User Guide

Eligible participants were enrolled in the study and provided with a TrueTear

device for

home use. Participants were instructed to use the TrueTear

device at least two times a day

and as often as 10 times per day, as needed, and no more than three minutes per use. Study

participants were examined at Baseline and days 7, 30, 90, and 180.

Ninety-seven (97) people with dry eye symptoms were enrolled at three sites in the U.S. The

study population, on average, was 61 years old, and the majority of people who participated in

the study were females.

Tear production at Baseline and each follow-up visit including 180 days (6 months) is shown

in Figure 11. At 180 days, the study participants used the TrueTear

device with active

stimulation and then without stimulation to evaluate whether there was a difference in tear

production with and without active stimulation. In this study, tear production was much

greater with active stimulation than without stimulation. In comparing the stimulated vs

unstimulated tear production during the study, following the initial stimulation, there was a

trend toward decreased effectiveness (tear production) with time with the use of the TrueTear

device; this trend appeared to plateau toward the end of the study. The mechanism for this

decrease has not been identied and was not analyzed as part of the study. The average

difference in Schirmer score (stimulated vs unstimulated) was 18.0 mm at Baseline (the rst

day of use), 13.1 mm at day 7, 8.1 mm at day 30, 8.3 mm at day 90, and 9.4 mm at day 180.

Symptom improvement from the start of the study was assessed at study day 7 and day 30

using a commonly used questionnaire called the Ocular Surface Disease Index (OSDI). Of the

97 subjects enrolled, 77 had severe dry eye symptoms at the start of the study and were seen

following treatment. Of these subjects, between 18 (23%) and 33 (43%)

Figure 11. Acute tear production at day 180.