Other: Single vision spectacles

Interventions

SAT-001 DEVICE

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

SAT-001

Single vision spectacles OTHER

Wearing single vision spectacles

Single vision spectacles

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 5 to less than 9
• Meet the following refractive criteria by cycloplegic refraction
• Spherical equivalent refractive error (SER): -0.75 to less than -6.00 D in each eye
• Astigmatism of 1.50 D or less in each eye
• Anisometropia of 2.00 D or less
• Best corrected visual acuity of 0.2 logMAR or better in each eye at the Screening Visit
• Able to successfully accomplish SAT-001, the investigational device (able to follow the written and verbal instruction)
• 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)

You may not qualify if:

• 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)
• 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)
• Ocular abnormalities in cornea, lens, central retina, iris, ciliary body, etc., or presence of malignant tumors in the orbital area
• History of eye diseases such as manifest strabismus, intermittent strabismus, amblyopia, and nystagmus (excluding strabismus that maintains binocular vision)
• History of ocular surgery such as eyelid surgery, strabismus surgery, intraocular surgery, or refractive correction surgery (excluding simple double eyelid surgery)
• Down's syndrome or cerebral palsy
• Within 6 months prior to the Screening visit (Visit 1), has experience of other clinical trial medications or investigational device
• 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
• Systemic diseases that could impact both vision and visual field
• History of growth hormone treatment within 1 month prior to Baseline (Visit 2)
• Other reasons for participation in the trial at the discretion of the investigator

Sponsors & Collaborators

• S-Alpha Therapeutics, Inc.: lead

Study Sites (1)

Gachon University Gil Hospital

Incheon, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 40200346 DERIVED

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

YS Park

CONTACT

+82-2-3487-3922; sat-001p@salphadtx.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 3, 2024
• Study Start: September 27, 2023
• Primary Completion: August 31, 2025
• Study Completion: September 30, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-01

Locations

KR (1)