TrueTear in Sjogren's Disease Patients

NCT03719885 | Completed Results FDA Device

• 1 other identifier: 830076
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dry Eye Syndromes; Sjogren's Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Clinically Significant Changes in Visual Acuity

  Immediately following the procedure (ie immediately following use of the device)

• Clinically Significant Changes in Slit Lamp Exam

  Immediately following the procedure (ie immediately following use of the device)

• Number of Adverse Events

  Immediately following the procedure (ie immediately following use of the device)

Study Arms (1)

Intervention

EXPERIMENTAL

Device: TrueTear Intranasal Tear Neurostimulator

Interventions

TrueTear Intranasal Tear Neurostimulator DEVICE

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

Intervention

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Allergan: collaborator

Study Sites (1)

Scheie Eye Institute, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Research Coordinator
• Organization: Penn Medicine

jonathan.lilley@pennmedicine.upenn.edu

215-662-9393

Study Officials

• Giacomina Massaro-Giordano, MD

  Scheie Eye Insitute, University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: October 25, 2018
• Study Start: December 1, 2018
• Primary Completion: April 25, 2019
• Study Completion: December 31, 2019
• Last Updated: July 7, 2023
• Results First Posted: August 25, 2020

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)