Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

TrueTear in Sjogren's Disease Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03719885
Recruitment Status : Completed
First Posted : October 25, 2018
Results First Posted : August 25, 2020
Last Update Posted : August 25, 2020
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Sjogren's Syndrome Device: TrueTear Intranasal Tear Neurostimulator Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Controlled Study of Intranasal Tear Neurostimulation for Sjogrens Patients With Dry Eye Disease
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : July 25, 2019
Actual Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03719885


Locations
Layout table for location information
United States, Pennsylvania
Scheie Eye Institute, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Allergan
Investigators
Layout table for investigator information
Principal Investigator: Giacomina Massaro-Giordano, MD Scheie Eye Insitute, University of Pennsylvania
  Study Documents (Full-Text)

Documents provided by University of Pennsylvania:
Study Protocol and Statistical Analysis Plan  [PDF] September 10, 2019
Informed Consent Form  [PDF] November 19, 2018

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03719885    
Other Study ID Numbers: 830076
First Posted: October 25, 2018    Key Record Dates
Results First Posted: August 25, 2020
Last Update Posted: August 25, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Sjogren's Syndrome
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Syndrome
Disease
Pathologic Processes
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
 Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases