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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02910713
Recruitment Status : Completed
First Posted : September 22, 2016
Results First Posted : January 31, 2020
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
Allergan

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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Device: Intranasal Tear Neurostimulator Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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®)
Actual Study Start Date : September 30, 2016
Actual Primary Completion Date : October 31, 2016
Actual Study Completion Date : October 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

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.




Primary Outcome Measures :
  1. Change From Pre-Application to Post-Application in Eye Dryness Score (EDS) Using a Visual Analog Scale (VAS) [ Time Frame: Pre-application to Post-application on Day 0 ]
    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 :
  1. Change From Pre-Application to Post-Application in the Ora Calibra Ocular Discomfort Scale (ODS) Score [ Time Frame: Pre-application to Post-application on Day 0 ]
    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.



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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02910713


Locations
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United States, Kentucky
Eye Care Institute
Louisville, Kentucky, United States, 40206
United States, Tennessee
Total Eye Care, PA
Memphis, Tennessee, United States, 38119
Nashville Vision Associates
Nashville, Tennessee, United States, 37205
Sponsors and Collaborators
Allergan
Investigators
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Study Chair: Michelle Senchyna Allergan
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02910713    
Other Study ID Numbers: OCUN-011
First Posted: September 22, 2016    Key Record Dates
Results First Posted: January 31, 2020
Last Update Posted: January 31, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases