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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndrome
• Intervention / Treatment: Other: FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops)

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops); SYSTANE® ULTRA Lubricant Eye Drops dosed 4 times daily	Other: FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops); Patients will dose 4 times daily for 4 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The change from baseline in Total Corneal Staining.	4 months

Collaborators and Investigators

• Sponsor: Alcon Research

Publications and helpful links

General Publications

• http://iovs.arvojournals.org/article.aspx?articleid=2353102

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: September 9, 2010
• First Submitted That Met QC Criteria: September 9, 2010
• First Posted (Estimate): September 10, 2010

Study Record Updates

• Last Update Posted (Estimate): November 18, 2016
• Last Update Submitted That Met QC Criteria: November 17, 2016
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes; Pharmaceutical Solutions; Ophthalmic Solutions; Lubricant Eye Drops
• Other Study ID Numbers: SMA-09-42