NCT00544713已完成不适用
Evaluate the Safety and Efficacy of a New Artificial Tear for Use After LASIK Surgery
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
- 228
- 主要终点
- Post LASIK Dry Eye Symptoms as Measured by Ocular Surface Disease Index (OSDI©) Score at Day 90
研究概览
简要总结
This study will evaluate the safety and efficacy of a new artificial tear for the treatment of dry eye that may occur after LASIK surgery
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
- •Candidate for bilateral LASIK surgery for myopia correction in the range of -1.00 to -8.00 diopters
排除标准
- •Dry eye signs and symptoms
- •Preoperative soft or rigid contact lens wear within last 7 or 30 days, respectively
- •Pregnancy or planning pregnancy
- •Uncontrolled systemic disease
- •Use of systemic medications affecting dry eye
研究组 & 干预措施
Carboxymethylcellulose and Glycerin based artificial tear
Experimental
Carboxymethylcellulose and Glycerin based artificial tear
干预措施: Carboxymethylcellulose and Glycerin based artificial tear (Drug)
Carboxymethylcellulose based artificial tear
Active Comparator
Carboxymethylcellulose based artificial tear
干预措施: Carboxymethylcellulose (Drug)
结局指标
主要结局
Post LASIK Dry Eye Symptoms as Measured by Ocular Surface Disease Index (OSDI©) Score at Day 90
时间窗: Day 90
Measured on 12 domains (categories); a 5-point scale for each domain (0 = best, no dry eye symptoms, 4 = worst, constant dry eye symptoms). Sum of the domain scores is normalized (standardized) to a severity scale of 0-100 (0 = no symptoms (best score), 100 = maximum severity (worst score)).
次要结局
- Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90(Day 90)
- Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90(Day 90)
- Best Corrected Visual Acuity (BCVA) Status at Day 90(Day 90)
- Change From Baseline of the Worse Eye in Corneal Topography as Measured by Pentacam at Day 90(Baseline, Day 90)
- Change From Baseline of the Worse Eye in Corneal Topography Measured by Humphrey Atlas at Day 90(Baseline, Day 90)
- Change From Baseline of Total Higher Order Aberration (HOA) of the Worse Eye at Day 90(Baseline, Day 90)
- Change From Baseline of the Worse Eye in Schirmer's Test at Day 90(Baseline, Day 90)
- Change From Baseline of the Worse Eye in Corneal Staining With Fluorescein at Day 90(Baseline, Day 90)
- Change From Baseline of the Worse Eye in Conjunctival Staining With Lissamine Green at Day 90(Baseline, Day 90)
- Change From Baseline of the Worse Eye in Tear Break-Up Time (TBUT) at Day 90(Baseline, Day 90)
- Change From Baseline in Study Product Usage at Day 90(Baseline, Day 90)
研究者
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