NCT07234318已完成不适用
A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Dryness score assessed by a VAS and Conjunctival hyperemia grading with Photographs (Efron) scale at week 12
研究概览
简要总结
The FOCUS study aims to evaluate the clinical efficacy of 0.1% cyclosporine eye drops solution (Vevizye®, Laboratoires THEA) in patients with moderate to severe dry eye disease characterized by ocular surface inflammation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •No patients with other ophthalmic diseases than DED
- •Chronic dry eye defined as longer than six months since diagnosis
- •OSDI score > 22
- •Conjunctival Hyperemia ≥ Grade 3 (Efron Scale)
- •Current use of tear substitutes for at least 3 months not to be considered as sufficient by the investigator/treating physician
- •Need to add cyclosporine eye drops to tear substitutes as judged by the investigator/treating physician
排除标准
- •Ophthalmic exclusion criteria
- •Far best corrected visual acuity < 1/10
- •Severe Dry Eye associated with:
- •Eyelid malposition
- •Stevens Johnson Syndrome
- •Corneal dystrophy
- •Ocular neoplasia
- •Filamentous keratitis
- •Corneal neovascularisation
- •Orbital radiotherapy
- •Dry eye related to Graft Versus Host Disease (GVHD)
- •History of any of the following within last 3 months:
- •Systemic treatment of dry eye
- •Systemic treatment of Meibomian Gland Dysfunction (MGD)
- •Isotretinoïde,
- •Cyclosporine,
- •Tacrolimus, Siromilus, Pimecrolimus
- •Punctual plugs
- •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
- •Systemic / non ophthalmic exclusion criteria:
- •Known hypersensitivity to any of the components of the medical product under investigation or other study medication
- •Specific exclusion criteria for women:
- •Pregnant or breast-feeding woman.
- •Woman of childbearing potential (neither menopausal, nor hysterectomized, nor sterilized) not using effective contraception (i.e. hormonal contraceptives, intra-uterine device, contraceptive implant or condoms with spermicide)
- •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
结局指标
主要结局
Dryness score assessed by a VAS and Conjunctival hyperemia grading with Photographs (Efron) scale at week 12
时间窗: at week 12 versus baseline
Scores will be determined using a 100 mm VAS on which 0 means "no feeling of eye dryness" and 100 means "most imaginable feeling of eye dryness".
次要结局
未报告次要终点
研究者
研究点 (1)
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