NCT06344572

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: S-Alpha Therapeutics, Inc. · Industry
• Sex: All
• Age: 5 Years – 8 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	SAT-001	Device: SAT-001(a Software as Medical Device) Using SAT-001 application for 48 weeks and wearing single vision spectacles
OTHER	Single vision spectacles	Wearing single vision spectacles

Timeline

• Start date: 2023-09-27
• Primary completion: 2025-08-31
• Completion: 2025-09-30
• First posted: 2024-04-03
• Last updated: 2025-08-13

Locations

1 site across 1 country: South Korea