Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-24 @ 7:07 PM
Study NCT ID:
NCT04126057
Status:
COMPLETED
Last Update Posted:
2022-01-25
First Post:
2019-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Myopia Assessment of Two Manufacturing Processes
Sponsor:
SightGlass Vision, Inc.
Organization:
Study Overview
Official Title:
Myopia Assessment of Two Manufacturing Processes for Myopia Management Lenses (MAPLE)
Status:
COMPLETED
Status Verified Date:
2021-12
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:
MAPLE
Brief Summary:
Randomized, controlled, multisite, subject- and observer-masked, contralateral clinical trial of 6-month duration to compare two SightGlass Vision Diffusion Optics Technology (DOT) spectacle lens manufacturing processes in reducing the progression of juvenile myopia.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: