Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2026-06-08 @ 7:34 PM
Study NCT ID:
NCT03674892
Status:
TERMINATED
Last Update Posted:
2025-08-24
First Post:
2018-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intranasal Neurostimulation in Ameliorating Symptoms of Neuropathic Corneal Pain
Sponsor:
Tufts Medical Center
Organization:
Study Overview
Official Title:
Assessing the Efficacy of Intranasal Neurostimulation in Ameliorating Symptoms of Neuropathic Corneal Pain
Status:
TERMINATED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Original device is now discontinued; we are changing the study device shortly
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INSTANT
Brief Summary:
This study is a prospective, interventional, open-label, single arm, non-randomized trial treating 30 patients with peripheral or mixed neuropathic corneal pain at their baseline exam and following 45 days and 90 days of daily use with the TrueTear™ ITN device.
Detailed Description:
The investigators hypothesize that the stimulation through the ethmoidal nerve in the nasal cavity may have an inhibitory effect on the primary TG interneurons and block the ocular pain signaling to the brain.
The investigators propose a non-randomized, open-label, single arm pilot trial for treatment of neuropathic corneal pain (NCP) with ITN with the following specific aims:
Specific Aims:
1. To elucidate the efficacy of ITN in ameliorating pain among neuropathic corneal pain patients.
2. To elucidate the safety, efficacy, longevity of ITN in ameliorating pain among neuropathic corneal pain patients during a 90-day period with daily use.
3. To assess quality of life changes by treating neuropathic corneal pain with ITN during a 90-day period with daily use.
The investigators propose a non-randomized, open-label, single arm pilot trial for treatment of neuropathic corneal pain (NCP) with ITN with the following specific aims:
Specific Aims:
1. To elucidate the efficacy of ITN in ameliorating pain among neuropathic corneal pain patients.
2. To elucidate the safety, efficacy, longevity of ITN in ameliorating pain among neuropathic corneal pain patients during a 90-day period with daily use.
3. To assess quality of life changes by treating neuropathic corneal pain with ITN during a 90-day period with daily use.
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?: