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

Oculeve, Inc.48 enrolled

Overview

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.

This is a prospective, randomized, controlled, double-masked, multicenter clinical trial in which participants with aqueous tear deficiency will receive three different device applications in a randomized sequence.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Dry Eye Syndrome Keratoconjunctivitis Sicca

Interventions

Oculeve IntranasalDEVICE

Oculeve device, intranasal (test) application for approximately 3 minutes.

ShamDEVICE

Sham device (control), intranasal application for approximately 3 minutes.

Oculeve ExtranasalDEVICE

Oculeve device, extranasal (control) application for approximately 3 minutes.

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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

Locations (2)

The Eye Care Group

Waterbury, Connecticut, United States

Virginia Eye Consultants

Norfolk, Virginia, United States

Outcomes

Primary Outcomes

Acute Stimulated Tear Production

Stimulated acute tear production in the study eye at Day 0 as measured by the difference between the Schirmer test score during stimulation and the test score before stimulation (basal). The Schirmer strip is placed just under the eyelid and wicks up the tears. It measures tear production on a linear scale of 0-35 mm. The study eye was defined as the eye with the greatest increase in tear production with stimulation by the cotton swab at Visit 1/Screening or, if there was no difference in stimulated tear production, the eye with the lower basal Schirmer score at Visit 2/Day 0 was selected. If there was no difference for either measure, the right eye was used as the study eye.

Time frame: Day 0 post-application

Percentage of Participants Who Experienced One or More Device-related Adverse Event (AE)

An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in participants, users or other persons it does not necessarily have to have a causal relationship with the investigational medical device. Device-related AEs were presented as ocular and non-ocular.

Time frame: Day 0

Data from ClinicalTrials.gov

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