NCT05917041

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

A Randomised, Open-label, Multicenter, Controlled, Exploratory Study on the Effect and Safety of SAT-001 as a Medical Device in Treatment of Pediatric Patients With Myopia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: S-Alpha Therapeutics, Inc. · Industry
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The Purpose of this study is to explore the safety and effectiveness of SAT-001, a medical device for the treatment of myopia in pediatric patient with myopia

Detailed description

Myopic pediatric prevalence rate come to increase rapidly globally. This is a clinical trial to explore the safety and effectiveness of SAT-001(as a Software as Medical Device) developed for the treatment of myopia through suppressing the progress myopia

Conditions

• Children Myopia

Interventions

Type	Name	Description
DEVICE	SAT-001(Software as Medical Device)	Using SAT-001 application for 48 weeks and wearing glasses or not

Timeline

• Start date: 2021-03-05
• Primary completion: 2023-04-19
• Completion: 2024-04-03
• First posted: 2023-06-23
• Last updated: 2024-05-03

Locations

6 sites across 1 country: South Korea