A phase 2 randomized, double-masked, placebo-controlled study of novel nonsystemic kinase inhibitor TOP1630 for the treatment of dry eye disease

Autor: Taylor M, Ousler G, Torkildsen G, Walshe C, Fyfe MCT, Rowley A, Webber S, Sheppard JD, Duggal A
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Zdroj: Clinical Ophthalmology, Vol Volume 13, Pp 261-275 (2019)
Druh dokumentu: article
ISSN: 1177-5483
Popis: Mike Taylor,1 George Ousler,2 Gail Torkildsen,3 Claire Walshe,1 Matthew C T Fyfe,1 Adele Rowley,1 Steve Webber,1 John D Sheppard,4 Ajay Duggal1 1TopiVert Pharma Limited, London, UK; 2Ora Inc., Andover, MA, USA; 3Andover Eye Associates, Andover, MA, USA; 4Virginia Eye Consultants, Norfolk, VA, USA Purpose: To evaluate the safety and efficacy of topical TOP1630, a novel nonsystemic kinase inhibitor, in dry eye disease (DED).Patients and methods: A randomized, double-masked, parallel-group trial of 0.1% TOP1630 ophthalmic solution TID or placebo (vehicle without active drug) was conducted in DED subjects (n=61). Key eligibility criteria consistent with enrolling a moderate to severe DED population included >6 months DED history; OSDI© score ≥18; Schirmer’s test score ≤10 and ≥1 mm/5 minutes; tear film break-up time >1 and
Databáze: Directory of Open Access Journals
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