Therapeutic fluid-gels for eye disease: Ocular Surface Disease. A phase I/IIa safety trial evaluating allogeneic donor serum gel in patients with severe ocular surface disease (OPtiCS-OSD)

niversity of Birmingham0 个研究点目标入组 36 人2023年8月21日

概览

暂无简介。

注册库

who.int

开始日期

2023年8月21日

结束日期

2026年6月18日

最后更新

去年

研究类型

Interventional

性别

All

发起方

•1\. \=16 years of age
•2\. Moderate to severe dry eye symptoms (Ocular surface disease index (OSDI) score \=33\)
•3\. Lubricant requirement \= 2 hourly
•4\. Stable on their current Serum Eye Drop (SED) therapy for \>3 months (defined as no need for acute intervention in preceding 3 months) or have previously used SED as part of their ocular therapy

•For Stages 1 and 2:
•1\. Unwilling to stop wearing contact lenses for the duration of the trial
•2\. Active seasonal allergic conjunctivitis (hay fever)
•3\. Presence of active ophthalmic infection: bacterial, fungal or viral
•4\. Presence of persistent infective corneal ulcers or current eye condition impacting on the trial as judged by a clinician
•5\. Known hypersensitivity to any of the components of the trial or procedural medication
•6\. History of drug, medication or alcohol abuse or addiction
•7\. Unable to understand, speak and write the English language
•8\. Vision insufficient to be able to do all the assessments as judged by the participant
•9\. Use of any investigational agent within 4 weeks of trial entry