Anti-inflammatory Effects and Clinical Efficacy of Topical Thealoz Total Eye Drops in Patients With Chronic Dry Eye Disease and Associated Ocular Surface Inflammation
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Patient satisfaction assessed by a VAS
研究概览
简要总结
Dry eye disease (DED) is a highly prevalent ocular condition and induces a significant burden to the affected patients. Regardless of the underlying etiology, DED is associated with increased inflammation of the entire ocular surface including the adnexa, conjunctiva and cornea. As such, there is evidence from in vitro, animal and clinical studies that this inflammatory response of the ocular surface plays a pathophysiological key role in the development of DED. The Dry Eye Workshop 2007 (DEWS) therefore suggests beside of restoring the tear film by administering topical lubricants, breaking the vicious circle of inflammation is an important mainstay of therapy in patients with DED. Recently, a new medical device (Thealoz Total® eye drops) has been introduced for the treatment DED. Thealoz Total® eye drops are based on hyaluronic acid and exert their main action by lubricating the ocular surface. Further, this new formulation offers several advantages that make them potentially interesting to reduce DED related symptoms. First, the formulation is preservative-free, which is of special importance in patients with DED, since it has been shown that preservatives are detrimental for the ocular surface. thereby reducing signs and symptoms related to DED. Secondly, in addition to the lubricating effect of hyaluronic acid, Thealoz Total eye drops also contain trehalose, which exerts osmoprotetive effects and N-Acetyl Aspartyl Glutamic Acid (NAAGA). NAAGA is an amino conjugated dipeptide with anti-inflammatory properties. Thus, it is reasonable to hypothesize that Thealoz total eye drops are also capable of reducing ocular surface inflammation. The aim of the present study is to investigate whether topical administration with Thealoz Total® improves ocular surface inflammation as well as clinical signs and symptoms associated with DED.
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
- •Normal ophthalmic findings except dry eye disease
- •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
排除标准
- •Ophthalmic exclusion criteria
- •- Best far 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 GVHD
- •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
- •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 device 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)
- •Exclusion criteria related to general conditions
- •- Inability of patient to understand the investigation procedures and thus inability to give valid, informed consent.
研究组 & 干预措施
Thealoz Total® eye drops
Thealoz Total® eye drops; 3-6 Drops per day for 12 weeks
干预措施: Thealoz Total® Eye Drops, Laboratoires Thea, Clermont Ferrand, France (Drug)
结局指标
主要结局
Patient satisfaction assessed by a VAS
时间窗: week 12
Patient satisfaction assessed by a Visual Analogue Scale (VAS) (min 0 - max 100) The VAS consists of a 10cm line, with two end points representing 0 ('no symptoms') and 100 ('max symptoms')
Conjunctival hyperemia grading with Photographs (Efron) scale at week 12
时间窗: week 12
Conjunctival hyperemia grading with Photographs (Efron) scale at week 12 The Efron Scale is a clinical grading scale used to assess conjunctival hyperemia. It provides a standardized visual grading from 0 to 4 Grade 0 = normal Grade 1 = trace / very mild Grade 2 = mild to moderate Grade 3 = moderate to severe Grade 4 = severe
次要结局
- Changes from baseline in conjunctival hyperemia grading with photographs (Efron) scale(week 6 and 12)
- Changes from baseline in corneal fluorescein staining according to the Oxford Scale(week 6 and 12)
- Changes from baseline in Tear Break Up Time (BUT) with Minims- Fluorescein Sodium 2,0%(week 6 and 12)
- Changes from baseline in Schirmer I test using Schirmer paper strips(week 6 and 12)
- Changes from baseline in conjunctival hyperaemia assessment using Mc Monnies photographic scale(week 6 and 12)
- Changes from baseline in symptoms using the OSDI questionnaire(week 6 and 12)
- Changes from baseline in symptoms within the last 48 hours(week 6 and 12)
- Changes from baseline in tear proteomics and lipidomics(week 12)
- Patient satisfaction assessed by a VAS(week 12)
研究者
Doreen Schmidl
Assoc. Prof. Priv. Doz. Dr., PhD
Medical University of Vienna