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Intranasal Neurostimulation in Ameliorating Symptoms of Neuropathic Corneal Pain — INSTANT  

Cornea Clinical Trial

Official title:
Assessing the Efficacy of Intranasal Neurostimulation in Ameliorating Symptoms of Neuropathic Corneal Pain

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03674892
Study type Interventional
Source Tufts Medical Center
Contact
Status Terminated
Phase N/A
Start date September 28, 2018
Completion date September 9, 2023
View Details
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