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Pivotal Study of SAT-001 in Treatment of Pediatric Patient With Myopia - Trial NCT06344572

Access comprehensive clinical trial information for NCT06344572 through Pure Global AI's free database. This Phase 3 trial is sponsored by S-Alpha Therapeutics, Inc. and is currently Recruiting. The study focuses on Myopia. Target enrollment is 110 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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NCT06344572
Phase 3
Recruiting
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device
Trial Details
ClinicalTrials.gov โ€ข NCT06344572
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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

Study Focus

Myopia

SAT-001

Interventional

device

Sponsor & Location

S-Alpha Therapeutics, Inc.

Incheon, South Korea

Timeline & Enrollment

Phase 3

Sep 27, 2023

Sep 30, 2025

110 participants

Primary Outcome

Change in Cycloplegic Spherical Equivalent Refractive Error

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.

ICD-10 Classifications

Myopia
Degenerative myopia
Amblyopia ex anopsia
Ocular myiasis
Myiasis

Data Source

ClinicalTrials.gov

NCT06344572

Device Trial