PMID- 30629728 OWN - NLM STAT- MEDLINE DCOM- 20190624 LR - 20190624 IS - 1552-5783 (Electronic) IS - 0146-0404 (Linking) VI - 60 IP - 1 DP - 2019 Jan 2 TI - Randomized, Controlled, Double-Masked, Multicenter, Pilot Study Evaluating Safety and Efficacy of Intranasal Neurostimulation for Dry Eye Disease. PG - 147-153 LID - 10.1167/iovs.18-23984 [doi] AB - 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 /=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. FAU - Cohn, Geoffrey S AU - Cohn GS AD - Eye Associates, Sydney, Australia. FAU - Corbett, Dean AU - Corbett D AD - Auckland Eye Ltd, Auckland, New Zealand. FAU - Tenen, Abi AU - Tenen A AD - Vision Eye Institute, Melbourne, Australia. FAU - Coroneo, Minas AU - Coroneo M AD - University of South Wales (UNSW), Prof M.T. Coroneo Pty. Ltd., Randwick, Australia. FAU - McAlister, James AU - McAlister J AD - Griffith University, Upper Mt. Gravatt, Australia. FAU - Craig, Jennifer P AU - Craig JP AD - Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, Auckland, New Zealand. FAU - Gray, Trevor AU - Gray T AD - Eye Institute, Auckland, New Zealand. FAU - Kent, David AU - Kent D AD - Fendalton Eye Clinic, Fendalton, New Zealand. FAU - Murray, Neil AU - Murray N AD - Rotorua Eye Clinic, Rotorua, New Zealand. FAU - Petsoglou, Con AU - Petsoglou C AD - Sydney Eye Specialist Centre, Kingsford, Australia. FAU - Baba, Stephanie N AU - Baba SN AD - Allergan plc, Irvine, California, United States. FAU - Holland, Edward J AU - Holland EJ AD - Cincinnati Eye Institute and University of Cincinnati, Union, Kentucky, United States. LA - eng SI - ANZCTR/ACTRN12613001110774 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - Invest Ophthalmol Vis Sci JT - Investigative ophthalmology & visual science JID - 7703701 SB - IM MH - Adult MH - Aged MH - Double-Blind Method MH - Dry Eye Syndromes/metabolism/*therapy MH - Female MH - Humans MH - Male MH - Middle Aged MH - Nasal Mucosa/*innervation MH - Pilot Projects MH - Prospective Studies MH - Protective Devices MH - Slit Lamp Microscopy MH - Tears/*physiology MH - Transcutaneous Electric Nerve Stimulation/adverse effects/*methods EDAT- 2019/01/11 06:00 MHDA- 2019/06/25 06:00 CRDT- 2019/01/11 06:00 PHST- 2019/01/11 06:00 [entrez] PHST- 2019/01/11 06:00 [pubmed] PHST- 2019/06/25 06:00 [medline] AID - 2720804 [pii] AID - 10.1167/iovs.18-23984 [doi] PST - ppublish SO - Invest Ophthalmol Vis Sci. 2019 Jan 2;60(1):147-153. doi: 10.1167/iovs.18-23984.