Evaluating Safety and Efficacy of FID 112903 Post Discontinuation of Long-term Use of RESTASIS® (Cyclosporine Ophthalmic Emulsion) 0.05%
This study has been completed.
Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01198782
First received: September 9, 2010
Last updated: January 31, 2012
Last verified: January 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Dry Eye Syndrome |
Other: FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- The change from baseline in Total Corneal Staining. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
| Enrollment: | 48 |
| Study Start Date: | September 2010 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations
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More Information
No publications provided
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT01198782 History of Changes |
| Other Study ID Numbers: | SMA-09-42 |
| Study First Received: | September 9, 2010 |
| Last Updated: | January 31, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Dry Eye Syndromes Keratoconjunctivitis Sicca Lacrimal Apparatus Diseases Eye Diseases Keratoconjunctivitis Conjunctivitis Conjunctival Diseases Keratitis Corneal Diseases Tetrahydrozoline Cyclosporins Cyclosporine Nasal Decongestants Vasoconstrictor Agents Cardiovascular Agents |
Therapeutic Uses Pharmacologic Actions Respiratory System Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Antifungal Agents Anti-Infective Agents Dermatologic Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 22, 2013