TrueTear in Sjogren's Disease Patients

University of Pennsylvania

Status

Completed

Conditions

Sjogren's Syndrome

Dry Eye Syndromes

Treatments

Device: TrueTear Intranasal Tear Neurostimulator

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03719885

830076

Details and patient eligibility

About

The purpose of this study is to evaluate acute tear production produced by the intranasal tear neurostimulator in participants with Sjögrens syndrome and aqueous tear deficiency. Our primary goal is to evaluate whether Sjögrens patients respond to this intervention and whether there is a baseline tear production level below which these patients do not respond.

Enrollment

55 patients

Sex

All

Ages

22+ years old

Volunteers

Accepts Healthy Volunteers

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