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TrueTear in Sjogren's Disease Patients

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ClinicalTrials.gov Identifier: NCT03719885
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : April 26, 2019
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
University of Pennsylvania

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
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
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Schirmer testing [ Time Frame: Immediately following the procedure (ie immediately following use of the device) ]

    the difference between active and control applications in tear production during active stimulation as measured by Schirmer testing

    the difference between active and control applications in tear production during active stimulation as measured by Schirmer testing

    the difference in tear production following active and control applications of the device as measured by Schirmer testing



Secondary Outcome Measures :
  1. Visual acuity [ Time Frame: Immediately following the procedure (ie immediately following use of the device) ]
    Best corrected visual acuity

  2. Slit Lamp exam [ Time Frame: Immediately following the procedure (ie immediately following use of the device) ]
    Anterior segment slit lamp examination

  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



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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

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


Contacts
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Contact: Erin O'Neil, MD 215-662-8100 erin.o'neil@uphs.upenn.edu

Locations
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United States, Pennsylvania
Scheie Eye Institute, University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Erin O'Neil, MD         
Principal Investigator: Giacomina Massaro-Giordano, MD         
Principal Investigator: Vatinee Bunya, MD         
Sponsors and Collaborators
University of Pennsylvania
Allergan
Investigators
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Principal Investigator: Giacomina Massaro-Giordano, MD Scheie Eye Insitute, University of Pennsylvania

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03719885     History of Changes
Other Study ID Numbers: 830076
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

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