NCT00514852已完成不适用
Safety and Efficacy of an Artificial Tear for the Treatment of Dry Eye
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 316
- 主要终点
- Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score
研究概览
简要总结
The efficacy, safety and acceptability of a new artificial tear in subjects with dry eye will be compared to a currently-available artificial tear
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
- 否
入选标准
- •Mild, moderate or Severe Symptoms of Dry Eye
排除标准
- •Uncontrolled systemic disease
- •Use of systemic medications affecting dry eye
- •Pregnancy or planning a pregnancy
- •Contact lens wear
研究组 & 干预措施
1
Experimental
Carboxymethylcellulose and Glycerin based artificial tear
干预措施: Carboxymethylcellulose and Glycerin based artificial tear (Drug)
2
Active Comparator
Carboxymethylcellulose
干预措施: Carboxymethylcellulose (Drug)
结局指标
主要结局
Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score
时间窗: Change from baseline at Day 30
Ocular Surface Disease Index© Questionnaire Score is measured on 12 domains; a 5-point scale (0-4) for each domain. Sum of the domain scores is normalized to a severity scale of 0-100 (0 = no symptoms, 100 = maximum severity)
次要结局
- Change From Baseline at Day 30 in Schirmer Test, With Anesthesia(Change from baseline at Day 30)
- Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein(Change from baseline at Day 30)
- Patient Acceptability Score (Dryness) at Day 30(Day 30)
- Patient Acceptability Score (Vision) at Day 30(Day 30)
- Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein(Change from baseline at Day 30)
- Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein(Change from baseline at Day 30)
- Change From Baseline at Day 30 in Subjective Evaluation of Symptom of Dryness Score(Change from baseline at Day 30)
研究者
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