Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:27 AM
Study NCT ID:
NCT06034327
Status:
RECRUITING
Last Update Posted:
2024-12-20
First Post:
2023-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens
Sponsor:
SightGlass Vision, Inc.
Organization:
Study Overview
Official Title:
Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens
Status:
RECRUITING
Status Verified Date:
2024-12
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:
EUCALYPTUS
Brief Summary:
This is a conventional efficacy trial to validate the results from previous clinical trials for younger children; the 12-month efficacy results will be used to predict the 3-year treatment efficacy.
This is a randomized, controlled (1:1), multisite, subject- and observer-masked, 2-arm parallel group study.
This is a randomized, controlled (1:1), multisite, subject- and observer-masked, 2-arm parallel group study.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: