EUCTR2017-003285-27-AT进行中（未招募）1 期
Clinical efficacy of topical hydrocortisone 0.335% (Softacort®) in patients with chronic dry eye disease and associated ocular surface inflammation - Softacort Study
aboratoires Thea0 个研究点目标入组 60 人开始时间: 2017年8月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •-Age = 18 years
- •-Normal ophthalmic findings except dry eye disease
- •-Ametropy = 6 diopters
- •-Chronic dry eye defined as longer than six months since diagnosis
- •-OSDI = 22
- •-Conjunctival Hyperemia= Grade 3 (Efron Scale)
- •-Current use of topical lubricants since at least 3 months
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Ophthalmic exclusion criteria
- •Best far corrected visual acuity < 1/10
- •Severe Dry Eye associated with:
- •-Eyelid malposition
- •-Sjogren Syndrome
- •-Stevens Johnson Syndrome
- •-Corneal dystrophy
- •-Ocular neoplasia
- •-Filamentous keratitis
- •-Corneal neovascularisation
- •-Orbital radiotherapy
- •History of any of the following within last 3 months:
- •Systemic treatment of dry eye
- •Systemic treatment of MGD
- •Isotretinoïde,
- •Cyclosporine,
- •Tacrolimus, Siromilus, Pimecrolimus
- •Punctual plugs
- •Anti-glaucoma treatment
- •History of any of the following within previous six months:
- •ocular trauma
- •ocular infection, Ocular allergy
- •History of any of the following within last 12 months:
- •inflammatory corneal ulcer
- •Herpetic eye infection
- •or uveitis
- •Ocular surgery
- •History of IOP increase caused by systemic or topical treatment with corticosteroids
- •IOP > 22mmHg
- •Glaucoma in the medical history
- •Systemic / non ophthalmic exclusion criteria:
- •Known hypersensitivity to any of the components of the IMP under investigation or other study medication
- •Allergic rhinitis; active or susceptible to reactivation during the study
- •Specific exclusion criteria for women:
- •Pregnant or breast-feeding woman.
- •Woman of childbearing potential (neither menopausal, nor hysterectomized, nor sterilized) not using effective contraception (oral contraceptives, intra-uterine device, contraceptive implant or condoms)
- •Exclusion criteria related to general conditions
- •Inability of patient to understand the investigation procedures and thus inability to give valid, informed consent.
- •Non-compliant patient (e.g. not willing to attend the follow-up visits, way of life interfering with compliance)
- •Participation in another clinical study or clinical investigation at the same time as the present investigation
- •Participation to the present clinical investigation during the exclusion period of another clinical study
- •Patient already included once in this clinical investigation
- •Patient under guardianship
研究者
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