Dry Eye SyndromesNCT03719885

TrueTear in Sjogren's Disease Patients

A study testing TrueTear Intranasal Tear Neurostimulator in people with Dry Eye Syndromes and Sjogren's Syndrome, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 22 years and olderHealthy volunteers can take part
Conditions the study is for: Dry Eye Syndromes, Sjogren's Syndrome
What is being tested?: TrueTear Intranasal Tear Neurostimulator
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 1 siteUnited States
Study dates: 1 Dec 2018to 31 Dec 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Scheie Eye Institute, University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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

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
Being tested: TrueTear Intranasal Tear Neurostimulator
Medical subject headings: Dry Eye Syndromes, Sjogren's Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03719885
Study group	Role	What they receive
Intervention	Experimental	Not described Receives: Device: TrueTear Intranasal Tear Neurostimulator

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Immediately following the procedure (ie immediately following use of the device)

Secondary outcomes (3)

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.
Measured: Immediately following the procedure (ie immediately following use of the device)
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.
Measured: Immediately following the procedure (ie immediately following use of the device)
Number of Adverse Events
Pain, headache, nosebleed, etc felt to be associated with use of the device
Measured: Immediately following the procedure (ie immediately following use of the device)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 201831 Dec 2019

First posted25 Oct 2018
Study start1 Dec 2018
Primary completion25 Apr 2019
Study completion31 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03719885
Sponsor's protocol ID: 830076
Status last verified: Jul 2023
First submitted: 19 Oct 2018
Last updated: 7 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Not yet recruitingPhase 2
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
Dry Eye Disease (DED), Graft-Versus-Host Disease(GVHD)

All Dry Eye Syndromes trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Controlled Study of Intranasal Tear Neurostimulation for Sjogrens Patients With Dry Eye Disease
ClinicalTrials.gov ID: NCT03719885
Acronym / sponsor ID: 830076
Conditions: Dry Eye Syndromes, Sjogren's Syndrome
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: Allergan
Study start: 1 Dec 2018 (actual)
Primary completion: 25 Apr 2019 (actual)
Study completion: 31 Dec 2019 (actual)
First posted: 25 Oct 2018 (actual)
Results: Posted 25 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Intervention	Experimental	Device: TrueTear Intranasal Tear Neurostimulator

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TrueTear Intranasal Tear NeurostimulatorThis study will evaluate the immediate tear production resulting from use of intranasal tear neurostimulation in patients with Sjogren's disease	Device	Intervention

Primary outcome

Schirmer Testing
Time frame: Immediately following the procedure (ie immediately following use of the device)
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.

3 secondary outcomes

Clinically Significant Changes in Visual Acuity
Time frame: Immediately following the procedure (ie immediately following use of the device)
Clinically Significant Changes in Slit Lamp Exam
Time frame: Immediately following the procedure (ie immediately following use of the device)
Number of Adverse Events
Time frame: Immediately following the procedure (ie immediately following use of the device)

Results and safety

Results posted to the registry on 25 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Study Group	55	35

Primary outcome: Schirmer Testing

Time frame: Immediately following the procedure (ie immediately following use of the device). Mean (Standard Deviation). Unit: mm.

Measure	Intervention n = 35
Cotton Swab	10.2 (1.3)
Extranasal Application	0.8 (0.8)
Intranasal Application	13.5 (1.6)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected throughout the duration of the study (from the time the patient was enrolled in the study until they completed visit 2). We also provided patients with our contact information, in case they experienced any adverse events in the days following visit 2.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Study Group	0 of 55 (0%)	1 of 55 (1.8%)	0 of 55

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Dry Eye Syndromes

Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Not yet recruitingPhase 2
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
Dry Eye Disease (DED), Graft-Versus-Host Disease(GVHD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Giacomina Massaro-Giordano, MD principal investigator

Scheie Eye Insitute, University of Pennsylvania

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing TrueTear Intranasal Tear Neurostimulator in people with Dry Eye Syndromes and Sjogren's Syndrome, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Schirmer Testing (time frame: Immediately following the procedure (ie immediately following use of the device)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03719885.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.