A Multicenter, Open Label, Interventional, Prospective, Non Randomized, One Cohort Extension Study To Assess the Sustainability of the Effect of NOVA22007 Following Treatment Discontinuation in Improved Patients With Severe Dry Eye Disease (DED)

OVAGALI Pharma S.A.S0 个研究点目标入组 125 人开始时间: 2012年10月18日最近更新: 2015年10月19日

试验速览

暂无简介。

•1. Patient completed the main study (NVG10E117).
•2. Patient was treated with NOVA22007 during the last 6 months.
•3. Patient has a CFS score = 3 at least at one visit after Month 6 (i.e. Month 6 visit excluded and Month 12 visit included, whether it be at a planned visit or an unscheduled visit).
•4. Patient must provide written informed consent for the extension study.
•5. Patient must be willing and able to undergo and return for scheduled study-related examinations
•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 65
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 65

•Patients will not be eligible for inclusion in the extension study if one of the following criteria is met:
•1. Drop out from the main study (NVG10E117).
•2. Completion of last visit Month 12 of the main study (NVG10E117) more than 2 weeks ago.
•3. Resistance to treatment. A patient is considered treatment resistant at Month 12 if if at all visits after Month 6, CFS score was at grade 4 or 5 (i.e. Month 6 visit excluded and Month 12 visit included, whether it be at a planned visit or an unscheduled visit).
•4. Active herpes Keratitis or history of ocular herpes.
•5. Active ocular infection (viral, bacterial, fungal, protozoal).
•6. Presence or history of any systemic or ocular disorder, condition ordisease that could possibly interfere with the conduct of the required study procedures or the interpretation of study results or judged by the investigator to be incompatible with the study.
•7. Women of childbearing potential not using a medically acceptable, highly effective method of birth control (such as hormonal implants, injectable or oral contraceptives together with condoms, some intrauterine devices, sexual abstinence or vasectomized partner) throughout the conduct of the study treatment periods and up to 2 weeks after the study end. Post-menopausal women (two years without menstruation) do not need to use any method of birth control.
•8. Current participation in another clinical trial than the main study.

发起方

OVAGALI Pharma S.A.S