Clinical Study to Evaluate Tear Characteristics Following Acute TrueTear™ Use

Study Identifier
OCUN-020
CT.gov Identifier
NCT03274999
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

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Results Available

Protocol and Statistical Analysis Plan
Available Language(s): English
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Study Details

Medical Condition
  • Dry Eye
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Baseline Ocular Surface Disease Index© (OSDI©) score of at least 23 with no more than three responses of "not applicable" * In at least one eye, a baseline Schirmer test of ≤ 10 mm/5 minutes AND a cotton swab nasal stimulation Schirmer test of at least 7 mm higher in the same eye
    Exclusion Criteria:
    * Chronic or recurrent epistaxis, coagulation disorders or other conditions that may increase the risk of bleeding * History of nasal or sinus surgery * Vascularized polyp, deviated septum or severe nasal airway obstruction at the Screening visit * Intraocular and extraocular surgery in either eye within three months of the Screening Visit or refractive surgery within twelve months of the Screening Visit * Cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or active implanted electronic device in the head

    Protocol Summary

    This study will evaluate the change in tear meniscus height (TMH) produced by intranasal stimulation with TrueTear™ compared with the same device applied extranasally (control).

    Study Locations

    Location
    Status
    Location
    Ocular Technology Group International
    London, United Kingdom, SW1E 6AU
    Status
    Not applicable