User Guide

25
were shown to have meaningful improvement in their symptoms. There were
more subjects with severe dry eye symptoms that had a meaningful improvement in
symptoms from baseline as measured with the OSDI than the number with meaningful
worsening of symptoms at day 7 and at day 30.
Safety and effectiveness of intranasal electrical stimulation was evaluated over a 6-month
period of time. The safety and effectiveness of the TrueTear
®
device for longer periods of
use has not been established.
In this study, safety was acceptable with no serious adverse events that were
largely nasal in nature. The types and percentages for each type of AEs are presented
in Table 1.
All device-related AEs (mostly mild discomfort or nosebleed) were evident to the
patients and therefore self-limiting (with the exception of one case of chapped skin
around the nostrils which resolved with over-the-counter medication) since patients
could remove the device and discontinue stimulation at any time. The incidence of
device-related AEs decreased over the course of the study, with the highest number
occurring in the rst month.
Table 1. Proportion of Study Patients Experiencing Adverse Event Related or Possibly
Related to TrueTear® Device
Adverse Event Description
Number of Study Patients
(Number of patients = 97)
Percentage
Nasal pain, discomfort, or burning 10 10.3%
Temporary electrical discomfort 5 5.2%
Nosebleed 5 5.2%
Nasal congestion 3 3.1%
Headaches 2 2.1%
Trace blood in nostril 2 2.1%
Facial pain 2 2.1%
Sore eye 1 1.0%
Sinus pain 1 1.0%
Pain around the eye 1 1.0%
Runny nose 1 1.0%
Nasal ulcers 1 1.0%
Lightheadedness 1 1.0%
*Some patients had more than one adverse event.
The device was applied for an average of 1.7 times per day with an average daily
application time of 130 seconds/day (2.16 minutes/day). Subjects applied the device
a total of 27,338 times during the study, and the total device application time for the study
was 34,726 minutes. Therefore, this small number of device-related mild AEs occurred in a
large number of stimulation events. In all, 30 study patients (30.9% of those studied) had at
least one of the adverse events listed in the above table.
Figure 11. Acute tear production at day 180.