Boston, Massachusetts 02111


Purpose:

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.


Study summary:

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.


Criteria:

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.


NCT ID:

NCT03674892


Primary Contact:

Principal Investigator
Pedram Hamrah, MD
Tufts Medical Center

Pedram Hamrah, MD
Phone: 617-636-5720
Email: phamrah@tuftsmedicalcenter.org


Backup Contact:

Email: ngee@tuftsmedicalcenter.org
Nancy Gee, MPH
Phone: 617-636-5489


Location Contact:

Boston, Massachusetts 02111
United States

Nancy Gee, MPH
Phone: 617-636-5489
Email: ngee@tuftsmedicalcenter.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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