TrueTear in Sjogren's Disease Patients

NCT ID: NCT03719885

Last Updated: 2023-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2019-12-31

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.

Conditions

Dry Eye Syndromes; Sjogren's Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Group Type: EXPERIMENTAL

TrueTear Intranasal Tear Neurostimulator

Intervention Type: DEVICE

This study will evaluate the immediate tear production resulting from use of intranasal tear neurostimulation in patients with Sjogren's disease

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giacomina Massaro-Giordano, MD

Role: PRINCIPAL_INVESTIGATOR

Scheie Eye Insitute, University of Pennsylvania

Locations

Scheie Eye Institute, University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

830076

Identifier Type: -

Identifier Source: org_study_id