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

Stopped early · Not applicable

Conditions studied: Dry Eye Syndromes

In brief

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

Key facts

Study ID

NCT03827564

Run by

Allergan

People needed

14

Starts

2019-06-24

Expected to finish

2020-06-08

Last updated by the study team

2021-08-16

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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