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

Primary Purpose

Dry Eye Syndromes

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intranasal Tear Neurostimulator (ITN) [TrueTear®]
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Dry Eye Syndromes focused on measuring Dry Eye Disease

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baylor College of Medicine - Department of Ophthalmology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ITN [TrueTear®] - Intranasal Application

ITN [TrueTear®] - Extranasal Application

Arm Description

Intranasal application of the ITN. Single application at application visit.

Extranasal application of the ITN. Single application at application visit.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 31, 2019
Last Updated
July 23, 2021
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT03827564
Brief Title
Goblet Cell Degranulation Produced by Intranasal Tear Neurostimulator (ITN) in Dry Eye Disease
Official Title
Goblet Cell Degranulation Produced by Nasal Neurostimulation: A Randomized, Controlled Study in Patients With Dry Eye Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
Study discontinued due to business reasons.
Study Start Date
June 24, 2019 (Actual)
Primary Completion Date
June 8, 2020 (Actual)
Study Completion Date
June 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
Keywords
Dry Eye Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ITN [TrueTear®] - Intranasal Application
Arm Type
Experimental
Arm Description
Intranasal application of the ITN. Single application at application visit.
Arm Title
ITN [TrueTear®] - Extranasal Application
Arm Type
Experimental
Arm Description
Extranasal application of the ITN. Single application at application visit.
Intervention Type
Device
Intervention Name(s)
Intranasal Tear Neurostimulator (ITN) [TrueTear®]
Intervention Description
The ITN applies a small electrical current to the nasal cavities to gently activate the body's natural tear production system.
Primary Outcome Measure Information:
Title
Difference in Ratio of Degranulated Goblet Cells.
Description
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
Time Frame
Screening (Day -60 to Day -30) to Application Visit (Day 0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Pflugfelder, MD
Organizational Affiliation
Baylor College of Medicine, Department of Ophthalmology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor College of Medicine - Department of Ophthalmology
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-3411
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://www.allerganclinicaltrials.com/

Learn more about this trial

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

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