Evaluation of the Safety and Effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator in Patients With Dry Eye

Allergan21 enrolled

Overview

The purpose of this study was to evaluate the safety and effectiveness of the Intranasal Tear Neurostimulator applied intranasally compared with the same device applied extranasally (control) in treating the symptoms of dry eye exacerbated by the Controlled Adverse Environment (CAE) Model.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Dry Eye Syndromes

Interventions

Intranasal Tear NeurostimulatorDEVICE

Neurostimulation applied intranasally and extranasally.

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Bilateral dry eyes * Capable of providing written informed consent Exclusion Criteria: * Chronic or recurring epistaxis (nosebleeds) * Uncontrolled systemic disease * Blood coagulation disorder * Females who are pregnant, nursing or planning a pregnancy

Locations (1)

Andover Eye Associates

Andover, Massachusetts, United States

Outcomes

Primary Outcomes

Change From Pre-Application to Post-Application in the Ora Calibra Ocular Discomfort Scale (ODS) Score

The participant graded their eye discomfort prior to CAE entry, during CAE exposure to threshold, then starting 1 minute after treatment application every 5 minutes in each eye separately using the Ora Calibra ODS where: 0=no discomfort to 4=constant discomfort. Data from the analysis eye was used to determine effectiveness. The analysis eye was defined as the first eye that reached the threshold and resulted in the device application. If both eyes reached the threshold at the same time point, the analysis eye was the eye with the lowest baseline Schirmer test score (a test to determine if the eye produces enough tears to keep it moist; \>10 mm is normal) or, if the Schirmer test scores were equal, the right eye. A negative change from Baseline indicates improvement.

Time frame: Pre-application to Post-application on Day 0

Secondary Outcomes

Change From Pre-Application to Post-Application in Dry Eye Symptoms (DES) Using a Visual Analog Scale (VAS)

The participant rated their eye dryness (both eyes simultaneously) at all visits and every 5 minutes during CAE exposure by placing a vertical mark on the 100 mm horizontal line to indicate the level of eye dryness. 0 corresponds to "no dryness" and 100 corresponds to "maximal dryness". A negative change from Baseline indicates improvement.

Time frame: Pre-application to Post-application on Day 0

Data from ClinicalTrials.gov

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