Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06344572
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-03-27
Brief Title:
Pivotal Study of SAT-001 in Treatment of Pediatric Patient With Myopia
Sponsor:
S-Alpha Therapeutics Inc
Organization:
S-Alpha Therapeutics Inc
Study Overview
Official Title:
A Multicenter Randomized Open-label Controlled Pivotal Study to Evaluate the Efficacy and Safety of Software SAT-001 in Slowing Myopia Progression and Treatment in Pediatric Patients With Myopia
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Myopia is a common refractive error affecting approximately 30 of the global population with even higher prevalence in Asian countries including Korea This study is a confirmatory clinical trial designed to evaluate the efficacy and safety of SAT-001 for slowing the progression of myopia in children based on the results of the exploratory clinical trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None