NCT03674892

Intranasal Neurostimulation in Ameliorating Symptoms of Neuropathic Corneal Pain

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Tufts Medical Center · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cornea

Interventions

Type	Name	Description
DEVICE	TrueTear™ intranasal neurostimulator (ITN)	TrueTear™ intranasal neurostimulator (ITN)

Timeline

• Start date: 2018-09-28
• Primary completion: 2022-09-09
• Completion: 2023-09-09
• First posted: 2018-09-18
• Last updated: 2025-08-24
• Results posted: 2025-08-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study