Safety, Efficacy, Tolerability and Pharmacokinetics of AGN-223575 Ophthalmic Suspension in Patients With Dry Eye Disease

Study Identifier
223575-002
CT.gov Identifier
NCT02435914
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
  • AGN-223575 ophthalmic solution
  • AGN-223575 vehicle ophthalmic solution
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Signs and symptoms of dry eye disease * Has used RESTASIS and/or artificial tears in both eyes twice a day for at least 60 days.
    Exclusion Criteria:
    * History of glaucoma, or ocular hypertension * Diagnosis of ocular infection * Use of contact lenses in the past 14 days or expected use during the study * Use of any topical ophthalmic medications in the past 30 days * Use of corticosteroids in the past 30 days.

    Protocol Summary

    This study will evaluate the safety, efficacy, tolerability, and systemic pharmacokinetics of 3 different doses of topical ophthalmic AGN-223575 suspension compared to AGN-223575 vehicle in patients with dry eye disease.

    Study Locations

    Location
    Status
    Location
    Arizona Center for Clinical Trials
    Phoenix, Arizona, United States, 85003
    Status
    Not applicable
    Location
    Specialty Eye Ctr. Med. Group
    Glendale, California, United States, 91203
    Status
    Not applicable
    Location
    The Eye Research Foundation
    Newport Beach, California, United States, 92663
    Status
    Not applicable
    Location
    WCCT Global
    Santa Ana, California, United States, 92705
    Status
    Not applicable
    Location
    Eye Associates of Colorado Springs
    Colorado Springs, Colorado, United States, 80909
    Status
    Not applicable
    Location
    West Coast Eye Institute
    Lecanto, Florida, United States, 34491
    Status
    Not applicable
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