User Guide

22
Summary of Clinical Studies
Two pivotal clinical studies have been conducted with the TrueTear
®
device. Both studies
evaluated the device’s safety and effectiveness in dry eye patients. Both pivotal studies
(OCUN-009 and OCUN-010) demonstrated the device’s capability temporarily to
increase tear production during stimulation. OCUN-010 also demonstrated the TrueTear
®
device’s capability to improve dry eye symptoms as a result of stimulation.
The next section summarizes both pivotal studies.
CLINICAL STUDY OCUN-009—SINGLE STUDY VISIT
(ONE-TIME USE)
This clinical study was designed to evaluate the effectiveness and safety of the TrueTear
®
device during use at a single study visit.
To qualify for enrollment in this study, potential participants were required to be 22 years
of age or older and have dry eye symptoms 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 demand pacemaker, implanted debrillator, 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.
This study was conducted at two sites in the United States, and 48 people were
tested. The study population, on average, was 57 years old. The majority of people
who participated in the study were female. Each patient in the study underwent three
applications of stimulation. On the study day visit, each subject received 3 applications
in random order, with the TrueTear
®
device applied correctly, i.e., inside the nose, an
inactive TrueTear
®
device applied inside the nose, i.e., no stimulation, and the TrueTear
®
device applied outside of the nose with stimulation.
In this study, the TrueTear
®
device used as intended resulted in a large increase in tear
production. This is shown in the graph in Figure 13. The average Schirmer score (a
standard measurement of Dry Eye that measures tear production) was approximately
25 mm during neurostimulation, compared with approximately 9 mm , i.e., less tear
production, for the inactive control application and in people who used the TrueTear
®
device on the outside of the nose, where it would not be effective.