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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
S-Alpha Therapeutics, Inc.·Phase 3·ClinicalTrials.gov·device·Device trialRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Myopia
Drug/Device/Intervention
SAT-001
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
S-Alpha Therapeutics, Inc.
Location
Incheon, South Korea
Timeline & enrollment
Phase
Phase 3
Start date
Sep 27, 2023
End date
Sep 30, 2025
Enrollment
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
MyopiaDegenerative myopiaAmblyopia ex anopsiaOcular myiasisMyiasis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06344572
Type
Device Trial
About this record

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.