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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Myopia
• Intervention / Treatment: Device: SAT-001; Other: Single vision spectacles

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.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: YS Park; Phone Number: +82-2-3487-3922; Email: sat-001p@salphadtx.com

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of
    • Recruiting
    • Gachon University Gil Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAT-001; SAT-001(Software as Medical Device)+single vision spectacles	Device: SAT-001; Device: SAT-001(a Software as Medical Device) Using SAT-001 application for 48 weeks and wearing single vision spectacles
Active Comparator: Single vision spectacles; Wearing single vision spectacles	Other: Single vision spectacles; Wearing single vision spectacles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Axial Length	Baseline, 48weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Change in Axial Length	Baseline, 12weeks, 24weeks, 36weeks
Change in cycloplegic Spherical Equivalent Refractive Error	Baseline, 24weeks, 48weeks

Collaborators and Investigators

• Sponsor: S-Alpha Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2023
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: March 27, 2024
• First Submitted That Met QC Criteria: March 27, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2025
• Last Update Submitted That Met QC Criteria: August 8, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: SAT001-KP-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No