A Natural History Study of Patients With Dry Eye

Study Identifier
MA-RES-08-001
CT.gov Identifier
NCT00833235
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
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    40+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Males at least 55 years old or females, at least 40 years old with perimenopausal symptoms * Baseline OSDI score of ≥ 13 * Patients with mild to moderate dry eye (dry eye disease patients only; not applicable for control group)
    Exclusion Criteria:
    * Use of any topical cyclosporine ophthalmic emulsion within 3 months of baseline * History of herpes keratitis or varicella zoster keratitis * Any history of allergic conjunctivitis * Temporary or permanent occlusion or cauterization of the lacrimal puncta for either eye * Any anterior segment surgery involving a limbal or corneal incision (cataract surgery), keratorefractive procedure (LASIK, LASEK, PRK) within 12 months of baseline, or expectation of such surgery within 2 years * Patients with known systemic disease * Any history of corneal transplant

    Protocol Summary

    This is a multi-center, prospective, controlled, observational study of the natural history of patients with dry eye disease.

    Study Locations

    Location
    Status
    Location
    Jones Eye Institute
    Little Rock, Arkansas, United States, 72205
    Status
    Not applicable
    Location
    North Valley Eye Medical Group, Inc.
    Mission Hills, California, United States, 91345
    Status
    Not applicable
    Location
    Milauskas Eye Institute
    Rancho Mirage, California, United States, 92270
    Status
    Not applicable
    Location
    Eye Center of Northern Colorado
    Fort Collins, Colorado, United States, 80525
    Status
    Not applicable
    Location
    Cape Coral Eye Center, PA
    Cape Coral, Florida, United States, 33904
    Status
    Not applicable
    Location
    The Eye Institute of West Florida
    Largo, Florida, United States, 33770
    Status
    Not applicable
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