Koray Gumus1, Karri L Schuetzle2, Stephen C Pflugfelder3. 1. Cullen Eye Institute, Baylor College of Medicine, Houston, Texas; Erciyes University School of Medicine, Department of Ophthalmology, Kayseri, Turkey. 2. Cullen Eye Institute, Baylor College of Medicine, Houston, Texas. 3. Cullen Eye Institute, Baylor College of Medicine, Houston, Texas. Electronic address: stevenp@bcm.edu.
Abstract
PURPOSE: The aim of the study was to investigate the effects of the Allergan Intranasal Tear Neurostimulator (ITN) on conjunctival goblet cell (GC) degranulation. DESIGN: A randomized, double-masked, placebo-controlled crossover trial. METHODS: A total of 15 subjects (5 normal and 10 dry eye) were enrolled in a 3-visit study consisting of 1 screening and 2separate randomized-masked ITN treatments (sham extranasal or intranasal). Tear meniscus height (TMH) was measured by anterior segment optical coherence tomography before and after applications. Impression cytology (IC) was taken from the bulbar conjunctiva of the right eye for periodic acid-Schiff staining and from the left eye for MUC5AC mucin immunostaining at baseline and after each treatment. The ratio of degranulated to nondegranulated GCs was measured as a marker of secretion. RESULTS: In all participants, both inferior bulbar (IB) and temporal bulbar (TB) cytology specimens stained for MUC5AC revealed a significantly higher ratio of degranulated to nondegranulated GCs after the ITN (IB: 2.28 ± 1.27 and TB: 1.81 ± 1.01) compared to baseline (IB: 0.56 ± 0.55, P = .015) (TB: 0.56 ± 0.32, P = .003) and extranasal sham application (IB: 0.37 ± 0.29, P = .001) (TB: 0.39 ± 0.33, P = .001). When the same analysis was repeated in the dry eye or control groups, the ratio was significantly higher after ITN than the baseline ratio and ratio after extranasal application in both groups (P < .05). Moreover, although control subjects had a higher ratio of degranulated to nondegranulated GCs at baseline (0.75 ± 0.52) compared with the dry eye group (0.41 ± 0.27), the ratio became slightly higher in dry eye (2.04 ± 1.12 vs 1.99 ± 1.21 in control) after the ITN application. There was no significant difference between the IB or TB conjunctiva locations in terms of the effectiveness of the ITN application on conjunctival goblet cell secretory response. CONCLUSIONS: These preliminary results document that the Allergan ITN can stimulate degranulation of goblet cells in the conjunctiva, which is a promising new approach for the management of dry eye.
RCT Entities:
PURPOSE: The aim of the study was to investigate the effects of the Allergan Intranasal Tear Neurostimulator (ITN) on conjunctival goblet cell (GC) degranulation. DESIGN: A randomized, double-masked, placebo-controlled crossover trial. METHODS: A total of 15 subjects (5 normal and 10 dry eye) were enrolled in a 3-visit study consisting of 1 screening and 2 separate randomized-masked ITN treatments (sham extranasal or intranasal). Tear meniscus height (TMH) was measured by anterior segment optical coherence tomography before and after applications. Impression cytology (IC) was taken from the bulbar conjunctiva of the right eye for periodic acid-Schiff staining and from the left eye for MUC5ACmucin immunostaining at baseline and after each treatment. The ratio of degranulated to nondegranulated GCs was measured as a marker of secretion. RESULTS: In all participants, both inferior bulbar (IB) and temporal bulbar (TB) cytology specimens stained for MUC5AC revealed a significantly higher ratio of degranulated to nondegranulated GCs after the ITN (IB: 2.28 ± 1.27 and TB: 1.81 ± 1.01) compared to baseline (IB: 0.56 ± 0.55, P = .015) (TB: 0.56 ± 0.32, P = .003) and extranasal sham application (IB: 0.37 ± 0.29, P = .001) (TB: 0.39 ± 0.33, P = .001). When the same analysis was repeated in the dry eye or control groups, the ratio was significantly higher after ITN than the baseline ratio and ratio after extranasal application in both groups (P < .05). Moreover, although control subjects had a higher ratio of degranulated to nondegranulated GCs at baseline (0.75 ± 0.52) compared with the dry eye group (0.41 ± 0.27), the ratio became slightly higher in dry eye (2.04 ± 1.12 vs 1.99 ± 1.21 in control) after the ITN application. There was no significant difference between the IB or TB conjunctiva locations in terms of the effectiveness of the ITN application on conjunctival goblet cell secretory response. CONCLUSIONS: These preliminary results document that the Allergan ITN can stimulate degranulation of goblet cells in the conjunctiva, which is a promising new approach for the management of dry eye.
Authors: A A Afonso; L Sobrin; D C Monroy; M Selzer; B Lokeshwar; S C Pflugfelder Journal: Invest Ophthalmol Vis Sci Date: 1999-10 Impact factor: 4.799
Authors: Cintia S De Paiva; Arturo L Villarreal; Rosa M Corrales; Hassan T Rahman; Victor Y Chang; William J Farley; Michael E Stern; Jerry Y Niederkorn; De-Quan Li; Stephen C Pflugfelder Journal: Invest Ophthalmol Vis Sci Date: 2007-06 Impact factor: 4.799
Authors: Andrea L Kossler; Mark Brinton; Zara M Patel; Roopa Dalal; Christopher N Ta; Daniel Palanker Journal: Ocul Surf Date: 2019-08-30 Impact factor: 5.033
Authors: Gabriela M Dieckmann; Stephanie M Cox; Maria J Lopez; M Cuneyt Ozmen; Leyla Yavuz Saricay; Betul N Bayrakutar; William W Binotti; Eugenia Henry; Jeffrey Nau; Pedram Hamrah Journal: Ophthalmol Ther Date: 2022-06-02
Authors: David Wirta; Gail L Torkildsen; Blair Boehmer; David A Hollander; Edward Bendert; Lijuan Zeng; Michael Ackermann; Jeffrey Nau Journal: Cornea Date: 2021-12-21 Impact factor: 3.152
Authors: Alice T Epitropoulos; Sheraz M Daya; Cynthia Matossian; Alan G Kabat; Gretchen Blemker; Kristen Striffler; Laura Hendrix; Marian Macsai; Andrea Gibson Journal: Clin Ophthalmol Date: 2022-10-13
Authors: Marco H Ji; Darius M Moshfeghi; Laura Periman; David Kading; Cynthia Matossian; Gerald Walman; Scott Markham; Andy Mu; Ann Jayaram; Michael Gertner; Paul Karpecki; Neil J Friedman Journal: Transl Vis Sci Technol Date: 2020-11-17 Impact factor: 3.283