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Intranasal tear neurostimulation increases acute tear production

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Edward J. Holland

NEW ORLEANS — Data from two studies reinforce the finding that intranasal tear neurostimulation results in significantly increased acute tear production compared with either active extranasal or sham intranasal applications, a speaker said.

“As we’ve learned over the last few years, stimulation of the trigeminal afferent nerve in the nasal mucosa triggers the nasolacrimal reflex pathway, and this contributes both to basal and stimulated tear production,” Edward J. Holland, MD, said at the American Academy of Ophthalmology meeting. “The intranasal tear neurostimulator (TrueTear, Allergan) delivers a small electrical current to the nasal cavity and stimulates this pathway, this potential treatment for dry eye.”

In one prospective, randomized, double-masked, crossover 1-day study in 48 patients, subjects received three test applications in random sequence of active intranasal, active extranasal control and sham intranasal control. Significantly greater tear production was observed during active intranasal application vs. either control (P < .0001). Four subjects (8%) reported mild and transient adverse events.

In a second study — a prospective, single-arm, open-label study — 97 subjects were instructed to use the device a minimum of twice a day and up to 10 times per day for up to 180 days. Mean number of applications per subject was 288 over the study period.

Acute tear production was significantly greater during intranasal stimulation in the study eye vs. the unstimulated fellow eye at 180 days and at all other visits (P < .0001). Nasal pain and discomfort or burning was the most often reported adverse event related to the device.

“Certainly, these data demonstrate that the ITN effectively and safely increases endogenous tear production and supports the use of the ITN as a promising treatment option for patients with dry eye,” Holland said. – by Patricia Nale, ELS

Reference:

Holland EJ. Intranasal tear neurostimulation for subjects with dry eye disease: Results from 2 pivotal clinical trials. Presented at American Academy of Ophthalmology annual meeting; Nov. 11-14, 2017; New Orleans.

Disclosure: Holland reports he is a consultant for Allergan and receives research funding from Allergan. The study was sponsored by Allergan.