TrueTear in Sjogren's Disease Patients

Dry Eye Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03719885
• Other study ID #: 830076
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: July 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 31, 2019
• Est. primary completion date: April 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Sjogren's Syndrome
• Syndrome

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

Locations

Country	Name	City	State
United States	Scheie Eye Institute, University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Immediately following the procedure (ie immediately following use of the device)
Secondary	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.	Immediately following the procedure (ie immediately following use of the device)
Secondary	Number of Adverse Events	Pain, headache, nosebleed, etc felt to be associated with use of the device	Immediately following the procedure (ie immediately following use of the device)