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

Not Applicable

Terminated

• Conditions: Dry Eye Syndromes
• Interventions: Device: Intranasal Tear Neurostimulator (ITN) [TrueTear®]

• Registration Number: NCT03827564
• Lead Sponsor: Allergan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-31
• Study First Submitted QC: 2019-01-31
• Study First Posted: 2019-02-01
• Study Start: 2019-06-24
• Primary Completion: 2020-06-08
• Study Completion: 2020-06-08
• Results First Submitted: 2021-06-08
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-23
• Last Update Submitted: 2021-07-23
• Results First Posted: 2021-08-16
• Last Update Posted: 2021-08-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ITN [TrueTear®] - Intranasal Application	Intranasal Tear Neurostimulator (ITN) [TrueTear®]	Intranasal application of the ITN. Single application at application visit.
ITN [TrueTear®] - Extranasal Application	Intranasal Tear Neurostimulator (ITN) [TrueTear®]	Extranasal application of the ITN. Single application at application visit.

Primary Outcome Measures

Name	Time	Method
Difference in Ratio of Degranulated Goblet Cells.	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

Trial Locations

Locations (1)

Baylor College of Medicine - Department of Ophthalmology; 🇺🇸 Houston, Texas, United States