September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Randomized, controlled, crossover trial comparing the impact of sham or intranasal neurostimulation on conjunctival goblet cell degranulation
Author Affiliations & Notes
  • Koray Gumus
    Cullen Eye Institute, Baylor College of Medicine, Houston, Texas, United States
    Department of Ophthalmology, Erciyes University School of Medicine, Kayseri, Turkey
  • Karri Schuetzle
    Cullen Eye Institute, Baylor College of Medicine, Houston, Texas, United States
  • James D Loudin
    Allergan (Oculeve), South San Francisco, California, United States
  • Stephen C Pflugfelder
    Cullen Eye Institute, Baylor College of Medicine, Houston, Texas, United States
  • Footnotes
    Commercial Relationships   Koray Gumus, None; Karri Schuetzle, None; James Loudin, Allergan (Oculeve) (E); Stephen Pflugfelder, None
  • Footnotes
    Support  Supported by Oculeve
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 2864. doi:
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      Koray Gumus, Karri Schuetzle, James D Loudin, Stephen C Pflugfelder; Randomized, controlled, crossover trial comparing the impact of sham or intranasal neurostimulation on conjunctival goblet cell degranulation. Invest. Ophthalmol. Vis. Sci. 2016;57(12):2864.

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

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Abstract

Purpose : The aim of the study was to investigate the effects of the Oculeve Intranasal Lacrimal Neurostimulator (ILN) on conjunctival goblet cell degranulation.

Methods : A total of 10 participants (5 dry eye and 5 normal “run-in” participants) have been enrolled to date into a three-visit study consisting of one screening examination and two separate application days (extranasal/sham or intranasal neurostimulation) in randomized order. At baseline, all participants underwent ocular surface tests to establish inclusion criteria; tear break-up time ≤ 7 sec, corneal fluorescein and conjunctival lissamine green staining scores of ≥ 3 in one eye, tear meniscus height ≤ 230 μm and nasal stimulated Schirmer score ≥ 7 mm higher than the basal scores. Impression cytology was taken from the temporal (TB) and inferior (IB) bulbar conjunctiva of the right eye for PAS staining and of the left eye for MUC5AC staining at the end of each visit. All membranes were stained and conjunctival goblet cell density (GCD) and the ratio of degranulated to non-degranulated GCs was measured by the same masked observer (K.G).

Results : Among dry eye participants, both IB and TB cytology specimens stained for MUC5AC revealed a significantly higher ratio of degranulated to non-degranulated GCs after the ILN (IB: 1.94 ± 1.16 and TB: 2.14 ± 1.20) compared to baseline (IB: 0.30 ± 0.21, p= 0.042) (TB: 0.52 ± 0.29, p= 0.047) and extranasal sham application (IB: 0.28 ± 0.30, p= 0.040) (TB: 0.46 ± 0.44, p= 0.025). When the same analysis was repeated among the normal participants, similar results were observed. Moreover, while normal subjects had higher ratio of degranulated to non-degranulated GCs at baseline (IB: 0.88 ± 0.64) (TB: 0.60 ± 0.37) compared to the dry eye group (IB: 0.30 ± 0.21) (TB: 0.52 ± 0.29); the ratio became slightly higher in dry eye for the TB region (2.14 ± 1.20 vs. 1.49 ± 0.77 in normals) after the ILN application. There was no significant difference between the IB or TB conjunctiva locations in terms of the effectiveness of the ILN application on conjunctival goblet cell secretory response. These results will be updated at the time of presentation.

Conclusions : These preliminary results document that the Oculeve ILN can stimulate degranulation of conjunctival goblet cells containing MUC5AC, which is a promising new approach for the management of dry eye.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

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