Evaluating Safety and Efficacy of FID 112903 Post Discontinuation of Long-term Use of RESTASIS® (Cyclosporine Ophthalmic Emulsion) 0.05%

Inclusion criteria

• Patients must be at least 18 years of age
• Patients must have a best corrected visual acuity of 0.6 LogMar or better in each eye, and must use Restasis BID for at least 6 months.
• Lastly, patients must have a sodium fluorescein (NaFl) corneal staining sum score of greater than or equal to 3 in the worse eye.

Exclusion criteria

• Patients cannot wear contact lenses during the study and cannot have a history of hypersensitivity to any component of FID 112903.
• Patients cannot have ocular or intraocular surgery or serious ocular trauma within the past 6 months, and cannot have punctal plugs of any type.
• Patients cannot use any prescription topical medication for other ocular conditions (such as glaucoma, uveitis, etc).
• Patients cannot use systemic medications that may contribute to dry eye if the dosing regimen has not been stable for at least 30 days prior to Visit 1.
• Patients cannot have ocular conditions that, in the opinion of the investigator, preclude the safe administration of the test article.
• Patients cannot have a history and/or current evidence of the following: epithelial herpes simplex keratitis (dendritic keratitis); vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva; active ocular rosacea; acute or chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal diseases of the eye.