Back to resultsEvaluation of Dry Eye Symptoms in CAE With Application of Intranasal Neurostimulation
Primary Purpose
Dry Eye Syndromes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intranasal Tear Neurostimulator
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndromes
Eligibility Criteria
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
Sites / Locations
- Eye Care Institute
- Total Eye Care, PA
- Nashville Vision 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 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary 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 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02910713
Brief Title
Evaluation of Dry Eye Symptoms in CAE With Application of Intranasal Neurostimulation
Official Title
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®)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 30, 2016 (Actual)
Primary Completion Date
October 31, 2016 (Actual)
Study Completion Date
October 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
185 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intranasal Application
Arm Type
Experimental
Arm Description
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.
Arm Title
Extranasal Application
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Intranasal Tear Neurostimulator
Intervention Description
The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.
Primary Outcome Measure Information:
Title
Change From Pre-Application to Post-Application in Eye Dryness Score (EDS) 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. 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.
Time Frame
Pre-application to Post-application on Day 0
Secondary 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 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.
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Senchyna
Organizational Affiliation
Allergan
Official's Role
Study Chair
Facility Information:
Facility Name
Eye Care Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Total Eye Care, PA
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Nashville Vision Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Dry Eye Symptoms in CAE With Application of Intranasal Neurostimulation
We'll reach out to this number within 24 hrs