The second study included 97 patients. It was a 180-day, open-label trial that compared changes in Schirmer score before and during intranasal stimulation when measured at baseline and after 7, 30, 90, and 180 (primary outcome) days.
Eligibility for this study used the same Schirmer score and cotton swab stimulated score criteria, but required an OSDI ≥23, corneal fluorescein staining (CFS) score ≥2 in at least one of five corneal regions, and a sum (CFS) score ≥4 for all corneal regions in the same eye.
At baseline, mean CFS score was 7.5 in study eyes and the mean OSDI score was 52.
Data on device usage showed that patients applied the treatment an average of 1.7 times per day for an average application time of 2.2 minutes/day. The mean number of treatment applications per subject over the 6-month study period was 288, Dr. Holland reported.
“Patients were instructed to use the [device] a minimum of 2 times daily and up to 10 times a day as needed and for no more than 3 minutes per use,” he said.
The primary endpoint analysis showed the treatment significantly increased acute tear production at 180 days (p < 0.0001). Secondary efficacy analyses showed there was a statistically significant treatment effect at all other visits.
“The data from this study corroborate the significant increase in acute tear production found in the single day study and demonstrate the durability of the response,” Dr. Holland said.