PMID- 30472141
OWN - NLM
STAT- MEDLINE
DCOM- 20200601
LR  - 20200601
IS  - 1937-5913 (Electronic)
IS  - 1542-0124 (Linking)
VI  - 17
IP  - 1
DP  - 2019 Jan
TI  - Characterization of tear production in subjects with dry eye disease during 
      intranasal tear neurostimulation: Results from two pivotal clinical trials.
PG  - 142-150
LID - S1542-0124(18)30271-4 [pii]
LID - 10.1016/j.jtos.2018.11.009 [doi]
AB  - PURPOSE: The intranasal tear neurostimulator (ITN) activates the nasolacrimal 
      pathway, which is involved with basal and bolus tear secretion. These studies 
      characterized the acute and long-term effectiveness of the ITN in stimulating 
      tear production in subjects with dry eye disease (DED). METHODS: Study 1: 
      Randomized, double-masked, dual-controlled, 1-day crossover. Study 2: Single-arm, 
      open-label, 180-day prospective cohort. Eligible subjects had basal unstimulated 
      Schirmer test (with anesthesia) </=10 mm and intranasal cotton swab-stimulated 
      Schirmer test at least 7 mm greater in the same eye, and Ocular Surface Disease 
      Index((R)) >/=13 and >/= 23, in Studies 1 and 2, respectively. Study 1: Subjects 
      (n = 48) received three randomized test applications: active intranasal, 
      extranasal (active control), and sham intranasal (inactive control) stimulation, 
      3 min/application with 1-hour minimum between applications. Primary outcome 
      measure was the difference in Schirmer test scores during active intranasal and 
      control applications. Study 2: Subjects (n = 97) performed intranasal 
      neurostimulation for </=3 min/application, 2-10 times/day. Primary outcome measure 
      was the difference in Schirmer scores (stimulated minus unstimulated) at day 180. 
      Both studies recorded device-related adverse events (AEs). RESULTS: Study 1: 
      Schirmer scores (mean +/- SEM) were significantly greater (p < 0.0001) with active 
      intranasal (25.3 +/- 1.5 mm) vs extranasal (9.5 +/- 1.2 mm) and sham (9.2 +/- 1.1 mm) 
      applications. Study 2: Schirmer scores were significantly greater (p < 0.0001) 
      with ITN stimulation vs unstimulated at day 180 (17.3 +/- 1.3 mm vs 7.9 +/- 0.7 mm). 
      No serious device-related AEs were reported in either study. CONCLUSION: The ITN 
      was well-tolerated and effective in stimulating tear production with acute and 
      long-term use in DED. CLINICALTRIALS. GOV IDENTIFIER: NCT02680158 and 
      NCT02526290.
CI  - Copyright (c) 2018 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Sheppard, John D
AU  - Sheppard JD
AD  - Virginia Eye Consultants and Eastern Virginia Medical School, Norfolk, VA, USA. 
      Electronic address: docshep@hotmail.com.
FAU - Torkildsen, Gail L
AU  - Torkildsen GL
AD  - Andover Eye Associates, Andover, MA, USA.
FAU - Geffin, Joel A
AU  - Geffin JA
AD  - The Eye Care Group, Waterbury, CT, USA.
FAU - Dao, Jung
AU  - Dao J
AD  - Cornea and Cataract Consultants of Arizona, Phoenix, AZ, USA.
FAU - Evans, David G
AU  - Evans DG
AD  - Total Eye Care, Memphis, TN, USA.
FAU - Ousler, George W
AU  - Ousler GW
AD  - Ora, Inc., Andover, MA, USA.
FAU - Wilson, Jasmine
AU  - Wilson J
AD  - Allergan plc, South San Francisco, CA, USA.
FAU - Baba, Stephanie N
AU  - Baba SN
AD  - Allergan plc, South San Francisco, CA, USA.
FAU - Senchyna, Michelle
AU  - Senchyna M
AD  - Allergan plc, Irvine, CA, USA.
FAU - Holland, Edward J
AU  - Holland EJ
AD  - Cincinnati Eye Institute and the University of Cincinnati, Cincinnati, OH, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT02680158
SI  - ClinicalTrials.gov/NCT02526290
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20181122
PL  - United States
TA  - Ocul Surf
JT  - The ocular surface
JID - 101156063
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Cross-Over Studies
MH  - Double-Blind Method
MH  - Dry Eye Syndromes/metabolism/*therapy
MH  - Electric Stimulation Therapy/*instrumentation
MH  - Equipment Design
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Lacrimal Apparatus/innervation/*metabolism
MH  - Male
MH  - Middle Aged
MH  - Nasal Mucosa/*innervation
MH  - Prospective Studies
MH  - Tears/*metabolism
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Dry eye disease
OT  - Intranasal neurostimulation
OT  - Tear production
EDAT- 2018/11/26 06:00
MHDA- 2020/06/02 06:00
CRDT- 2018/11/26 06:00
PHST- 2018/09/06 00:00 [received]
PHST- 2018/11/13 00:00 [revised]
PHST- 2018/11/21 00:00 [accepted]
PHST- 2018/11/26 06:00 [pubmed]
PHST- 2020/06/02 06:00 [medline]
PHST- 2018/11/26 06:00 [entrez]
AID - S1542-0124(18)30271-4 [pii]
AID - 10.1016/j.jtos.2018.11.009 [doi]
PST - ppublish
SO  - Ocul Surf. 2019 Jan;17(1):142-150. doi: 10.1016/j.jtos.2018.11.009. Epub 2018 Nov 
      22.