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

Goblet Cell Degranulation Produced by Nasal Neurostimulation: A Randomized, Controlled Study in Patients With Dry Eye Disease

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

Study Overview

• Status: Terminated
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Device: Intranasal Tear Neurostimulator (ITN) [TrueTear®]

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030-3411
      • Baylor College of Medicine - Department of Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Capable of giving verbal and signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
• Have not worn contact lenses for at least 7 days prior to the screening visit and are willing to forego the use of contact lenses for the duration of the study
• The participant should be literate, able to speak English, and able to complete questionnaires independently

Exclusion Criteria:

• Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to clinically significant increased bleeding
• Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas
• Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device
• Corneal transplant in either or both eyes
• Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
• Women who are pregnant, planning a pregnancy, or nursing throughout the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ITN [TrueTear®] - Intranasal Application; Intranasal application of the ITN. Single application at application visit.	Device: Intranasal Tear Neurostimulator (ITN) [TrueTear®]; The ITN applies a small electrical current to the nasal cavities to gently activate the body's natural tear production system.
EXPERIMENTAL: ITN [TrueTear®] - Extranasal Application; Extranasal application of the ITN. Single application at application visit.	Device: Intranasal Tear Neurostimulator (ITN) [TrueTear®]; The ITN applies a small electrical current to the nasal cavities to gently activate the body's natural tear production system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Ratio of Degranulated Goblet Cells.	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	Screening (Day -60 to Day -30) to Application Visit (Day 0)

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Principal Investigator: Stephen Pflugfelder, MD, Baylor College of Medicine, Department of Ophthalmology

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 24, 2019
• Primary Completion (ACTUAL): June 8, 2020
• Study Completion (ACTUAL): June 8, 2020

Study Registration Dates

• First Submitted: January 31, 2019
• First Submitted That Met QC Criteria: January 31, 2019
• First Posted (ACTUAL): February 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 16, 2021
• Last Update Submitted That Met QC Criteria: July 23, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Dry Eye Disease
• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: 1919-802-019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.
• IPD Sharing Time Frame: After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
• IPD Sharing Access Criteria: To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No