NCT01382810Unknown4 期
A Randomized Masked Evaluation of Altaire Gel Forming Solution Versus Refresh Tears for the Treatment of Dry Eye Signs and Symptoms
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- TBUT
研究概览
简要总结
The purpose of this study is to evaluate and compare the effects of Altaire Gel forming solution and Refresh Tears in mild-moderate dry eye patients.
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 (Participant)
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
- •Patients 18 years or older.
- •Males or females.
- •Patient reported dry eye symptoms (episodic, annoying, activity limiting).
- •Physician assessment of mild-moderate dry eye.
- •Patient willing to instill drops TID and complete entire length of protocol.
- •TBUT _< 10 seconds.
- •At least Grade 6 Corneal Staining.
排除标准
- •Current topical cyclosporine use (Restasis)
- •Current Refresh use.
- •Refractive surgery within the last 6 months.
- •Oral or topical corticosteroid use.
- •Severe dry eye patients by physician assessment.
- •Current active blepharitis.
- •Oral doxycycline use.
- •Oral antihistamine use.
研究组 & 干预措施
Altaire Gel forming solution
Active Comparator
干预措施: Altaire Gel forming solution (Drug)
Refresh Tears
Placebo Comparator
干预措施: Refresh Tears (Drug)
结局指标
主要结局
TBUT
时间窗: 2 months
Test performed that measures how long the tears take to break up
Conjunctival and Corneal staining
时间窗: 2 months
Dye that will be placed inside the eye to evaluate the surface of the ey
次要结局
未报告次要终点
研究者
研究点 (2)
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