A phase 2 randomized, double-masked, placebo-controlled study of novel nonsystemic kinase inhibitor TOP1630 for the treatment of dry eye disease
Clinical Ophthalmology Feb 22, 2019
Taylor M, et al. - In this randomized, double-masked, parallel-group trial, researchers estimated 61 subjects to analyze the safety and efficiency of topical TOP1630 (a novel nonsystemic kinase inhibitor) in dry eye disease (DED). They observed no serious adverse events (AEs) or withdrawals due to treatment-emergent AEs. They noticed improvements in symptoms with TOP1630 vs placebo for ocular discomfort (post-CAE), grittiness/foreign body sensation (on 4 independent assessment scales), worst DED symptom (diary), and ocular pain. Improvements in signs were also noted for total ocular surface (all fields), corneal sum, and conjunctival sum staining with TOP1630 as compared to placebo. Overall, they suggested that the emergent TOP1630 benefit-risk profile for DED treatment was highly favorable.
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