Clinical trial NCT03719885: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndromes
Sjogren's Syndrome
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2018-10-25
Enrollment: 55
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Schirmer Testing
timeFrame: Immediately following the procedure (ie immediately following use of the device)
Secondary outcomes:
measure: Clinically Significant Changes in Visual Acuity
timeFrame: Immediately following the procedure (ie immediately following use of the device)
measure: Clinically Significant Changes in Slit Lamp Exam
timeFrame: Immediately following the procedure (ie immediately following use of the device)
measure: Number of Adverse Events
timeFrame: Immediately following the procedure (ie immediately following use of the device)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Scheie Eye Institute, University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Scheie Eye Insitute, University of Pennsylvania
name: Giacomina Massaro-Giordano, MD
role: PRINCIPAL_INVESTIGATOR
References: