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Invest Ophthalmol Vis Sci. 2019 Jan 2;60(1):147-153. doi: 10.1167/iovs.18-23984.

Randomized, Controlled, Double-Masked, Multicenter, Pilot Study Evaluating Safety and Efficacy of Intranasal Neurostimulation for Dry Eye Disease.

Author information

1
Eye Associates, Sydney, Australia.
2
Auckland Eye Ltd, Auckland, New Zealand.
3
Vision Eye Institute, Melbourne, Australia.
4
University of South Wales (UNSW), Prof M.T. Coroneo Pty. Ltd., Randwick, Australia.
5
Griffith University, Upper Mt. Gravatt, Australia.
6
Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, Auckland, New Zealand.
7
Eye Institute, Auckland, New Zealand.
8
Fendalton Eye Clinic, Fendalton, New Zealand.
9
Rotorua Eye Clinic, Rotorua, New Zealand.
10
Sydney Eye Specialist Centre, Kingsford, Australia.
11
Allergan plc, Irvine, California, United States.
12
Cincinnati Eye Institute and University of Cincinnati, Union, Kentucky, United States.

Abstract

Purpose:

We assess the safety and effectiveness of intranasal neurostimulation to promote tear production via the nasolacrimal pathway in subjects with dry eye disease.

Methods:

A multicenter, randomized, controlled, double-masked pilot study was conducted in adults with dry eye diagnosis and at least one eye with corneal fluorescein staining ≥2 in at least one region or a sum of all regions ≥5 (National Eye Institute grading), basal Schirmer test score ≤10 mm, a cotton-swab stimulated Schirmer score ≥7 mm higher, and an Ocular Surface Disease Index score ≥23. Subjects were randomized to receive active intranasal neurostimulation or sham control intranasal stimulation 4 to 8 times per day. Assessments were scheduled before (unstimulated) and during (stimulated) device application at days 0, 7, 14, 30, and 90. The primary effectiveness endpoint was stimulation-induced change in Schirmer test (with anesthesia) score. Primary safety measure was incidence of device-related adverse events (AEs).

Results:

Fifty-eight subjects were randomized at nine sites in Australia and New Zealand; 56 completed the 90-day study. Stimulation-induced change in Schirmer score was significantly greater with active intranasal (mean ± SEM, 9.0 ± 2.0) than sham control intranasal stimulation (0.4 ± 0.6; P < 0.001) at day 90. Similar results were observed at days 0, 7, 14, and 30 (P < 0.001). No serious device-related AEs were observed. Mild nosebleed, the most common device-related AE, was reported in five (16.7%) subjects.

Conclusions:

Intranasal neurostimulation was effective in inducing acute tear production after 90 days of use and generally was well tolerated in subjects with dry eye disease.

PMID:
30629728
DOI:
10.1167/iovs.18-23984

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