Evaluation of Dry Eye Symptoms in CAE With Application of Intranasal Neurostimulation

Multicenter, Randomized, Controlled, Single-Masked, Cross-Over Clinical Trial to Evaluate Dry Eye Symptoms With Application of the Oculeve Intranasal Tear Neurostimulator During Exposure to a Controlled Adverse Environment (CAE®)

This study evaluates the safety and effectiveness of the Intranasal Tear Neurostimulator applied intranasally (active) compared with the same device applied extranasally (control) relating to symptoms of dry eye exacerbated by the Controlled Adverse Environment model.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Device: Intranasal Tear Neurostimulator

Detailed Description

Participants will be randomized to a single application sequence, either sequence "A" (intranasal application followed by control application) or sequence "B" (control application followed by intranasal application) using the device. Upon entering the CAE, participants will complete dry eye questionnaires every five minutes and will administer the device either intranasally or extranasally in randomized sequence when a certain level of ocular discomfort has been reached.

• Study Type: Interventional
• Enrollment (Actual): 185
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • Eye Care Institute
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care, PA
    • Nashville, Tennessee, United States, 37205
      • Nashville Vision Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Moderate to severe dry eye disease
• Normal lid/lash anatomy, blinking function and closure as determined by the Investigator
• Literate, able to speak English, and able to complete questionnaires independently

Exclusion Criteria:

• Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the Investigator, may lead to risk of clinically significant increased bleeding
• Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas
• Implanted metallic or electronic device in the head, a cardiac demand pacemaker, or an implanted defibrillator
• Corneal transplant in either or both eyes
• A woman who is pregnant, nursing an infant, or planning a pregnancy at the Screening Visit
• Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to the Screening Visit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intranasal Application; Intranasal Tear Neurostimulator applied intranasally device (active), intranasal 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 the CAE exposure.	Device: Intranasal Tear Neurostimulator; The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.
SHAM_COMPARATOR: Extranasal Application; Intranasal Tear Neurostimulator device applied extranasally (control) 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 the CAE exposure.	Device: Intranasal Tear Neurostimulator; The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Pre-Application to Post-Application in Eye Dryness Score (EDS) 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. A cross-over linear model was used with symptom relief as the response variable; sequence, application location, period, and the application location by period interaction as fixed effects; and participant (sequence) as a random effect.	Pre-application to Post-application on Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 eye that reached the threshold triggering the first application or if both eyes reach the threshold at the same time, the eye with the higher discomfort score or if both eyes are the same, the right eye was used. A negative change from Baseline indicates improvement. A cross-over linear model was used with symptom relief as the response variable; sequence, application location, period, and the application location by period interaction as fixed effects; and participant (sequence) as a random effect.	Pre-application to Post-application on Day 0

Collaborators and Investigators

• Sponsor: Allergan

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 30, 2016
• Primary Completion (ACTUAL): October 31, 2016
• Study Completion (ACTUAL): October 31, 2016

Study Registration Dates

• First Submitted: September 20, 2016
• First Submitted That Met QC Criteria: September 20, 2016
• First Posted (ESTIMATE): September 22, 2016

Study Record Updates

• Last Update Posted (ACTUAL): January 31, 2020
• Last Update Submitted That Met QC Criteria: January 17, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: OCUN-011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes