User Guide

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The direct clinical benet of temporarily increasing tear production as a therapy
for patients with dry eye disease was not assessed as part of this clinical trial.
There were no adverse events that led to discontinuation from the study. Two
adverse events were deemed related to or possibly related to the TrueTear
®
device. These included transient lightheadedness and intermittent nose itching.
No changes of nasal tissue were observed with examination of the nasal cavity.
CLINICAL STUDY OCUN-010—6-MONTH STUDY
This study was designed to evaluate the safety and effectiveness of the TrueTear
®
device to increase tear production at multiple time points during the study (Baseline
and 7, 30, 90, and 180 days) for patients with dry eye symptoms.
Eligibility for enrollment in this study required potential participants to be 22 years of
age or older and have Dry Eye based on the level of dryness in the eye(s) measured
on a dry eye symptom scale.
Potential participants were excluded from the study if the surface of the cornea had
severe irregularities due to dry eye disease; if they had bleeding from the nose
or previous sinus surgery or trauma; if they had coagulation problems (bleeding
problems), a cardiac pacemaker, implanted debrillators or another implanted
electronic device. Potential study participants with disabling arthritis or limited
motor coordination were also excluded from participating in the study since these
conditions could interfere with use of the TrueTear
®
device.
0.0
5.0
10.0
15.0
20.0
25.0
30.0
35.0
40.0
Intranasal Sham Extranasal
Schirmer Score (mm)
Application
Schirmer Scores - Study Eye
Intranasal
a
Sham
b
Extranasal
Application
c
Figure 10. Tear production score (Schirmer).
a
Intranasal = TrueTear® device applied correctly inside the nose
b
Sham = Inactive TrueTear® device applied inside the nose
c
Extranasal = TrueTear® device applied outside of the nose with stimulation