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

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.

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