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

NCT01198782 | Completed Phase 4

• 1 other identifier: SMA-09-42
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dry Eye Syndrome

Outcome Measures

Primary Outcomes (1)

• The change from baseline in Total Corneal Staining.

  4 months

Study Arms (1)

FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops)

EXPERIMENTAL

SYSTANE® ULTRA Lubricant Eye Drops dosed 4 times daily

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

Interventions

FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops) OTHER

Patients will dose 4 times daily for 4 months.

FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Related Publications (1)

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

  RESULT

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 10, 2010
• Study Start: September 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: November 18, 2016

Record last verified: 2012-01