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

Myopia Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06344572
Study type Interventional
Source S-Alpha Therapeutics, Inc.
Contact YS Park
Phone +82-2-3487-3922
Email sat-001p@salphadtx.com
Status Recruiting
Phase Phase 3
Start date September 27, 2023
Completion date September 30, 2025
View Details
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