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Completed

NCT Number: NCT03719885

TrueTear in Sjogren's Disease Patients

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.

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Key information

Conditions

Dry Eye Syndromes Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Eye Diseases Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Mouth Diseases Musculoskeletal Diseases Rheumatic Diseases Salivary Gland Diseases Sjogren's Syndrome Skin and Connective Tissue Diseases Stomatognathic Diseases Xerostomia

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Scheie Eye Institute, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Schirmer Testing

    Time frame: Immediately following the procedure (ie immediately following use of the device)

    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.

Secondary outcomes

  1. Clinically Significant Changes in Visual Acuity

    Time frame: Immediately following the procedure (ie immediately following use of the device)

    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.

  2. Clinically Significant Changes in Slit Lamp Exam

    Time frame: Immediately following the procedure (ie immediately following use of the device)

    Clinically significant changes in slit lamp examination . Subjects who experienced clinically significant changes would be represented in the data table below.

  3. Number of Adverse Events

    Time frame: Immediately following the procedure (ie immediately following use of the device)

    Pain, headache, nosebleed, etc felt to be associated with use of the device

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Allergan

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 25, 2018
Registry last updated
Jul 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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