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NCT03827564

Goblet Cell Degranulation Produced by Intranasal Tear Neurostimulator (ITN) in Dry Eye Disease

Terminated NA Results posted Last updated 16 August 2021
What this trial tests

NA trial testing Intranasal Tear Neurostimulator (ITN) [TrueTear®] in Dry Eye Syndromes in 14 participants. Terminated before completion.

Timeline
24 June 2019
Primary endpoint
8 June 2020
8 June 2020

Quick facts

Lead sponsorAllergan
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposebasic science
Enrollment14
Start date24 June 2019
Primary completion8 June 2020
Estimated completion8 June 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Allergan — full company profile →

Who can join

22 and older, any sex, with Dry Eye Syndromes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Difference in Ratio of Degranulated Goblet Cells. Primary · Screening (Day -60 to Day -30) to Application Visit (Day 0)

Mean change from Screening to Application Visit in ratio of goblet cell degranulation post-intranasal use of the Intranasal Tear Neurostimulator (ITN) at the Application visit compared to without use of the ITN at the Screening visit

GroupValue95% CI
ITN [TrueTear®] - Intranasal Application0.007± 0.171
ITN [TrueTear®] - Extranasal Application0.124± 0.069

Sponsor's own description

The purpose of this study is to evaluate goblet cell degranulation following acute use of the Intranasal Tear Neurostimulator in participants with dry eye.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Efficacy and safety of trigeminal parasympathetic pathway stimulation for dry eye: A systematic review and meta-analysis.
    Hu J, Ju M, Shi Y, Liu X, et al · · 2024 · cited 4× · PMID 38454841 · DOI 10.4103/ijo.ijo_2147_23

Verify or expand the search:

Other recruiting trials for Dry Eye Syndromes

Currently open trials in the same condition.

Other Allergan trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03827564.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing