Study of Two Formulations of Cyclosporine Ophthalmic Emulsion in Healthy Volunteers and in Patients With Dry Eye
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: 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
Intervention description: One drop of cyclosporine ophthalmic emulsion Formulation A administered to each eye twice daily for 2 days and once in the morning of Day 3.; One drop of cyclosporine ophthalmic emulsion Formulation B administered to each eye twice daily for 2 days and once in the morning of Day 3.; One drop of cyclosporine ophthalmic emulsion Formulation A administered to one eye and one drop of cyclosporine ophthalmic emulsion 0.05% administered to the opposite eye, twice daily for 1 day.; One drop of cyclosporine ophthalmic emulsion Formulation B administered to one eye and one drop of cyclosporine ophthalmic emulsion 0.05% administered to the opposite eye, twice daily for 1 day.; One drop of cyclosporine ophthalmic emulsion Formulation A administered to one eye and one drop of cyclosporine ophthalmic emulsion Formulation B administered to the opposite eye, twice daily for 1 day.
Intervention MeSH terms: Cyclosporine; Cyclosporins
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility 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