N/A N=48 Randomized Single-blind Supportive Care

A Study to Evaluate the Safety and Effectiveness of Oculeve Intranasal Lacrimal Neurostimulator in Participants With Dry Eye Syndrome

Dry Eye Syndrome · Keratoconjunctivitis Sicca

Bottom Line

View on ClinicalTrials.gov: NCT02680158 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2019

Primary outcome: Primary: Acute Stimulated Tear Production — 25.3; 9.2; 9.5 mm

Study Design & Population

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Acute Stimulated Tear Production	25.3; 9.2; 9.5	—
PRIMARY Percentage of Participants Who Experienced One or More Device-related Adverse Event (AE)	0; 0; 0; 4.2; 0; 0	—

Summary

The purpose of this study is to compare acute tear production produced by the Oculeve Intranasal Lacrimal Neurostimulator with two control devices in participants with aqueous tear deficiency.

Eligibility Criteria

Inclusion Criteria

Participants with aqueous tear deficiency
Literate, able to speak English or Spanish, and able to complete questionnaires independently
Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol

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 nasal cautery or significant trauma
Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device
Diagnosis of epilepsy
Corneal transplant in either or both eyes
Participation in any clinical trial with a new active substance or a new device within 30 days of the Screening Visit
A woman who is pregnant, planning a pregnancy, or nursing at the Screening Visit

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02680158). 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.