NCT00135824已完成4 期
Local Tolerability and Safety of Povidone K25 (Artificial Tears Containing Povidone) vs. Placebo in Healthy Volunteers
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- ocular discomfort by using a visual analogue scale (VAS)
研究概览
简要总结
Instillation of artificial tears is standard treatment in dry eye syndrome and in patients experiencing dry eye symptoms when wearing contact lenses. Povidone K25 eye drops (povidone) is an isotonic solution containing povidone to simulate normal tears viscosity. Safety and local tolerability of Povidone K25 is evaluated in healthy volunteers in comparison to placebo eye drops.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects
- •Older than 18 years
- •Ocular discomfort less than 20 mm on 100 mm visual analogue scale (VAS) prior to treatment
排除标准
- •Known hypersensitivity to any of the constituents of the medications
- •Known allergic disposition (e.g. hay fever)
- •Wearing of contact lenses
- •Any kind of current eye disease (e.g. dry eye)
- •Additional exclusion criteria are defined in the protocol
结局指标
主要结局
ocular discomfort by using a visual analogue scale (VAS)
次要结局
- slit lamp assessment (conjunctival edema, palpebral hyperemia, lid edema)
- adverse events
研究者
研究点 (2)
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