Results from two pivotal multicenter trials demonstrate that an intranasal tear neurostimulator (TrueTear, Allergan) safely and effectively increases endogenous tear production in patients with dry eye disease (DED), said Edward Holland, MD.
“These data support the use of the intranasal tear neurostimulator as a promising treatment option for patients with DED,” said Dr. Holland, director, Cornea Services, Cincinnati Eye Institute, and professor of ophthalmology, University of Cincinnati, Cincinnati, OH.
The handheld device has a rechargeable base unit and a disposable tip with two prongs that are inserted into the nostrils. Small electrical pulses are transmitted to the ends of the tip, stimulating the trigeminal afferent nerve in the nasal mucosa and triggering the nasolacrimal reflex pathway.
The two pivotal studies included a one-day crossover trial that compared active intranasal tear neurostimulator treatment against two controls:
application of a non-electrical sham device with a short, limited insertion tip, and
by patients in a randomized sequence at a single visit.
To be eligible for participation, patients had to have a Schirmer score (with anesthesia) ≤10 mm/5min, a cotton swab stimulated score ≥7 mm higher in the same eye, an Ocular Surface Disease Index (OSDI) score ≥13, and no history of significant nasal or sinus disease.
The study enrolled 48 patients with a mean age of 57 years. They were predominantly female. Baseline unstimulated Schirmer score averaged 5.5 and the mean baseline OSDI score was 41.5.
Effectiveness was analyzed using the Schirmer test to measure stimulated tear production. The results showed that tear production was significantly greater (p < 0.001) during the active intranasal application (~25 mm) compared with both controls (<10 mm).