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

Study Identifier
OCUN-007
CT.gov Identifier
NCT02313454
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:
    * 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

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Andover Eye Associates
    Andover, Massachusetts, United States, 01810
    Status
    Not applicable