Six Month Study to Evaluate the Safety and Effectiveness of the Intranasal Lacrimal Neurostimulator

This is a prospective, single-arm, multicenter, open-label clinical trial in which
participants will use the Oculeve Intranasal Lacrimal Neurostimulator to stimulate tear
production for 180 days. Participants will have a Screening Visit within 60 days prior to the
initial device application. Device application will be initiated at Day 0, at which time
participants will receive training on the proper use of the device. Participants will receive
follow-up visits at Days 7, 30, 90 and 180.

Inclusion Criteria:

- Subjects with moderate to severe dry eye disease

- Literate, able to speak English or Spanish, and able to complete questionnaires
independently

- Willing to sign the informed consent and deemed capable of complying with the
requirements of the study protocol

Exclusion Criteria:

- Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the
opinion of the investigator, may lead to clinically significant increased bleeding

- Nasal or sinus surgery (including history of application of nasal cautery) or
significant trauma

- Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device

- Diagnosis of epilepsy

- Corneal transplant in either or both eyes

- Participation in any clinical trial with a new active substance or a new device within
30 days of the Screening Visit

- Women who are pregnant, planning a pregnancy, or nursing at the Screening Visit