NCT06742268 Extension Study on Safety and Rebound Effect of SAT-001 for Myopia in Children
| NCT ID | NCT06742268 |
| Status | Recruiting |
| Phase | — |
| Sponsor | S-Alpha Therapeutics, Inc. |
| Condition | Myopia |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-12-16 |
| Primary Completion | 2025-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2024-12-16 with a primary completion date of 2025-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Paik, MD
PRINCIPAL INVESTIGATOR
Gachon University Gil Medical Center
Frequently Asked Questions
Who can join the NCT06742268 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 8 Years, studying Myopia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06742268 currently recruiting?
Yes, NCT06742268 is actively recruiting participants. Contact the research team at sophie@salphadtx.com for enrollment information.
Where is the NCT06742268 trial being conducted?
This trial is being conducted at Seoul, South Korea, Seoul, South Korea, Hwaseong-si, South Korea, Gwangmyeong, South Korea and 1 additional location.
Who is sponsoring the NCT06742268 clinical trial?
NCT06742268 is sponsored by S-Alpha Therapeutics, Inc.. The principal investigator is Paik, MD at Gachon University Gil Medical Center. The trial plans to enroll 40 participants.