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dc.contributor.authorCohn, Geoffrey S
dc.contributor.authorCorbett, Dean
dc.contributor.authorTenen, Abi
dc.contributor.authorCoroneo, Minas
dc.contributor.authorMcAlister, James
dc.contributor.authorCraig, Jennifer P
dc.contributor.authorGray, Trevor
dc.contributor.authorKent, David
dc.contributor.authorMurray, Neil
dc.contributor.authorPetsoglou, Con
dc.contributor.authorBaba, Stephanie N
dc.contributor.authorHolland, Edward J
dc.date.accessioned2020-02-28T00:52:40Z
dc.date.available2020-02-28T00:52:40Z
dc.date.issued2019
dc.identifier.issn0146-0404
dc.identifier.doi10.1167/iovs.18-23984
dc.identifier.urihttp://hdl.handle.net/10072/391998
dc.description.abstractPurpose: 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.
dc.description.peerreviewedYes
dc.languageEnglish
dc.publisherAssociation for Research in Vision and Ophthalmology
dc.relation.ispartofpagefrom147
dc.relation.ispartofpageto153
dc.relation.ispartofissue1
dc.relation.ispartofjournalInvestigative Ophthalmology & Visual Science
dc.relation.ispartofvolume60
dc.subject.fieldofresearchBiological Sciences
dc.subject.fieldofresearchMedical and Health Sciences
dc.subject.fieldofresearchcode06
dc.subject.fieldofresearchcode11
dc.subject.keywordsScience & Technology
dc.subject.keywordsLife Sciences & Biomedicine
dc.subject.keywordsOphthalmology
dc.subject.keywordsdry eye disease
dc.subject.keywordsEPIDEMIOLOGY
dc.titleRandomized, Controlled, Double-Masked, Multicenter, Pilot Study Evaluating Safety and Efficacy of Intranasal Neurostimulation for Dry Eye Disease
dc.typeJournal article
dc.type.descriptionC1 - Articles
dcterms.bibliographicCitationCohn, GS; Corbett, D; Tenen, A; Coroneo, M; McAlister, J; Craig, JP; Gray, T; Kent, D; Murray, N; Petsoglou, C; Baba, SN; Holland, EJ, Randomized, Controlled, Double-Masked, Multicenter, Pilot Study Evaluating Safety and Efficacy of Intranasal Neurostimulation for Dry Eye Disease, Investigative Ophthalmology & Visual Science, 2019, 60 (1), pp. 147-153
dcterms.licensehttp://creativecommons.org/licenses/by/4.0
dc.date.updated2020-02-28T00:48:14Z
dc.description.versionPublished
gro.rights.copyright© 2019, The Author(s). This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 International License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
gro.hasfulltextFull Text
gro.griffith.authorMcAlister, James C.


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