June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017

Quantitation of Tear Production by Tear Meniscus Height Following Acute Use of the Intranasal Tear Neurostimulator
Author Affiliations & Notes
  • Brian Orrick
    Dry Eye, Ora, Inc., Andover, Massachusetts, United States
  • Michael Watson
    Dry Eye, Ora, Inc., Andover, Massachusetts, United States
  • Endri Angjeli
    Dry Eye, Ora, Inc., Andover, Massachusetts, United States
  • Manfred Franke
    Private Consultant, Valencia, California, United States
  • Mark Holdbrook
    Executive Director, Clinical Affairs and Biostatistics, Allergan plc, South San Francisco, California, United States
  • George W Ousler
    Dry Eye, Ora, Inc., Andover, Massachusetts, United States
  • Michelle Senchyna
    Senior Director, Clinical Development, Ophthalmology Therapeutic Area, Allergan, plc, Irvine, California, United States
  • Footnotes
    Commercial Relationships   Brian Orrick, Ora, Inc. (E); Michael Watson, Ora, Inc. (E); Endri Angjeli, Ora, Inc. (E); Manfred Franke, Oculeve, Inc. (P); Mark Holdbrook, Allergan, plc (E); George Ousler, Ora, Inc. (E); Michelle Senchyna, Allergan, plc (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 2692. doi:
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      Brian Orrick, Michael Watson, Endri Angjeli, Manfred Franke, Mark Holdbrook, George W Ousler, Michelle Senchyna;
      Quantitation of Tear Production by Tear Meniscus Height Following Acute Use of the Intranasal Tear Neurostimulator. Invest. Ophthalmol. Vis. Sci. 2017;58(8):2692.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Studies have demonstrated that intranasal stimulation via use of the Intranasal Tear Neurostimulator (ITN)results in a statistically significant increase in tear production measured by the Schirmer’s test. While this test is a clinically relevant and accepted measure, the strip itself absorbs a substantial percentage of the resident and secreted tear volume, confounding repeat measurements over a discrete time frame. Tear meniscus height (TMH) as captured by optical coherence tomography (OCT) has been established as a non-invasive and accurate measure of tear quantity and production. The objective of this study was to compare the change in TMH between pre- and post-ITN vs extranasal (control) applications.

Methods : 25 dry eye subjects were enrolled in acrossover,4-visit study consisting of one screening examination (V1) and 3 application visits (V2-V4). At V2, subjects received two applications of approximately 3 minutes each (ITN or extranasal control) in randomized order, with tear production measured via the unanesthetized Schirmer’s test. At V3 and V4, subjects received a single treatment (ITN or extranasal control) in randomized order with TMH captured prior to and immediately following ~2 minutes of application (Heidelberg Spectralis).All data are shown as Mean±SD. Mean data were compared using a paired t-test. P-values <0.05 were considered statistically significant.

Results : Mean tear production at V2 was 25.9±9.8 mm and 5.8±4.9 mm post-stimulation with the ITN and extranasal control, respectively. The mean paired difference, 20.1±9.2 mm, was statistically significant (p<0.0001). Consistent with these results, mean change in TMH (post- minus pre-stimulation), for the INT and the extranasal control application was 449±543 µm and 56±198 µm, respectively. The mean paired difference in TMH change between the INT and extranasal control, 394±520 µm, was also statistically significant (p=0.002).

Conclusions : Use of the ITN results in a statistically significant increase in acute tear production in dry eye subjects as measured by both the Schirmer’s test and TMH captured by OCT. Assessment of TMH provides a non-invasive option for future studies aimed at further characterizing tear production stimulated by ITN.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

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