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

NCT02313454 | Completed Results FDA Device

• 1 other identifier: OCUN-007
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Syndromes

Keywords

dry eye syndrome; keratoconjunctivitis; ophthalmic; eye disease; corneal disease; keratitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Pre-application to Post-application on Day 0

Secondary Outcomes (1)

• 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

Study Arms (2)

Intranasal Application

EXPERIMENTAL

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.

Device: Intranasal Tear Neurostimulator

Extranasal Application

SHAM COMPARATOR

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.

Device: Intranasal Tear Neurostimulator

Interventions

Intranasal Tear Neurostimulator DEVICE

Neurostimulation applied intranasally and extranasally.

Extranasal Application; Intranasal Application

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Bilateral dry eyes
• Capable of providing written informed consent

You may not qualify if:

• Chronic or recurring epistaxis (nosebleeds)
• Uncontrolled systemic disease
• Blood coagulation disorder
• Females who are pregnant, nursing or planning a pregnancy

Sponsors & Collaborators

• Allergan: lead
• ORA, Inc.: collaborator

Study Sites (1)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Keratoconjunctivitis; Eye Diseases; Corneal Diseases; Keratitis

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Conjunctivitis; Conjunctival Diseases

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Michelle Senchyna

  Allergan

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 10, 2014
• Study Start: November 17, 2014
• Primary Completion: April 8, 2015
• Study Completion: April 8, 2015
• Last Updated: January 31, 2020
• Results First Posted: January 31, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)