Systane® Complete Preservative Free Lubricant Eye Drops
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 8
- 主要终点
- Mean Overall Impact of Dry Eye on Everyday Life Symptom Bother (IDEEL SB) Score - By Dry Eye Group
研究概览
简要总结
The purpose of this post-market clinical follow-up (PMCF) study is to assess the performance and safety of Systane Complete Preservative Free (PF) lubricant eye drops in subjects experiencing dry eye symptoms. Statistical analyses will be presented overall and by Dry Eye Disease (DED) group.
详细描述
Subjects will participate in the study for approximately 30 days, with a Screening/Baseline visit scheduled on Day 1, a phone call scheduled on Day 15 ± 2 (Visit 2) and a follow-up visit scheduled on Day 30 ± 2 (Visit 3). Subjects will be asked to complete the Impact of Dry Eye on Everyday Life - Symptom Bother [IDEEL-SB]) questionnaire on Day 1 and Visit 3. In addition, subjects will be instructed to document Systane Complete PF dosing information on a daily basis using a subject diary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subject must be able to understand and sign an informed consent form
- •Subject with mild to moderate dry eye
- •Other protocol-defined inclusion criteria may apply
排除标准
- •Has suffered any ocular injury to either eye in the past 3 months prior to screening.
- •Has undergone any other ocular surgery (including intraocular surgery) within the past 6 months or has any ocular surgery planned during the study.
- •Other protocol-defined exclusion criteria may apply
结局指标
主要结局
Mean Overall Impact of Dry Eye on Everyday Life Symptom Bother (IDEEL SB) Score - By Dry Eye Group
时间窗: Baseline (Day 1 pretreatment), Day 30
The IDEEL SB module is a 20-question, patient-reported outcome questionnaire that assesses the subject's symptoms of dry eye. For each question, the subject selected a single response for both eyes, where 0="None of the time" (Q1) or "I did not have this symptom/Not Applicable" (Q2-20) to 4="All of the time" (Q1) or "Very Much" (Q2-20). The overall Symptom Bother score was calculated as the mean value of the non-missing item scores (Q1-20) multiplied by 25, for an overall resultant score ranging from 0 to 100. Higher scores indicate greater symptom bother. No statistical hypothesis was pre-specified for this endpoint.
Mean Overall Impact of Dry Eye on Everyday Life Symptom Bother (IDEEL SB) Score - All Subjects
时间窗: Baseline (Day 1 pretreatment), Day 30
The IDEEL SB module is a 20-question, patient-reported outcome questionnaire that assesses the subject's symptoms of dry eye. For each question, the subject selected a single response for both eyes, where 0="None of the time" (Q1) or "I did not have this symptom/Not Applicable" (Q2-20) to 4="All of the time" (Q1) or "Very Much" (Q2-20). The overall Symptom Bother score was calculated as the mean value of the non-missing item scores (Q1-20) multiplied by 25, for an overall resultant score ranging from 0 to 100. Higher scores indicate greater symptom bother. No statistical hypothesis was pre-specified for this endpoint.
次要结局
未报告次要终点