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RECRUITING
NCT06344572
NA

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

Sponsor: S-Alpha Therapeutics, Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

5 Years - 8 Years

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2023-09-27

Completion Date

2025-09-30

Last Updated

2025-08-13

Healthy Volunteers

No

Conditions

Interventions

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

Locations (1)

Gachon University Gil Hospital

Incheon, South Korea