Safety and Efficacy Study of New Eye Drop Formulations With Refresh Tears® in Patients With Dry Eye Disease

Study Identifier
10078X-001
CT.gov Identifier
NCT01294384
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 sodium based New Eye Drop Formulation 1
  • carboxymethylcellulose sodium based New Eye Drop Formulation 2
  • carboxymethylcellulose sodium based Eye Drops
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Current use of an artificial tear product at least twice daily for at least 3 months, on average * Ability/agreement to continue wearing existing spectacle correction (glasses) during study
    Exclusion Criteria:
    * Anticipated contact lens wear during study or contact lens use within 6 months * Active ocular infection or allergy * Use of any topical ophthalmic medications (eg, topical ophthalmic steroids, glaucoma drops) within 2 weeks * Use of any topical cyclosporine products within 3 months

    Protocol Summary

    This study will investigate the safety, efficacy and acceptability of two new eye drop formulations compared with Refresh Tears® in patients with dry eye disease.

    Study Locations

    Location
    Status
    Location
    Randwick, New South Wales, Australia
    Status
    Not applicable
    Location
    St. John's, Newfoundland and Labrador, Canada
    Status
    Not applicable