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NCT06344572
Pivotal Study of SAT-001 in Treatment of Pediatric Patient With Myopia
NA trial testing SAT-001 in Myopia in 110 participants. Currently enrolling.
31 August 2025
Quick facts
| Lead sponsor | S-Alpha Therapeutics, Inc. |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 110 |
| Start date | 27 September 2023 |
| Primary completion | 31 August 2025 |
| Estimated completion | 30 September 2025 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- SAT-001
- Single vision spectacles
Conditions studied
- Myopia — all drugs for Myopia →
Sponsor
S-Alpha Therapeutics, Inc.
Who can join
Adults 5 to 8, any sex, with Myopia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Digital therapeutics approach for young children with myopia using SAT-001 (DAYS): study protocol for a randomized controlled trial.
Paik HJ, Lee BJ, Lim DH, Han SY, et al · · 2025 · PMID 40200346 · DOI 10.1186/s13063-025-08717-w
Verify or expand the search:
- PubMed search for NCT06344572
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of SAT-001
Trials testing the same drug.
- NCT06729723 — Exploratory Study on the Effect of SAT-001 on Choroidal Thickness in Pediatric Myopia Patients · NA · completed
Other recruiting trials for Myopia
Currently open trials in the same condition.
- NCT07284966 — Comfort and Vision With TOTAL30 Multifocal Lenses · recruiting
- NCT07078799 — Wavefront-guided LASIK Surgery Compared to Ray Tracing-Guided LASIK Surgery · NA · recruiting
- NCT07585877 — Effect of Branched-Chain Amino Acid Supplementation on Myopia Progression · NA · active not recruiting
- NCT07354945 — An Evaluation of Myopia Control Lenses on Wearing Experience in Myopic Children · NA · recruiting
- NCT07229365 — Children's Viewing Behavior · NA · recruiting
Other S-Alpha Therapeutics, Inc. trials
Trials by the same sponsor.
- NCT06742268 — Extension Study on Safety and Rebound Effect of SAT-001 for Myopia in Children · recruiting
- NCT06734858 — Pivotal Trial of SAT-014 for Trauma and Stressor-Related Disorder Symptoms · NA · completed
- NCT06729723 — Exploratory Study on the Effect of SAT-001 on Choroidal Thickness in Pediatric Myopia Patients · NA · completed
- NCT06439407 — Clinical Trial to Preliminarily Assess the Safety and Feasibility of SAT-014, a Software for Alleviating Symptoms of Tra · NA · completed
- NCT06476197 — Exploratory Trial of SAT-003 in Cancer Cachexia Patients With Discontinued Chemotherapy · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06344572 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by S-Alpha Therapeutics, Inc.
- Last refreshed: 13 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06344572.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing