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

NCT06742268 | Recruiting

• 1 other identifier: SAT001-KP-003
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 5

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.

Conditions

Myopia

Keywords

Myopia; Rebound effect; SaMD

Outcome Measures

Primary Outcomes (1)

• change in spherical equivalent refractive error

  change in spherical equivalent refractive error at 24 weeks from baseline

  baseline, 24 weeks

Secondary Outcomes (2)

• change in spherical equivalent refractive error

  Baseline, 12 weeks, 24 weeks

• change in axial length

  Baseline, 12 weeks, 24 weeks

Study Arms (2)

Arm 1: Spectacles with Cessation of SAT-001 Use

This group consists of pediatric participants who were previously assigned to receive SAT-001 along with single vision spectacles as part of the SAT-001 confirmatory trial (SAT-001-KP-002). In the extension phase, these participants will continue wearing single vision spectacles, but will no longer receive SAT-001 treatment. The aim is to monitor rebound myopia and long-term safety after the completion of the initial trial, focusing on any changes in refractive error and axial length, as well as any adverse effects associated with the cessation of SAT-001 use.

Other: Single vision spectacles

Arm 2: Continued Spectacles Only

This group consists of pediatric participants who were assigned to the control group during the SAT-001 confirmatory trial and received only single vision spectacles. In the extension phase, they will continue wearing spectacles to assess rebound myopia and long-term safety, without the addition of SAT-001 treatment.

Other: Single vision spectacles

Interventions

Single vision spectacles OTHER

Other interventions for myopia treatment, except for glasses, will not be provided.

Arm 1: Spectacles with Cessation of SAT-001 Use; Arm 2: Continued Spectacles Only

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of children aged 5 to 8 years at the time of their participation in the previous confirmatory trial (SAT-001-KP-002), who are continuing in the extension study. Participants will remain in their original groups (study or control group) with no new randomization.

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

Sponsors & Collaborators

• S-Alpha Therapeutics, Inc.: lead

Study Sites (5)

Kangbuk Samsung Hospital

Seoul, Choose One..., 01757, South Korea

RECRUITING

Seoul Asan Medical Center

Seoul, Choose One..., 05505, South Korea

NOT YET RECRUITING

Hallym University Dongtan Sacred heart Hospital

Hwaseong-si, Gyeonggi-do, South Korea

RECRUITING

Chung-Ang University Gwang Myeong Hospital

Gwangmyeong, 14323, South Korea

NOT YET RECRUITING

Gachon University Gil Medical Center

Incheon, 42724, South Korea

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Paik, MD

  Gachon University Gil Medical Center

  PRINCIPAL INVESTIGATOR

• Lee, MD

  Seoul Asan Medical Center

  PRINCIPAL INVESTIGATOR

• Han, MD

  Kangbuk Samsung Hospital

  PRINCIPAL INVESTIGATOR

• Kim, MD

  HanGil Eye Hospital

  PRINCIPAL INVESTIGATOR

• Kim, MD

  Chung-Ang University Gwang Myeong Hospital

  PRINCIPAL INVESTIGATOR

• Park, MD

  Daegu Fatima Hospital

  PRINCIPAL INVESTIGATOR

• Rhiu, MD

  Hallym University Dongtan Sacred Heart Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jihye Lee, MSc

CONTACT

(+82) 2-3487-3923; sophie@salphadtx.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 19, 2024
• Study Start: December 16, 2024
• Primary Completion: October 30, 2025
• Study Completion (Estimated): July 30, 2026
• Last Updated: January 9, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (5)