Intranasal Neurostimulation in Ameliorating Symptoms of Neuropathic Corneal Pain

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.

Inclusion Criteria:

1. Age >22

2. Ability to consent to study.

3. Symptoms of neuropathic corneal pain for at least 3 months, such as burning, stinging,
light sensitivity, discomfort or pain.

4. Positive in vivo confocal microscopy (IVCM) findings for NCP such as presence of
microneuromas and decreased nerve density.

5. Fifty percent or more relief of pain or discomfort after instillation of Proparacaine
eye drops as measured by the Visual Analogue Scale (VAS).

Exclusion Criteria:

1. Clinically significant acute ocular surface diseases, such as active infectious
keratitis or recent ocular surgery in the past 3 months.

2. Chronic or recurrent epistaxis, coagulation disorders.

3. Nasal or sinus surgery or significant trauma to the nose.

4. Severe nasal airway obstruction or vascularized nasal polyps.

5. Cardiac demand pacemaker, implanted defibrillator, or other implanted electronic
device in the head or neck.

6. Chronic or recurrent nosebleeds

7. Bleeding disorder

8. Known hypersensitivity (allergy) to the hydrogel material

9. Disabling arthritis, neuropathy, or limited motor coordination affecting self-handling
of the device.