Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-24 @ 3:30 PM
NCT ID:
NCT03674892
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT03674892
Study Brief:
Protocol Section:
NCT03674892