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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01198782
Recruitment Status : Completed
First Posted : September 10, 2010
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndrome Other: FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Systane

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.




Primary Outcome Measures :
  1. The change from baseline in Total Corneal Staining. [ Time Frame: 4 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Publications of Results:
http://iovs.arvojournals.org/article.aspx?articleid=2353102

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01198782    
Other Study ID Numbers: SMA-09-42
First Posted: September 10, 2010    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: January 2012
Additional relevant MeSH terms:
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Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Ophthalmic Solutions
Lubricant Eye Drops
Pharmaceutical Solutions