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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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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.
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.
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.
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.
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