Neurostimulator increases tear production

CHICAGO – Two studies showed that the intranasal tear neurostimulator produced a significant increase in acute tear production, according to a poster presented at the American Academy of Optometry meeting.

Evans and colleagues conducted a 1-day crossover study and a 180-day open-label study of Allergan’s TrueTear device.

They explained in the poster that the TrueTear transmits small electrical pulses to the disposable tip, which is inserted into the nostrils to make contact with the anterior nasal mucosa. The intensity of the stimulation can be adjusted from 0 to 5.

The prospective, randomized, double-masked, dual-controlled, crossover

study was conducted at two U.S. sites, according to the poster. Subjects were considered eligible if they had baseline Schirmer’s scores of no more than 10 mm/5 minutes, cotton swab stimulated scores of at least 7 mm higher and Ocular Surface Disease Index (OSDI) total scores of at least 13. In 1 day, the subjects randomly received one active intranasal application, one active extranasal application and sham intranasal controls.

Forty-eight subjects, most of whom were women, completed the study. Mean age was 56.9 years.

The researchers reported in the poster that the active intranasal stimulation induced significantly greater tear production than the other two methods. One subject reported intermittent nose itching, and one reported lightheadedness, which may or may not have been related to the device.

The 180-day open-label study was conducted at three sites. Subjects were considered eligible if they had Schirmer’s scores of no more than 10 mm/5 minutes, fluorescein staining score of at least 2 in at least one of five regions, a sum of 4 or more for all regions in one eye and a baseline OSDI score of at least 23.

Eighty-nine subjects completed the study. Mean age was 61.1 years, and the majority were women. Subjects were evaluated at six visits, ranging from the screening to 180 days.

According to the poster, the participants were instructed to use the intranasal tear neurostimulator (ITN) at least twice a day and up to 10 times a day as needed, for no more than 3 minutes at a time. The mean number of applications of the TrueTear device per subject was 288 over the study period.

The researchers stated that “acute tear production was significantly greater during intranasal stimulation vs. unstimulated at 180 days and all other study visits.”

The mean Schirmer’s score during stimulation was 17.3 mm vs. 7.9 mm prior to stimulation, an increase of 10.4 mm at day 180.

A total of 126 adverse events were reported in about 60% of subjects, with 31% considered related to the device and the majority considered mild to moderate.

“The significant increase in acute tear production found in study 1 was reproduced in study 2,” the authors reported, “which also demonstrated the durability of this response in that following 180 days of daily use; stimulation with the ITN maintained the ability to significantly increase tear production.” – by Nancy Hemphill, ELS, FAAO

Reference:

Evans D, et al. Effectiveness and safety of intranasal tear neurostimulation for subjects with dry eye disease. Presented at: American Academy of Optometry meeting; Chicago; Oct. 10-14, 2017.

Disclosures: The studies were sponsored by Allergan. Evans reported he has received research funding from Alcon, Allergan, Auven Therapeutics, Encore Vision Inc., Johnson & Johnson Vision and Kala Pharmaceuticals. Please see the full study for all author’s financial disclosures.