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

Recruiting

• Conditions: Myopia

• Registration Number: NCT06742268
• Lead Sponsor: S-Alpha Therapeutics, Inc.

Brief Summary

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.

Detailed Description

Myopia treatments to date have included both pharmacological and non-pharmacological approaches, with some studies showing effects in reducing myopia progression. However, previous research has also identified a rebound effect, where myopia progresses rapidly after treatment cessation during follow-up. Since myopia progression in children often continues for more than two years, this rebound effect could be a critical factor in determining treatment strategies for pediatric myopia.

This multi-center, open-label, controlled observational study is an extension of a previous confirmatory trial (SAT-001-KP-002) that evaluated SAT-001, a Software as a Medical Device (SaMD) designed to slow myopia progression in pediatric patients. The current study aims to assess the rebound effect and long-term safety of SAT-001 in participants who completed the previous trial, and to collect additional data on rebound myopia and long-term safety outcomes following the completion of the initial trial. A total of 40 participants, aged 5 to less than 9 years, from both the treatment and control groups of the prior study will be followed for 6 months after completing the original trial. Participants from the previous trial who had less than 70% compliance will be excluded from this study. Both groups will continue wearing spectacles, the conventional treatment for myopia, during the extension phase. The primary endpoint is the change in cycloplegic spherical equivalent refractive error (SER) from baseline to 24 weeks, while secondary endpoints include changes in SER at 12 weeks and changes in axial length at 12 and 24 weeks compared to baseline.

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-16
• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-16
• Study First Posted: 2024-12-19
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-09
• Primary Completion: 2025-10-30
• Study Completion: 2026-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in spherical equivalent refractive error	baseline, 24 weeks	change in spherical equivalent refractive error at 24 weeks from baseline

Secondary Outcome Measures

Name	Time	Method
change in spherical equivalent refractive error	Baseline, 12 weeks, 24 weeks	change in spherical equivalent refractive error at 12- and 24-week from baseline
change in axial length	Baseline, 12 weeks, 24 weeks	change in axial length at 12-week and 24-week from baseline

Trial Locations

Locations (5)

Kangbuk Samsung Hospital; 🇰🇷 Seoul, Choose One..., Korea, Republic of

Seoul Asan Medical Center; 🇰🇷 Seoul, Choose One..., Korea, Republic of

Chung-Ang University Gwang Myeong Hospital; 🇰🇷 Gwangmyeong, Korea, Republic of

Gachon University Gil Medical Center; 🇰🇷 Incheon, Korea, Republic of

Hallym University Dongtan Sacred heart Hospital; 🇰🇷 Hwaseong, Gyeonggi, Korea, Republic of