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

Dry Eye Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03827564
• Other study ID #: 1919-802-019
• Status: Terminated
• Phase: N/A
• Start date: June 24, 2019
• Est. completion date: June 8, 2020

Study information

• Verified date: July 2021
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: June 8, 2020
• Est. primary completion date: June 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

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.

Locations

Country	Name	City	State
United States	Baylor College of Medicine - Department of Ophthalmology	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)