Study discontinued due to business reasons.

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

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

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/.

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.

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.

All 14 enrolled participants were randomized to study treatment.

Adverse data was collected from participants at Screening (Day -60 to Day -30) to the Application Visit (Day 0), with a 30-day safety follow-up after the application. A period of 60 to 90 days in total.

This study was terminated early, resulting in a small number of patients analyzed. Only a descriptive statistical analysis will be performed.