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

Phase 4

Completed

• Conditions: Dry Eye Syndrome
• Interventions: Other: FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops)

• Registration Number: NCT01198782
• Lead Sponsor: Alcon Research

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-09
• Study First Submitted QC: 2010-09-09
• Study First Posted: 2010-09-10
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2012-01
• Last Update Submitted: 2016-11-17
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops)	FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops)	SYSTANE® ULTRA Lubricant Eye Drops dosed 4 times daily

Primary Outcome Measures

Name	Time	Method
The change from baseline in Total Corneal Staining.	4 months