Multicenter Trial Evaluating Quality of Tears Produced by Nasal Neurostimulation

Randomized, Controlled, Crossover, Multicenter Trial Comparing Quality of Tears Produced by Nasal Neurostimulation Versus Sham for Dry Eye

The objectives of this study are:

• To compare the change in levels of tear proteins and inflammatory mediators pre and post administration between the intranasal and extranasal applications
• To compare the goblet cell count following application between the intranasal and extranasal applications
• To compare fluorescein tear clearance with the application of the device intranasally and extranasally applications

In this study, subjects will participate for three study days during up to a 44 day period, consisting of a screening examination to determine eligibility on one day and study applications on two different days. There are two applications, intranasal and extranasal. Subjects will receive both applications, in random sequence, one at each of the two application days (Visit 2 and Visit 3). The two applications consist of:

• Active intranasal device application
• Active extranasal device application

Inclusion Criteria:

• Bilateral dry eyes
• Capable of providing written informed consent

Exclusion Criteria:

• Chronic or recurring epistaxis (nosebleeds)
• Blood coagulation disorder
• Uncontrolled or poorly controlled diabetes
• Heart or pulmonary disease
• Females who are pregnant, planning a pregnancy or nursing