NCT00622037已完成4 期
Bilateral, Masked Comparison of PEG-400 Based Artificial Tear and Systane for the Treatment of Dry Eye Signs, Symptoms and Visual Quality
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Dry Eye Signs
研究概览
简要总结
To evaluate and compare the effects of PEG-400 based artificial tear and Systane tears in mild-moderate dry eye patients. TBUT, Visual impact and subjective evaluations will be assessed in this month long trial.
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 (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
- •Patient reported dry eye symptoms (episodic, annoying, activity limiting), SES OD.
- •Physician assessment of mild-moderate dry eye
- •Patient willing to instill drops QID and complete entire length of protocol.
- •TBUT < 10 seconds
- •BCVA of 20/30 or better
排除标准
- •Current topical cyclosporine use (Restasis)
- •Current Systane use
- •Refractive surgery within the last 6 months
- •Oral or topical corticosteroid use
- •Severe dry eye patients by physician assessment
- •current active Blepharitis
- •Oral Doxycyclines use
- •Oral Antihistamine use
研究组 & 干预措施
1
Active Comparator
PEG-400 based artificial tear
干预措施: PEG-400 based artificial tear (Drug)
2
Active Comparator
Systane
干预措施: Systane (Drug)
结局指标
主要结局
Dry Eye Signs
时间窗: 4 months
次要结局
- Visual Quality(4 months)
研究者
研究点 (1)
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