NCT01227226Unknown4 期
Tear Osmolarity Over Time With Artificial Tears
Hom, Milton M., OD, FAAO1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2010年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Tear osmolarity
研究概览
简要总结
The effect of artificial tears on tear osmolarity
详细描述
Tear osmolarity measures the amount of solutes in the human tear film. The higher the reading, the more likely the patient has dry eyes. Some say it has "potential to be the gold standard" of dry eye testing. The investigators study the tear osmolarity at different time points after instillation of artificial tears.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
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
- •Between the ages of 18 and over inclusive. Males or females Any race or ethnic background Patient is in generally good & stable overall health. Patient likely to comply with study guidelines & study visits. Informed consent signed. Subjective evaluation of symptom of dryness (SESoD): Score 2 (Mild)
排除标准
- •Corneal refractive surgery within 6 months of this study. Intra-ocular surgery within 6 months or ocular laser surgery within 6 months. Pregnant or lactating women. Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.
- •Corneal staining Grade 3 or higher No Restasis for past 3 months Discontinue topical medications for at least 1 week
研究组 & 干预措施
Refresh tears
Active Comparator
Allergan's Refresh tears artificial tear
干预措施: Artificial tears (Drug)
Systane Ultra
Active Comparator
Alcon's Systane Ultra artificial tear
干预措施: Artificial tears (Drug)
Visine
Active Comparator
Visine artificial tear
干预措施: Artificial tears (Drug)
Blink tears
Active Comparator
AMO's blink tears artificial tear
干预措施: Artificial tears (Drug)
结局指标
主要结局
Tear osmolarity
时间窗: 2 days
Tear osmolarity measured with TearLab instrument
次要结局
未报告次要终点
研究者
研究点 (1)
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