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

Allergan

Status

Terminated

Conditions

Dry Eye Syndromes

Treatments

Device: Intranasal Tear Neurostimulator (ITN) [TrueTear®]

Study type

Interventional

Funder types

Industry

Identifiers

NCT03827564

1919-802-019

Details and patient eligibility

About

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

Enrollment

14 patients

Sex

All

Ages

22+ years old

Volunteers

No 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