TrueTear in Sjogren's Disease Patients

Prospective Controlled Study of Intranasal Tear Neurostimulation for Sjogrens Patients With Dry Eye Disease

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes; Sjogren's Syndrome
• Intervention / Treatment: Device: TrueTear Intranasal Tear Neurostimulator

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Scheie Eye Institute, University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Schirmer Testing	Tear production measured immediately following intranasal tear neurostimulation. For this measurement, Schirmer strips (small strips of paper with measurements on them) are placed in the corner of each eye. The amount of wetting of the Schirmer strips is measured in millimeters. Wetting of less than 5 mm is indicative of deficient tear production.	Immediately following the procedure (ie immediately following use of the device)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinically Significant Changes in Visual Acuity	Clinically significant change in Best corrected visual acuity (BCVA)- this measurement was taken to determine if a significant change in BCVA was noted for participants. If a clinically significant change was noted (greater or equal to 2 lines of vision) then a subject would be listed in the data table below.	Immediately following the procedure (ie immediately following use of the device)
Clinically Significant Changes in Slit Lamp Exam	Clinically significant changes in slit lamp examination . Subjects who experienced clinically significant changes would be represented in the data table below.	Immediately following the procedure (ie immediately following use of the device)
Number of Adverse Events	Pain, headache, nosebleed, etc felt to be associated with use of the device	Immediately following the procedure (ie immediately following use of the device)

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Allergan
• Investigators: Principal Investigator: Giacomina Massaro-Giordano, MD, Scheie Eye Insitute, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): April 25, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: October 19, 2018
• First Submitted That Met QC Criteria: October 23, 2018
• First Posted (Actual): October 25, 2018

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 5, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Sjogren's Syndrome
• Other Study ID Numbers: 830076

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No