Safety and Efficacy of Two Artificial Tears in Dry Eye Subjects

Study Identifier
AG9965-002
CT.gov Identifier
NCT01010282
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
  • Glycerin and Polysorbate 80 based artificial tear
  • Formulation 1: Carboxymethylcellulose sodium, glycerin and Polysorbate 80, based artificial tear
  • Formulation 2: Carboxymethylcellulose sodium, glycerin, and Polysorbate 80 based artificial tear
    • Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Current use of an artificial tear at least twice daily, for at least three months prior to Day 1, on average * Ability/agreement to wear habitual correction (glasses) during study period
    Exclusion Criteria:
    * Known allergy or sensitivity to the study product(s) or its components * Anticipate contact lens wear during the study, or subject has worn contact lenses in the last six months * Chronic use of systemic medications which may affect a dry eye condition * Active ocular allergy or infection * Use of Restasis® or other topical cyclosporine products within 3 months prior to Day 1 * Current use of any topical ophthalmic medications, have used within 2 weeks prior to Day 1, or are likely to use during study.

    Protocol Summary

    This study will evaluate the safety, efficacy, and acceptability of two artificial tears compared to a currently available artificial tear in subjects with dry eye.

    Study Locations

    Location
    Status
    Location
    San Diego, California, United States
    Status
    Not applicable