Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2026-02-26 @ 11:04 AM
Study NCT ID:
NCT02385292
Status:
COMPLETED
Last Update Posted:
2021-10-19
First Post:
2015-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multicenter Trial Evaluating Quality of Tears Produced by Nasal Neurostimulation
Sponsor:
Oculeve, Inc.
Organization:
Study Overview
Official Title:
Randomized, Controlled, Crossover, Multicenter Trial Comparing Quality of Tears Produced by Nasal Neurostimulation Versus Sham for Dry Eye
Status:
COMPLETED
Status Verified Date:
2021-09
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:
The objectives of this study are:
* To compare the change in levels of tear proteins and inflammatory mediators pre and post administration between the intranasal and extranasal applications
* To compare the goblet cell count following application between the intranasal and extranasal applications
* To compare fluorescein tear clearance with the application of the device intranasally and extranasally applications
* To compare the change in levels of tear proteins and inflammatory mediators pre and post administration between the intranasal and extranasal applications
* To compare the goblet cell count following application between the intranasal and extranasal applications
* To compare fluorescein tear clearance with the application of the device intranasally and extranasally applications
Detailed Description:
In this study, subjects will participate for three study days during up to a 44 day period, consisting of a screening examination to determine eligibility on one day and study applications on two different days. There are two applications, intranasal and extranasal. Subjects will receive both applications, in random sequence, one at each of the two application days (Visit 2 and Visit 3). The two applications consist of:
* Active intranasal device application
* Active extranasal device application
* Active intranasal device application
* Active extranasal device application
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: