To Evaluate the Physical Effects of Systane(R) Lubricant Eye Drops Compared to Refresh Tears(R) Lubricant Eye Drops
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- To evaluate physical effects of Systane and Refresh Tears in subjects to moderate to severe dry eye.
研究概览
简要总结
This is a multi-site, randomized, investigator-masked study to evaluate the physical effects of Systane(R) versus Refresh Tears(R) in subjects with moderate to severe dry eye. It is a 6-week, perspective, randomized, active-controlled, investigator-masked, parallel group study.
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
- •Patient must be 18 years of age or older of any sex and any race, with a score of at least 2 (some of the time) on the subject-assessed Symptom Eligibility question.
- •A sodium fluorescein corneal staining sum of ≥ 3 in either eye.
- •A best-corrected visual acuity of 0.6 logMAR or better in each eye as assessed using an ETDRS chart.
排除标准
- •A history or evidence of ocular or intraocular surgery in either eye within the past 6 months.
- •Lasik patients can be included if lasik surgery was greater than 6 months prior to the initiation of the study.
- •A history of intolerance or hypersensitivity to any component of the study medications.
研究组 & 干预措施
Refresh Tears
Refresh Tears Lubricant Eye Drops
干预措施: Refresh Tears (Other)
Systane
Systane Lubricant Eye Drops
干预措施: Systane (Other)
结局指标
主要结局
To evaluate physical effects of Systane and Refresh Tears in subjects to moderate to severe dry eye.
时间窗: Baseline to visit 3 (Day 42)
This is a descriptive study in which changes from baseline in Tear Break up Time, corneal staining, and the Ocular Symptoms Questionnaire will be evaluated by treatment group at every visit. The outcome of the IDEEL questionnaire at Visit 3 will be compared to Visit 1 by treatment group; the results of treatment satisfaction questionnaires will be tabulated by treatment at Visit 3.
次要结局
未报告次要终点