TrueTear in Sjogren's Disease Patients

Inclusion Criteria:

- Subjects with Sjögren's syndrome based on American-European Consensus Group (AECG)
American College of Rheumatology (ACR), or American College of Rheumatology/European
League Against Rheumatism (ACR/EULAR) criteria

- Baseline Schirmer score (with topical anesthesia) of ≤10 mm/5 min and retest value
(during nasal stimulation with cotton swab) of at least 4 mm/5min higher than baseline
value

- Baseline Ocular Surface Disease Index® (OSDI) total score ≥13

- Age greater than or equal to 22 years old

- 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:

- Use of any topical ophthalmic medication, including artificial tears, within 4 hours
of either visit

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

- Use of systemic anticoagulants

- Nasal or sinus surgery including nasal cautery or significant trauma

- Severely deviated septum

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

- Have an active implanted metallic or active implanted electronic device in the head, a
cardiac demand pacemaker, or an implanted defibrillator

- Known hypersensitivity to any of the procedural agents or materials in the study
device that contact the nasal mucosa

- Corneal transplant in either or both eyes

- Participation in any clinical trial within 30 days of the Screening Visit

- A woman who is pregnant, planning a pregnancy, or nursing at the Screening Visit