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

Allergan

Status: Completed

Conditions: Dry Eye Syndromes

Treatments: Device: Intranasal Tear Neurostimulator

Study type: Interventional

Funder types: Industry

Identifiers

NCT02313454

OCUN-007

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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21 participants in 2 patient groups

Intranasal Application

Experimental group

Description:

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.

Treatment:

Device: Intranasal Tear Neurostimulator

Extranasal Application

Sham Comparator group

Description:

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.

Treatment:

Device: Intranasal Tear Neurostimulator