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

Primary Purpose

Dry Eye Syndromes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intranasal Tear Neurostimulator
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes focused on measuring dry eye syndrome, keratoconjunctivitis, ophthalmic, eye disease, corneal disease, keratitis

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Andover Eye Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Intranasal Application

Extranasal Application

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 8, 2014
Last Updated
January 17, 2020
Sponsor
Allergan
Collaborators
ORA, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02313454
Brief Title
Evaluation of the Safety and Effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator in Patients With Dry Eye
Official Title
A Single Center, Randomized, Controlled, Single-Masked, Cross-Over Clinical Pilot Study to Evaluate the Reduction in the Exacerbation of the Symptoms of Dry Eye Upon Exposure to a Controlled Adverse Environment (CAESM) With Treatment by the Oculeve Nasal Lacrimal TENS Unit
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 17, 2014 (Actual)
Primary Completion Date
April 8, 2015 (Actual)
Study Completion Date
April 8, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
Collaborators
ORA, Inc.

4. Oversight

Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
Keywords
dry eye syndrome, keratoconjunctivitis, ophthalmic, eye disease, corneal disease, keratitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intranasal Application
Arm Type
Experimental
Arm 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.
Arm Title
Extranasal Application
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Intranasal Tear Neurostimulator
Intervention Description
Neurostimulation applied intranasally and extranasally.
Primary Outcome Measure Information:
Title
Change From Pre-Application to Post-Application in the Ora Calibra Ocular Discomfort Scale (ODS) Score
Description
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 Outcome Measure Information:
Title
Change From Pre-Application to Post-Application in Dry Eye Symptoms (DES) Using a Visual Analog Scale (VAS)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Senchyna
Organizational Affiliation
Allergan
Official's Role
Study Chair
Facility Information:
Facility Name
Andover Eye Associates
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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