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Clinical Trial
. 2020 Nov 17;9(12):23.
doi: 10.1167/tvst.9.12.23. eCollection 2020 Nov.

Novel Extranasal Tear Stimulation: Pivotal Study Results

Marco H Ji  1   2 , Darius M Moshfeghi  1 , Laura Periman  3 , David Kading  4 , Cynthia Matossian  5 , Gerald Walman  6 , Scott Markham  7 , Andy Mu  8 , Ann Jayaram  9 , Michael Gertner  10 , Paul Karpecki  11 , Neil J Friedman  9
Affiliations
Clinical Trial

Novel Extranasal Tear Stimulation: Pivotal Study Results

Marco H Ji et al. Transl Vis Sci Technol. .

Abstract

Purpose: To evaluate the efficacy and safety of iTEAR, a novel, portable, sonic external neuromodulation device, for the treatment of dry eye disease (DED).

Methods: This was a multicenter, open-label, single-arm clinical trial that included adult patients with DED with a Schirmer score of ≤10 mm in at least one eye. Enrolled subjects were instructed to apply the study device at least twice per day for 30 seconds bilaterally to the external nasal nerve. After the initial baseline visit, patients were followed up at days 3, 14, 30, 90, and 180. The primary efficacy endpoint was the Schirmer index (change from unstimulated to stimulated tear production as measured by the Schirmer test) at day 30. The major secondary endpoint was the change in symptoms of DED at day 30 evaluated using the Ocular Surface Disease Index (OSDI).

Results: A total of 101 subjects evaluated at day 30 had a mean Schirmer index of 9.4 mm (95% confidence interval [CI], 7.4-11.3), and the baseline OSDI improved by an average of 14.4 (95% CI, 11.1-17.7). Both endpoints were highly statistically and clinically significant at all time points. There were two mild unanticipated adverse events definitely related to the device.

Conclusions: The safety and efficacy of the iTEAR device observed in this study support its indication for treating DED.

Translational relevance: Neurostimulation has the potential to improve signs and symptoms of DED.

Keywords: dry eye disease; dry eyes; lacrimal gland; neurostimulation.

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Conflict of interest statement

Disclosure: M.H. Ji, None; D.M. Moshfeghi, None; L. Periman (C); D. Kading (C); C. Matossian, None; G. Walman, None; S. Markham, None; A. Mu, None; A. Jayaram, None; M. Gertner, Olympic Ophthalmics, Inc. (F, I); P. Karpecki (C); N.J. Friedman (C, I)

Figures

Figure 1.
Figure 1.
Pathway of the nasolacrimal reflex beginning with the anterior ethmoidal nerve or, as shown in this study, the external nasal nerve. Reprinted with permission from Dieckmann G, Fregni F, Hamrah P. Neurostimulation in dry eye disease-past, present, and future. Ocul Surf. 2019;17(1):20–27.
Figure 2.
Figure 2.
Location of the external branch of the anterior ethmoidal nerve (external nasal nerve). Reprinted with permission from Lal D, Gnagi SH. Nose anesthesia. Medscape, https://emedicine.medscape.com/article/82679-overview.
Figure 3.
Figure 3.
Commercial iTEAR100 device. The arrow denotes the oscillating tip with curvature and edge designed for chronic repetitive stimulation of the external nasal nerve.
Figure 4.
Figure 4.
The primary endpoint of the study showing the pre-stimulation versus post-stimulation Schirmer score values.
Figure 5.
Figure 5.
The secondary endpoint of the study showing OSDI scores at each time point.
See this image and copyright information in PMC

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