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
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Patient satisfaction with Visual Analog Scale (0-10) at week 12 - Descriptive analysis
研究概览
简要总结
The goal of this prospective, open, monocentric study is to evaluate the clinical efficacy of a new preservative-free combination of trehalose, sodium hyaluronate and NAAGA in 30 patients with chronic dry eye disease and associated ocular surface inflammation.
The main question it aims to answer is:
- To assess the improvement of conjunctival hyperemia as well as subjective symptoms in patients with moderate to severe dry eye.
Participants will be asked to use T2769 on a daily basis.
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
- •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
- •Sjogren Syndrome
- •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.
- •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
Patient satisfaction with Visual Analog Scale (0-10) at week 12 - Descriptive analysis
时间窗: at week 12
Scores will be determined using a 100 mm VAS on which 0 means "I do not agree" and 100 means "I totally agree". The following questions will be assessed using VAS: "I feel satisfied using this treatment" "With these eye drops, I have a feeling of freshness" "With these eye drops, I have a feeling of relief" "This product contributed to reduce my pain due to eye dryness" "This product is comfortable"
Conjunctival hyperaemia assesment with Efron scale at week 12
时间窗: week 12
Conjunctival hyperemia grading with Photographs (Efron) scale at week 12 * Descriptive analysis * Cross table baseline vs week 12; McNemar Bowker (0) = None 1. = Trace 2. = Mild 3. = Moderate 4. = Severe
次要结局
未报告次要终点