Safety and Efficacy of TrueTear™ for the Treatment of Meibomian Gland Disease

Study Identifier
OCUN-023
CT.gov Identifier
NCT03226769
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Statistical Analysis Plan
Available Language(s): English
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Protocol
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
    22+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Dry eye disease or Meibomian Gland Disease as evaluated by Standard Participant Evaluation for Dryness (SPEED) score, Schirmer test, Tear film breakup time and other applicable objective measures at the Screening and Baseline Visits. * Use of an artificial tear product, lid hygiene, omega-3 supplementation, antibiotics for the treatment of dry eye disease or Meibomian Gland Disease within one year of the Screening Visit.
    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 compare the safety and efficacy of TrueTear™ to standardized moist heat compress (Thermalon® Dry Eye Compress) for the treatment of Meibomian Gland Disease (MGD).

    Study Locations

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