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

Not Applicable

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Device: Intranasal Tear Neurostimulator

• Registration Number: NCT02313454
• Lead Sponsor: Allergan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-17
• Study First Submitted: 2014-12-08
• Study First Submitted QC: 2014-12-08
• Study First Posted: 2014-12-10
• Primary Completion: 2015-04-08
• Study Completion: 2015-04-08
• Results First Submitted: 2019-11-27
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-17
• Last Update Submitted: 2020-01-17
• Results First Posted: 2020-01-31
• Last Update Posted: 2020-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intranasal Application	Intranasal Tear Neurostimulator	Intranasal Tear Neurostimulator device, intranasal application for approximately 3 minutes on Day 0 when the participant experienced an Ocular Discomfort Score (ODS) ≥3 at 2 or more consecutive time points in at least one eye during CAE exposure.
Extranasal Application	Intranasal Tear Neurostimulator	Intranasal Tear Neurostimulator device, extranasal application for approximately 3 minutes on Day 0 when the participant experienced an ODS ≥3 at 2 or more consecutive time points in at least one eye during CAE exposure.

Primary Outcome Measures

Name	Time	Method
Change From Pre-Application to Post-Application in the Ora Calibra Ocular Discomfort Scale (ODS) Score	Pre-application to Post-application on Day 0	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.

Secondary Outcome Measures

Name	Time	Method
Change From Pre-Application to Post-Application in Dry Eye Symptoms (DES) Using a Visual Analog Scale (VAS)	Pre-application to Post-application on Day 0	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.

Trial Locations

Locations (1)

Andover Eye Associates; 🇺🇸 Andover, Massachusetts, United States