NCT00620893已完成4 期
Bilateral, Masked Comparison of PEG-400 Based Artificial Tear vs. Systane for Dry Eye Signs, Symptoms & Refractive Regression Associated With Myopic Laser in Situ Keratomilieusis (LASIK).
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
- 100
- 试验地点
- 1
- 主要终点
- dry eye signs
研究概览
简要总结
This study will evaluate and compare 2 artificial tears in their ability to reduce post LASIK dry eye signs and symptoms. The secondary endpoint of this study is to evaluate refractive regression in these patients. The 'Refractive Outcome' data point will be defined as the difference between the post-op spherical equivalent (SE) and the pre-op targeted SE.
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
- •Patients ranging from normal to mild dry eye per physician assessment
- •BCVA of 20/20
- •Moderate to high myopia (-3 D to -10D of sphere)
- •Patients who are scheduled to under go myopic bilateral LASIK with VISX laser
排除标准
- •Patients currently using topical cyclosporine
- •Patients currently using Systane
- •Patients currently using an oil-based artificial tear such as Soothe or Endura
- •Any post-op epithelial defects or flap complications requiring further procedures (relifting, scraping, stretching etc.)
- •DLK greater than stage 1 or infectious keratitis post-operatively
- •Any uncontrolled systemic disease that may confound the results of this trial (Diabetes, Lupus, Rheumatoid Arthritis etc.)
- •Anisometropia greater than 1D
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: 9 months
次要结局
- refractive regression(9 months)
研究者
研究点 (1)
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