Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-27 @ 3:59 AM
Study NCT ID:
NCT06235450
Status:
RECRUITING
Last Update Posted:
2024-02-01
First Post:
2024-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Usability Study of iTEAR100 For Combined EyeLid Microblepharoexfoliation and Neurostimulation
Sponsor:
Olympic Ophthalmics, Inc.
Organization:
Study Overview
Official Title:
A Usability Study of iTEAR100 For Combined EyeLid Microblepharoexfoliation and Neurostimulation
Status:
RECRUITING
Status Verified Date:
2024-01
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 purpose of this study is to evaluate the usability of the iTEAR100 generation 2 device in combination with its newly developed iLIDS100 disposable cover.
Detailed Description:
This usability study is meant to validate treatment using the iLIDS100 in patients who already use the NuLids Device and iTEAR100. The patients will simply substitute the iLIDS100 cover in combination with the iTEAR100 for the NuLids product and otherwise maintain their same treatment regimen. The planned number of subjects was chosen to provide clinically relevant usability data
Study Oversight
Has Oversight DMC:
False
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?: