April 2011
Volume 52, Issue 14
ARVO Annual Meeting Abstract  |   April 2011
Safety and Efficacy of Topical Ophthalmic CP-690,550, a Janus Kinase Inhibitor, for Dry Eye Disease: A Phase 1/2 Clinical Trial
Author Affiliations & Notes
  • Shiao Hui M. Liew
    Pfizer Inc., San Diego, California
  • Kelly K. Nichols
    College of Optometry, Ohio State Univ, Columbus, Ohio
  • Karen Klamerus
    Clinical Pharmacology, Pfizer, San Diego, California
  • Jim Z. Li
    Clinical Development & Medical Affairs, Pfizer Inc, San Diego, California
  • Min Zhang
    Pfizer Inc., New York, New York
  • Gary N. Foulks
    Department of Ophthalmology, University of Louisville, Louisville, Kentucky
  • Footnotes
    Commercial Relationships  Shiao Hui M. Liew, Pfizer (E); Kelly K. Nichols, Alcon (C), Alcon (travel reimbursement) (R), Allergan (C), Allergan (travel reimbursement) (R), Inspire (C), Inspire (travel reimbursement) (R), Pfizer (C), Pfizer (travel reimbursement) (R), TearLab (C); Karen Klamerus, Pfizer (E); Jim Z. Li, Pfizer (E); Min Zhang, Pfizer (E); Gary N. Foulks, Alcon (C), Allergan (C), Alson (I), Bausch and Lomb (C), Inspire (I, C), Pfizer (C)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science April 2011, Vol.52, 4246. doi:
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      Shiao Hui M. Liew, Kelly K. Nichols, Karen Klamerus, Jim Z. Li, Min Zhang, Gary N. Foulks; Safety and Efficacy of Topical Ophthalmic CP-690,550, a Janus Kinase Inhibitor, for Dry Eye Disease: A Phase 1/2 Clinical Trial. Invest. Ophthalmol. Vis. Sci. 2011;52(14):4246.

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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose: : To evaluate safety and efficacy of topical ophthalmic CP-690,550 (CP), a novel, selective Janus kinase inhibitor which is being investigated as a treatment for moderate-to-severe dry eye disease (DED), in a Phase 1/2, randomized, double-blind, multicenter, placebo- and comparator-controlled trial.

Methods: : Patients aged ≥18 years with diagnosis of DED ≥6 months were selected for inclusion based on signs and symptoms of DED as characterized by Schirmer test, corneal fluorescein staining, and an expanded Ocular Comfort Index (OCI) questionnaire. Patients were randomized equally to 0.0003%, 0.001%, 0.003%, 0.005% twice-daily (BID) CP, 0.005% CP once daily (QD), vehicle control BID, or 0.05% cyclosporine ophthalmic emulsion (COE) BID. Safety and efficacy evaluations were performed at Baseline and throughout the 8-week study.

Results: : 327 eligible patients were randomized. All doses of CP appeared to have a reasonable safety profile and were well tolerated. The most common adverse events (AEs) reported were eye irritation and blurred vision; however, these were infrequent (maximum of 2 patients reporting each AE in a single treatment group). CP exhibited significantly (p<0.2, two-sided) improved patient-reported ocular tolerability compared with COE. All CP treatment groups showed significant improvements from Baseline in both signs (Schirmer test [mean increase, range 1.7-3.2 mm]; complete clearance of corneal staining [mean, range 4.3-15.9%]) and symptoms (OCI [mean improvement, range 6.7-10.3], Ocular Surface Disease Index (OSDI) scores [mean improvement, range 6.9-13.6]). Significant improvements over vehicle were observed in the 0.005% CP QD group in the objective (Schirmer test) and subjective endpoints (OSDI environmental triggers subscale). CP dose groups also showed significant improvements in corneal staining and subjective endpoints compared with COE.

Conclusions: : Topical ophthalmic CP demonstrates promising results as a novel treatment which improves both the signs and symptoms of DED in this first-in-patient DED study.

Clinical Trial: : http://www.clinicaltrials.gov NCT00784719

Keywords: cornea: tears/tear film/dry eye • autoimmune disease 

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