N/A N=23 Randomized Double-blind Basic Science

Multicenter Trial Evaluating Quality of Tears Produced by Nasal Neurostimulation

Dry Eye Syndromes

Bottom Line

View on ClinicalTrials.gov: NCT02385292 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Oct 2021

Primary outcome: Primary: Fluorescein Tear Clearance With Application

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Oculeve Intranasal Lacrimal Neurostimulator (Device)
Age: Adult, Older Adult · 22+ yrs
Sex: All
Sponsor: Oculeve, Inc.
Primary completion: Mar 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Fluorescein Tear Clearance With Application	—	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02385292). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.