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

Alcon

Status and phase

Completed

Phase 4

Conditions

Dry Eye Syndrome

Treatments

Other: FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01198782

SMA-09-42

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of FID 112903 given as an immediate treatment replacement in dry eye subjects that discontinue at least 6 months use of RESTASIS.

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.