Safety and Efficacy of Carboxymethylcellulose for Ocular Surface Integrity in Symptomatic Dry Eye

Study Identifier
MAF-AGN-OPH-DE-011
CT.gov Identifier
NCT00987727
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
  • carboxymethylcellulose 0.5% , glycerin 0.9% (OPTIVE® MD)
  • sodium hyaluronate 0.18% (VISMED® Multi)
    • Phase
    Phase 4
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Have been using artificial tears for at least 3 months prior to study inclusion * Have been using preservative free artificial tears at least three times daily (TIB) for at least 2 weeks immediately prior to study inclusion * Having moderate to severe symptoms suggestive of dry eye
    Exclusion Criteria:
    * Current enrollment in an investigational drug or device study or participation in such a study within 3 months prior to entry into this study * Moderate to severe blepharitis * History or active signs of ocular trauma, ocular infection, or ocular inflammation within the last 3 months * History or active signs of ocular allergic disease or ocular herpes within the last year * History or active signs of severe or serious ocular conditions such as inflammatory corneal ulcers, recurrent erosions, and uveitis at any time.

    Protocol Summary

    This study will evaluate the safety and efficacy of OPTIVE® MD for ocular surface integrity in symptomatic dry eye condition in absence of obvious eye-lid inflammation.

    Study Locations

    Location
    Status
    Location
    Paris, France
    Status
    Not applicable