A Prospective, Randomized, Placebo and Active Comparator Controlled Study of CP-690,550 in Subjects With Dry Eye.
NCT ID: NCT00784719
Last Updated: 2013-04-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
327 participants
INTERVENTIONAL
2008-11-30
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment 1
CP-690,550
Ophthalmic topical solution, low dose, dosed at least once/day, 8 weeks
Treatment 2
CP-690,550
Ophthalmic topical solution, medium dose, dosed at least once/day, 8 weeks
Treatment 3
CP-690,550
Ophthalmic topical solution, intermediate dose, dosed at least once/day, 8 weeks
Treatment 4
CP-690,550
Ophthalmic topical solution, high dose, dosed at least once/day, 8 weeks
Active comparator
Cyclosporine
Ophthalmic topical solution, 0.05%, dosed at least once/day, 8 weeks
Placebo
CP-690,550 Vehicle
Ophthalmic topical solution, dosed at least once/day, 8 weeks
Interventions
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CP-690,550
Ophthalmic topical solution, low dose, dosed at least once/day, 8 weeks
CP-690,550
Ophthalmic topical solution, medium dose, dosed at least once/day, 8 weeks
CP-690,550
Ophthalmic topical solution, intermediate dose, dosed at least once/day, 8 weeks
CP-690,550
Ophthalmic topical solution, high dose, dosed at least once/day, 8 weeks
Cyclosporine
Ophthalmic topical solution, 0.05%, dosed at least once/day, 8 weeks
CP-690,550 Vehicle
Ophthalmic topical solution, dosed at least once/day, 8 weeks
Eligibility Criteria
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Inclusion Criteria
* Signs of moderate to severe dry eye
Exclusion Criteria
* Participation in other studies within 30 days of screening visit
* Ocular disorders that may confound interpretation of study results
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Chandler, Arizona, United States
Pfizer Investigational Site
Peoria, Arizona, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Artesia, California, United States
Pfizer Investigational Site
Centennial, Colorado, United States
Pfizer Investigational Site
Ormond Beach, Florida, United States
Pfizer Investigational Site
Stuart, Florida, United States
Pfizer Investigational Site
Tamarac, Florida, United States
Pfizer Investigational Site
Tampa, Florida, United States
Pfizer Investigational Site
Atlanta, Georgia, United States
Pfizer Investigational Site
Morrow, Georgia, United States
Pfizer Investigational Site
Roswell, Georgia, United States
Pfizer Investigational Site
Louisville, Kentucky, United States
Pfizer Investigational Site
Baltimore, Maryland, United States
Pfizer Investigational Site
Boston, Massachusetts, United States
Pfizer Investigational Site
Kansas City, Missouri, United States
Pfizer Investigational Site
Lynbrook, New York, United States
Pfizer Investigational Site
Rochester, New York, United States
Pfizer Investigational Site
Charlotte, North Carolina, United States
Pfizer Investigational Site
High Point, North Carolina, United States
Pfizer Investigational Site
Cleveland, Ohio, United States
Pfizer Investigational Site
Columbus, Ohio, United States
Pfizer Investigational Site
Memphis, Tennessee, United States
Pfizer Investigational Site
Austin, Texas, United States
Pfizer Investigational Site
Austin, Texas, United States
Pfizer Investigational Site
Austin, Texas, United States
Pfizer Investigational Site
San Antonio, Texas, United States
Countries
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References
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Liew MS, Zhang M, Kim E, Akpek EK. Prevalence and predictors of Sjogren's syndrome in a prospective cohort of patients with aqueous-deficient dry eye. Br J Ophthalmol. 2012 Dec;96(12):1498-503. doi: 10.1136/bjophthalmol-2012-301767. Epub 2012 Sep 21.
Huang JF, Yafawi R, Zhang M, McDowell M, Rittenhouse KD, Sace F, Liew SH, Cooper SR, Pickering EH. Immunomodulatory effect of the topical ophthalmic Janus kinase inhibitor tofacitinib (CP-690,550) in patients with dry eye disease. Ophthalmology. 2012 Jul;119(7):e43-50. doi: 10.1016/j.ophtha.2012.03.017. Epub 2012 May 18.
Liew SH, Nichols KK, Klamerus KJ, Li JZ, Zhang M, Foulks GN. Tofacitinib (CP-690,550), a Janus kinase inhibitor for dry eye disease: results from a phase 1/2 trial. Ophthalmology. 2012 Jul;119(7):1328-35. doi: 10.1016/j.ophtha.2012.01.028. Epub 2012 Apr 22.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A3921034
Identifier Type: -
Identifier Source: secondary_id
A3921034
Identifier Type: -
Identifier Source: org_study_id
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