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

Study Identifier
OCUN-011
CT.gov Identifier
NCT02910713
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Dry Eye
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    22+ years
    Inclusion and Exclusion 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

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Eye Care Institute
    Louisville, Kentucky, United States, 40206
    Status
    Not applicable
    Location
    Total Eye Care, PA
    Memphis, Tennessee, United States, 38119
    Status
    Not applicable
    Location
    Nashville Vision Associates
    Nashville, Tennessee, United States, 37205
    Status
    Not applicable