Ignite Creation Date:
2024-05-06 @ 7:30 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06037850
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-14
First Post:
2023-08-23
Brief Title:
Clinical Trial of Orthokeratology Lens MCOK-01
Sponsor:
Menicon Co Ltd
Organization:
Menicon Co Ltd
Study Overview
Official Title:
Clinical Trial of Orthokeratology Lens MCOK-01
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
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:
A prospective multicenter randomized controlled clinical trial of orthokeratology lens
Detailed Description:
The test product is the orthokeratology lens and the control product is a commercially available orthokeratology lens The number of enrolled subjects is 390 and clinical observation is performed for 12 months
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?:
False
Is an FDA AA801 Violation?:
None