The purpose of this phase 3 study is to determine the safety and efficacy of cyclosporine in the treatment of dry eye syndrome.

Inclusion Criteria:

• Diagnosis of moderate to severe dry eye syndrome with or without Sjogren's syndrome or other autoimmune disease

Exclusion Criteria:

• Intraocular or refractive surgery in the study eye within 3 months prior to study start
• Unwilling to discontinue use of contact lenses during the run-in and duration of the study
• Pregnancy or lactation