Study of Two Formulations of Cyclosporine Ophthalmic Emulsion in Healthy Volunteers and in Patients With Dry Eye

Study Identifier
192371-021
CT.gov Identifier
NCT01319773
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
  • cyclosporine ophthalmic emulsion Formulation A
  • cyclosporine ophthalmic emulsion Formulation B
  • cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion 0.05%
  • cyclosporine ophthalmic emulsion Formulation B; cyclosporine ophthalmic emulsion 0.05%
  • cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion Formulation B
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    Parallel-Group Phase: * Weigh at least 110 lbs * 18 to 45 years old Paired-Eye Phase: * Dry eye disease in both eyes
    Exclusion Criteria:
    Parallel-Group Phase: * Use of nicotine products, any medications, supplements or herbal products or consumption of grapefruit juice within 14 days or anticipated use during the study * Has donated blood within 90 days * Significant weight change (over 10 lbs) within 60 days * Previous use of RESTASIS® Parallel-Group and Paired-Eye Phases: * Anticipated wearing of contact lenses during the study or wearing of contact lenses within 14 days * Consumption of alcohol products within 72 hours Paired-Eye Phase: * Previous ocular surgery * Use of RESTASIS® within 30 days

    Protocol Summary

    This study will evaluate the safety, tolerability and pharmacokinetics of two formulations of cyclosporine ophthalmic emulsion in healthy adults (parallel-group phase). The parallel-group phase will be followed by a paired-eye phase which will evaluate the safety and tolerability of two formulations of cyclosporine ophthalmic emulsion compared with cyclosporine ophthalmic emulsion (RESTASIS®) in patients with dry eye.

    Study Locations

    Location
    Status
    Location
    Newport Beach, California, United States
    Status
    Not applicable