Systane® Hydration PF and Systane® Hydration Preserved
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 137
- 试验地点
- 6
- 主要终点
- Resultant overall CLDEQ-8 score - Group 2 and Group 3
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 Hydration Preservative Free (PF) in subjects experiencing dry eye symptoms (Group 1) and in contact lens (CL) wearers experiencing discomfort due to CL-related dryness (Group 2) and also Systane Hydration Preserved in CL wearers experiencing discomfort due to CL-related dryness (Group 3). Statistical analyses will be presented by group.
详细描述
Subjects will participate in the study for approximately 30 days, with 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 patient questionnaires on Day 1 and at Visit 3 (Impact of Dry Eye on Everyday Life - Symptom Bother [IDEEL-SB] or Contact Lens Dry Eye Questionnaire [CLDEQ-8] and Comfortable Wear Time questions).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Subject must be able to understand and sign an informed consent form
- •Subject with mild to moderate dry eye
- •Subject with CL-related dry eye symptoms
- •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
Resultant overall CLDEQ-8 score - Group 2 and Group 3
时间窗: Visit 3 (Day 30)
The CLDEQ-8 is an eight-item questionnaire that evaluates the severity of dry eye symptoms in soft contact lens wearers within the past 2 weeks. Each question is answered using a 0-4, 0-5, or 1-6 Likert scale for a resultant overall score of 1-37. No statistical hypothesis is pre-specified for this endpoint.
Mean overall IDEEL-Symptom Bother(SB) score - Group 1
时间窗: Visit 3 (Day 30)
The IDEEL-SB (Version 1) symptom bother module consists of 20 questions that assess general dry eye symptoms a subject experiences. The subject will be instructed to select a single response that best represents their answer. The Symptom Bother score is calculated as the mean value of the non-missing item scores 1-20 multiplied by 25. No statistical hypothesis is pre-specified for this endpoint.
次要结局
未报告次要终点