Allergan, best known as a pharma firm, won FDA marketing clearance to introduce its new TrueTear intranasal neurostimulator. The device is designed to boost the production of tears by sending a controlled electric current between its electrodes that in turn stimulates the lacrimal gland.
The device comes with a bunch hydrogel slip-on tips that can be thrown away after each use. After putting one a set, the tips are inserted into the nasal cavity and the device is activated to begin therapy delivery. The user can choose the strength of the stimulation and the length of each treatment.
Some details about the studyies that led to this clearance, according to Allergan:
Study 1 is a prospective, randomized, controlled, double-masked, multicenter, cross-over trial in which participants used an active device and two control applications. The primary effectiveness endpoint of increased tear production during intranasal application as measured by Schirmer score compared to both controls was met. Study 2 is a prospective, single-arm, multicenter, open-label clinical trial in which participants used TrueTear™ to stimulate tear production for 180 days. The primary effectiveness endpoint of increased tear production as measured by Schirmer score during application of the device compared with basal Schirmer score at Day 180 was met. Secondary endpoints of increased tear production as measured by Schirmer score during application of the device compared with basal Schirmer score at Days 0, 7, 30 and 90 were also met. The direct clinical benefit of temporarily increasing tear production as a therapy for patients with dry eye disease was not assessed as part of these clinical trials. All device-related adverse events were mild in nature. There were no device-related serious adverse events.
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