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TrueTear in Sjogren's Disease Patients

Primary Purpose

Dry Eye Syndromes, Sjogren's Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TrueTear Intranasal Tear Neurostimulator
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Scheie Eye Institute, University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Number of Adverse Events
Pain, headache, nosebleed, etc felt to be associated with use of the device

Full Information

First Posted
October 19, 2018
Last Updated
July 5, 2023
Sponsor
University of Pennsylvania
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT03719885
Brief Title
TrueTear in Sjogren's Disease Patients
Official Title
Prospective Controlled Study of Intranasal Tear Neurostimulation for Sjogrens Patients With Dry Eye Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
April 25, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Allergan

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes, Sjogren's Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
TrueTear Intranasal Tear Neurostimulator
Intervention Description
This study will evaluate the immediate tear production resulting from use of intranasal tear neurostimulation in patients with Sjogren's disease
Primary Outcome Measure Information:
Title
Schirmer Testing
Description
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.
Time Frame
Immediately following the procedure (ie immediately following use of the device)
Secondary Outcome Measure Information:
Title
Clinically Significant Changes in Visual Acuity
Description
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.
Time Frame
Immediately following the procedure (ie immediately following use of the device)
Title
Clinically Significant Changes in Slit Lamp Exam
Description
Clinically significant changes in slit lamp examination . Subjects who experienced clinically significant changes would be represented in the data table below.
Time Frame
Immediately following the procedure (ie immediately following use of the device)
Title
Number of Adverse Events
Description
Pain, headache, nosebleed, etc felt to be associated with use of the device
Time Frame
Immediately following the procedure (ie immediately following use of the device)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giacomina Massaro-Giordano, MD
Organizational Affiliation
Scheie Eye Insitute, University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scheie Eye Institute, University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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TrueTear in Sjogren's Disease Patients

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