Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2026-01-01 @ 9:47 PM
Study NCT ID:
NCT07105332
Status:
TERMINATED
Last Update Posted:
2025-08-05
First Post:
2022-09-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Trial of a Sub-conjunctival Insert
Sponsor:
EyeSense GmbH
Organization:
Study Overview
Official Title:
Investigation of a Sub-Conjunctival Insert
Status:
TERMINATED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
terminated after the concept feasibility was succesfully proved, no safety issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OMI
Brief Summary:
The purpose of this single-centre, open label prospective study is to investigate a novel ocular mini insert (OMI) for detection of blood glucose levels in human subjects. First, the optimal technical parameters for measurement are determined on healthy subjects. Secondly, performance measurements follow investigating relationship between OMI signal and blood glucose in diabetes patients during short sessions with oral glucose tolerace test.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: