TrueTear in Sjogren's Disease Patients

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 22 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03719885
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Pennsylvania
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Giacomina Massaro-Giordano, MD
Principal Investigator Affiliation Scheie Eye Insitute, University of Pennsylvania
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherIndustry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Dry Eye Syndromes, Sjogren's Syndrome
Arms & Interventions

Arms

Experimental: Intervention

Interventions

Device: - TrueTear Intranasal Tear Neurostimulator

This study will evaluate the immediate tear production resulting from use of intranasal tear neurostimulation in patients with Sjogren's disease

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Philadelphia, Pennsylvania

Status

Recruiting

Address

Scheie Eye Institute, University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Site Contact

Erin O'Neil, MD

erin.o'[email protected]

215-662-8100