Safety, Tolerability and Systemic Pharmacokinetics of AGN-232411 in Healthy Participants and Participants With Dry Eye

Study Identifier
232411-001
CT.gov Identifier
NCT02420730
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
  • Healthy Volunteer
  • Dry Eye
    • Study Drug
  • AGN-232411
  • AGN-232411 Vehicle
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    Stage 1 -Healthy participants. Stage 2 -Participants with the symptoms of dry eye disease.
    Exclusion Criteria:
    Stage 1 -Known allergies or sensitivities to study medications, fluorescein, or lissamine green Stage 2 * Known allergies or sensitivities to study medications, fluorescein, or lissamine green * Allergic ocular disease, ocular trauma, corneal erosions or ulcers, or uveitis within the previous 12 months * History of any ocular surgery within the previous 12 months.

    Protocol Summary

    This study will examine the safety, tolerability, and systemic pharmacokinetics of up to 3 different concentrations of AGN-232411 topical ophthalmic solution in healthy participants and participants with dry eye.

    Study Locations

    Location
    Status
    Location
    Sall Research Center
    Artesia, California, United States, 90701
    Status
    Not applicable
    Location
    Lugene Eye Institute
    Glendale, California, United States, 91204
    Status
    Not applicable
    Location
    Montebello Medical Center, Inc.
    Montebello, California, United States, 90640
    Status
    Not applicable