Extension Study on Safety and Rebound Effect of SAT-001 for Myopia in Children

Recruiting now

Conditions studied: Myopia

In brief

The objective of this clinical trial is to collect data on the rebound effect and long-term safety of SAT-001, a Software as a Medical Device (SaMD) under development for the inhibition and treatment of myopia progression in pediatric patients.

Key facts

Study ID

NCT06742268

Run by

S-Alpha Therapeutics, Inc.

People needed

40

Starts

2024-12-16

Expected to finish

2026-07-30

Last updated by the study team

2025-01-09

Who can join

Age: 5 and older, up to 8. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants who have completed the previous clinical trial (SAT001-KP-002), and their legal guardians who agree to participate in this extension study and are willing to provide the signed informed consent after receiving and comprehending the explanation of the description of this clinical trial (subject under 6 can make a mark for agreement after full information and understanding)

You may not qualify if…

• Participants in the study group of the previous clinical trial (SAT001-KP-002) with a compliance rate of less than 70% (overall compliance throughout the study period).
• Other reasons for participation in the trial at the discretion of the investigator

Where it is running

• Kangbuk Samsung Hospital — Seoul, Choose One..., South Korea (enrolling)
• Hallym University Dongtan Sacred heart Hospital — Hwaseong-si, Gyeonggi-do, South Korea (enrolling)
• Gachon University Gil Medical Center — Incheon, South Korea (enrolling)
• Seoul Asan Medical Center — Seoul, Choose One..., South Korea
• Chung-Ang University Gwang Myeong Hospital — Gwangmyeong, South Korea

Full record on ClinicalTrials.gov

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