NCT04803240已完成不适用
Survey: Evaluation of Ocular Surface Disease Symptoms and Patient Satisfaction With Thealoz® Duo After 84 Days of Daily Treatment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- OSDI
研究概览
简要总结
Multi-centre, international, non-interventional, prospective survey
详细描述
To assess after 84 days, on a large scale patient population, the evaluation of ocular surface diseases and the satisfaction of dry eye disease (DED) treatment naïve patients or those who had to switch for tolerance, dissatisfaction or efficacy reasons to Thealoz® Duo.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •All dry eye patients who require artificial tears or need to change their current artificial tears for any reason (i.e. due to dissatisfaction or low efficacy, etc...)
- •Outpatients of either sex, aged at least 18 years
- •Patients informed of the objectives of the survey and agreeing to participate.
排除标准
- •Use of cyclosporine, lifitegrast, tacrolimus, sirolimus within last 3 months and during the survey
- •Use of topical ophthalmological treatments (glaucoma, etc...)
- •Use of lacrimal plugs
- •Ocular surgery in the last 12 months
- •Concomitant use of corticosteroids
- •Concomitant use of autologous serum or any blood derivatives
- •Severe blepharitis
- •Severe dry eye associated to
- •Eyelid malposition
- •Corneal dystrophy
- •Ocular neoplasia
- •Sjogren syndrome
- •Any systemic pathologies
- •Pregnancy/lactation
结局指标
主要结局
OSDI
时间窗: 84 days
Change from baseline for patient symptoms using the ocular surface disease index (OSDI©) questionnaire at Day 84. The OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability.
次要结局
未报告次要终点
研究者
研究点 (1)
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