Dry Eye Syndromes, Sjogren's Syndrome
Conditions
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.
Interventions
DEVICETrueTear Intranasal Tear Neurostimulator
This study will evaluate the immediate tear production resulting from use of intranasal tear neurostimulation in patients with Sjogren's disease
Sponsors
Allergan
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Schirmer Testing | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinically Significant Changes in Visual Acuity | Immediately following the procedure (ie immediately following use of the device) | 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 | Immediately following the procedure (ie immediately following use of the device) | 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 | Immediately following the procedure (ie immediately following use of the device) | Pain, headache, nosebleed, etc felt to be associated with use of the device |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Group The participants recruited for this study were those who had a clinical diagnosis of Sjogren's Syndrome (SS) and produced 10 mm. or less of tears over the course of 5 minutes (measured using Schirmer strips). | 35 |
| Total | 35 |
Baseline characteristics
| Characteristic | Study Group |
|---|---|
| Age, Continuous | 57.1 years STANDARD_DEVIATION 11.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| OSDI Score | 50.5 units on a scale STANDARD_DEVIATION 21 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 26 Participants |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 0 Participants |
| Year of Sjogren's diagnosis 2000 - 2010 | 11 Participants |
| Year of Sjogren's diagnosis After 2010 | 21 Participants |
| Year of Sjogren's diagnosis Prior to 2000 | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 55 |
| other Total, other adverse events | 1 / 55 |
| serious Total, serious adverse events | 0 / 55 |
Outcome results
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.
Time frame: Immediately following the procedure (ie immediately following use of the device)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Schirmer Testing | Cotton Swab | 10.2 mm. | Standard Deviation 1.3 |
| Intervention | Schirmer Testing | Extranasal Application | 0.8 mm. | Standard Deviation 0.8 |
| Intervention | Schirmer Testing | Intranasal Application | 13.5 mm. | Standard Deviation 1.6 |
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.
Time frame: Immediately following the procedure (ie immediately following use of the device)
Population: Eyes were examined pre and post active application to confirm that the device did not cause any changes to the physical structure or appearance of the eyes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Clinically Significant Changes in Slit Lamp Exam | 0 Participants |
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.
Time frame: Immediately following the procedure (ie immediately following use of the device)
Population: Participants' eyes were examined pre and post active application to confirm that the device did not cause any changes to the participant's vision. A serious change in vision would have been reported as an adverse event
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Clinically Significant Changes in Visual Acuity | 0 Participants |
Secondary
Number of Adverse Events
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)
Population: All participants who used the device were observed for any adverse events
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Number of Adverse Events | 1 occurance of adverse event |