Effects of a Moisturizing Product on Dry Eye and Skin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change in tear film break-up time (s)
研究概览
简要总结
Dry eye is a common syndrome associated with symptoms of dryness, burning, itching and grittiness of eyes. The objective of this study is to investigate the effects of a moisturizing product in liquid formula on symptoms and signs of dry eye and on skin around the eyes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Dry eye symptoms OSDI score 20 or higher
- •Dryness, burning or foreign body sensation moderate or higher
排除标准
- •Severe eye diseases
- •Known allergy to any of the ingredients of the product
- •Laser surgery of eyes during the last year
结局指标
主要结局
Change in tear film break-up time (s)
时间窗: Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days
Change in transepidermal water loss from skin around the eyes (g/m2h)
时间窗: Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days
Change in tear film osmolarity (mOsm/L)
时间窗: Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days
Change in tear secretion, Schirmer test (mm/min)
时间窗: Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days
Change in symptoms of dry eye: Ocular Surface Disease Index (OSDI), scores of dryness, burning and foreign body sensation of eyes
时间窗: Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days
Change in signs of irritation of eyes, scoring by an eye specialist
时间窗: Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days
次要结局
- Change in other symptoms of dry eye: soreness, grittiness, watery eyes, redness, blurring of eyes (daily symptom logbooks: scoring in scale from 0 to 3)(Part 2: change from baseline to 9 days; Part 3: change from baseline to 45 days)
研究者
Petra Larmo
Ph.D., R&D Manager
Aromtech Ltd.