Intranasal Neurostimulation in Ameliorating Symptoms of Neuropathic Corneal Pain

NCT03674892 | Terminated Results FDA Device

• 1 other identifier: 12978
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Cornea

Keywords

Intranasal Neurostimulation

Outcome Measures

Primary Outcomes (1)

• Change to Overall Pain by the Visual Analogue Scale (VAS) After Intranasal Neurostimulator (ITN) Stimulation at Baseline

  The Visual Analogue Scale (VAS) is a 10 cm line, with one end labeled 'no pain' (which is equivalent to a score of 0 on the numerical scale) and the other end labeled 'worst pain imaginable' (which is equivalent to a score of 10 on the numerical scale). The patient is asked to mark the scale according to the intensity of their eye pain, and the examiner measures the distance in centimeters from the 'no pain' end of the line to score the VAS. The level of discomfort/pain before and after ITN was assessed using the VAS questionnaire (0-10). The changes in overall eye pain after ITN were recorded. Higher scores on the VAS indicate more intense pain and a worse outcome.

  immediately before and after ITN on Day 1 (baseline)

Secondary Outcomes (12)

• Change to Overall Pain by the Visual Analogue Scale (VAS) After Daily Intranasal Neurostimulator (ITN) Stimulation Over 45-day Period

  immediately before and after ITN on Day 45

• Change to Overall Pain by the Visual Analogue Scale (VAS) After Daily Intranasal Neurostimulator (ITN) Stimulation Over 90-day Period

  immediately before and after ITN on Day 90

• Quality of Life as Measured With OPAS at Baseline

  Day 1 (Baseline)

• Quality of Life as Measured Daily With OPAS at 45 Days

  45 days

• Quality of Life as Measured Daily With OPAS at 90 Days

  90 days

Study Arms (1)

TrueTear™ intranasal neurostimulator (ITN)

EXPERIMENTAL

TrueTear™ intranasal neurostimulator (ITN)

Device: TrueTear™ intranasal neurostimulator (ITN)

Interventions

TrueTear™ intranasal neurostimulator (ITN) DEVICE

TrueTear™ intranasal neurostimulator (ITN)

TrueTear™ intranasal neurostimulator (ITN)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>22
• Ability to consent to study.
• Symptoms of neuropathic corneal pain for at least 3 months, such as burning, stinging, light sensitivity, discomfort or pain.
• Positive in vivo confocal microscopy (IVCM) findings for NCP such as presence of microneuromas and decreased nerve density.
• Fifty percent or more relief of pain or discomfort after instillation of Proparacaine eye drops as measured by the Visual Analogue Scale (VAS).

You may not qualify if:

• Clinically significant acute ocular surface diseases, such as active infectious keratitis or recent ocular surgery in the past 3 months.
• Chronic or recurrent epistaxis, coagulation disorders.
• Nasal or sinus surgery or significant trauma to the nose.
• Severe nasal airway obstruction or vascularized nasal polyps.
• Cardiac demand pacemaker, implanted defibrillator, or other implanted electronic device in the head or neck.
• Chronic or recurrent nosebleeds
• Bleeding disorder
• Known hypersensitivity (allergy) to the hydrogel material
• Disabling arthritis, neuropathy, or limited motor coordination affecting self-handling of the device.

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Limitations and Caveats

Patients were not compliant in returning to clinic for follow-up visits. This may be because these visits were to occur on the same day as their routine clinical follow-up visits and the patients repeatedly skipped or cancelled their visits.

Results Point of Contact

• Title: Pedram Hamrah, MD
• Organization: Tufts Medical Center

pedram.hamrah@tuftsmedicine.org

617-636-5720

Study Officials

• Pedram Hamrah, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: non-randomized, open-label, single arm pilot trial

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: September 18, 2018
• Study Start: September 28, 2018
• Primary Completion: September 9, 2022
• Study Completion: September 9, 2023
• Last Updated: August 24, 2025
• Results First Posted: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)