Trial Outcomes & Findings for TrueTear in Sjogren's Disease Patients (NCT NCT03719885)
NCT ID: NCT03719885
Last Updated: 2023-07-07
Results Overview
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.
COMPLETED
NA
55 participants
Immediately following the procedure (ie immediately following use of the device)
2023-07-07
Participant Flow
Participant milestones
| Measure |
Study Group
The participants recruited for this study were those who were 22 years or older, 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). They also had to have an OSDI score ≥13.
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|---|---|
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Overall Study
STARTED
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55
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Overall Study
COMPLETED
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35
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Overall Study
NOT COMPLETED
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20
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TrueTear in Sjogren's Disease Patients
Baseline characteristics by cohort
| Measure |
Study Group
n=35 Participants
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).
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|---|---|
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Age, Continuous
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57.1 years
STANDARD_DEVIATION 11.4 • n=5 Participants
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Sex: Female, Male
Female
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35 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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33 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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2 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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5 Participants
n=5 Participants
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Race (NIH/OMB)
White
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26 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=5 Participants
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Year of Sjogren's diagnosis
Prior to 2000
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3 Participants
n=5 Participants
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Year of Sjogren's diagnosis
2000 - 2010
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11 Participants
n=5 Participants
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Year of Sjogren's diagnosis
After 2010
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21 Participants
n=5 Participants
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OSDI Score
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50.5 units on a scale
STANDARD_DEVIATION 21 • n=5 Participants
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intervention
n=35 Participants
TrueTear Intranasal Tear Neurostimulator: This study will evaluate the difference between active and control applications in tear production during active stimulation as measured by Schirmer testing
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|---|---|
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Schirmer Testing
Cotton Swab
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10.2 mm.
Standard Deviation 1.3
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Schirmer Testing
Extranasal Application
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0.8 mm.
Standard Deviation 0.8
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Schirmer Testing
Intranasal Application
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13.5 mm.
Standard Deviation 1.6
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SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Intervention
n=35 Participants
TrueTear Intranasal Tear Neurostimulator: This study will evaluate the difference between active and control applications in tear production during active stimulation as measured by Schirmer testing
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|---|---|
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Clinically Significant Changes in Visual Acuity
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0 Participants
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SECONDARY outcome
Timeframe: 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
Clinically significant changes in slit lamp examination . Subjects who experienced clinically significant changes would be represented in the data table below.
Outcome measures
| Measure |
Intervention
n=35 Participants
TrueTear Intranasal Tear Neurostimulator: This study will evaluate the difference between active and control applications in tear production during active stimulation as measured by Schirmer testing
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|---|---|
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Clinically Significant Changes in Slit Lamp Exam
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0 Participants
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SECONDARY outcome
Timeframe: Immediately following the procedure (ie immediately following use of the device)Population: All participants who used the device were observed for any adverse events
Pain, headache, nosebleed, etc felt to be associated with use of the device
Outcome measures
| Measure |
Intervention
n=35 Participants
TrueTear Intranasal Tear Neurostimulator: This study will evaluate the difference between active and control applications in tear production during active stimulation as measured by Schirmer testing
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|---|---|
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Number of Adverse Events
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1 occurance of adverse event
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Adverse Events
Study Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Study Group
n=55 participants at risk
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).
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|---|---|
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Eye disorders
Small conjunctival hemorrhage
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1.8%
1/55 • 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.
The adverse event data was collected immediately following the event. The subject was also called a week later to ensure that the issue had resolved.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place