Phase III comparative clinical trial to evaluate the efficacy of amniotic membrane extract for the treatment of severe dry eye disease, in comparison with autologous serum eyedrops.

Clínica Universidad de Navarra/Universidad de Navarra0 个研究点目标入组 50 人开始时间: 2012年1月11日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•Patients must be able to provide informed consent and express their desire tu fulfil every requirement during the study.
•Patients between 18 and 65 years old.
•Patients diagnosed with severe dry eye disease according to DEWS classification.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 50
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Systemic disease that can compromise patients participation in the study, according to investigator (hepatic failure, etc?)
•Previous ocular surgeries that can alter or modify the ocular surface (refractive surgery, palpebral surgery, corneal surgery)
•Patient is under systemic medication that can affect tear production.
•Contact lens wear.
•Concomitant palpebral pathology (lagoftalmos, exoftalmos, ectropion, etc?)

发起方