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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Dryness score assessed by a Visual Analog Scale (VAS) and Conjunctival hyperemia grading with Photographs (Efron) scale at week 12
研究概览
简要总结
Dry eye disease (DED) is a common, multifactorial ocular surface condition with increasing worldwide prevalence. DED induces a significant burden to the patients. Inflammatory responses involving the ocular surface including the adnexa, conjunctiva and cornea are recognized as central to its pathophysiology, as supported by in vitro, non-clinical and clinical studies. Although tear substitutes remain the mainstay of initial management, in some patients this is not sufficient to control ocular surface inflammation and associated symptoms. A new medical product (Vevizye® eye drops) has been recently approved for the treatment of DED. It contains cyclosporine 0.1% as an active ingredient and pefluorobutylpentane as vehicle. Topical cyclosporine is a well-established treatment for patients with moderate to severe DED who do not achieve sufficient clinical benefit from topical lubricants alone. Perfluorobutylpentane has been found to improve the bioavailability of cyclosporine and has a long residence time for up to 8 hours. In addition, because of its low surface tension facilitates quick and uniform spreading improving the tear film layer. 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 DED characterized by ocular surface inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Need to add cyclosporine eye drops to tear substitutes as judged by treating physician prior to and independently of study participation
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
- •Ocular surgery
- •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
研究组 & 干预措施
Vevizye® Eye Drops
Vevizye® Eye Drops, Laboratoires Thea, Clermont Ferrand, France
Administration scheme: 2 times daily for 12 weeks with a 12h time interval Ingredients: Cyclosporine 1mg/mL, Perfluorobutylpentane, Ethanol, anhydrous
干预措施: Vevizye® Eye Drops (Drug)
结局指标
主要结局
Dryness score assessed by a Visual Analog Scale (VAS) and Conjunctival hyperemia grading with Photographs (Efron) scale at week 12
时间窗: Week 0 - Week 12
Dryness score assessed by a VAS score 0-100; min 0; max 100 Unit: millimeters and Conjunctival hyperemia grading with Photographs (Efron) scale at week 12 score: 0-4; min 0, max 4
次要结局
- Changes from baseline in conjunctival hyperemia grading with photographs (Efron) scale(At weeks 2, 4, 8 & 12:)
- Change from baseline in dryness score (VAS)(At weeks 2, 4, 8 & 12:)
- Changes from baseline in corneal fluorescein staining according to the NEI Scale(At weeks 2, 4, 8 & 12:)
- Changes from baseline in Tear Break Up Time (BUT) with Minims- Fluorescein Sodium 2,0%(At weeks 2, 4, 8 & 12:)
- Changes from baseline in lipid layer thickness(At weeks 2, 4, 8 & 12:)
- Changes from baseline in tear film osmolarity(At weeks 2, 4, 8 & 12:)
- Changes from baseline in Schirmer I test using Schirmer paper strips(At weeks 2, 4, 8 & 12:)
- Changes from baseline in conjunctival hyperemia assessment using Mc Monnies photographic scale(At weeks 2, 4, 8 & 12)
- Changes from baseline in symptoms and quality of life using the OSDI questionnaire(At weeks 2, 4, 8 & 12:)
- Changes from baseline in symptoms within the last 48 hours(At weeks 2, 4, 8 & 12)
- Patient satisfaction assessed by a VAS(At week 12)
研究者
Doreen Schmidl
Assoc. Prof. Priv. Doz. Dr., PhD
Medical University of Vienna