Systane Complete Multi-symptom Relief
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 8
- 主要终点
- Change from Baseline at Day 28 in IDEEL-SB Question "Stinging"
研究概览
简要总结
The purpose of this study is to demonstrate effective symptom relief with the use of Systane Complete among subjects with dry eye disease (DED).
详细描述
Subjects will be expected to attend a screening/baseline visit and one additional visit at Day 28 (± 2 days), with a telephone call visit conducted at Day 14 (± 2 days). Individual duration of subject participation will be approximately 28 days.
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
- 否
入选标准
- •Able to understand and sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form.
- •Willing and able to attend all study visits as required per protocol.
- •Have dry eye symptoms as specified in the protocol.
- •Willing to discontinue use of all habitual artificial tear supplements for the entire study duration.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Ocular conditions as specified in the protocol.
- •Contact lens use within one week prior to screening visit.
- •Use of medications as specified in the protocol.
- •Pregnant or breast feeding.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Change from Baseline at Day 28 in IDEEL-SB Question "Stinging"
时间窗: Baseline (Day 0), Day 28
Subjects will respond to the question, "OVER THE LAST TWO WEEKS, how much did the following symptom bother you: Stinging Eyes?" using a 0-4 Likert-type scale, where 0 = "I did not have this symptom/Not applicable" and 4 = Very Much. A negative change value will represent perceived improvement.
Change from Baseline at Day 28 in IDEEL-SB Question "Burning"
时间窗: Baseline (Day 0), Day 28
Subjects will respond to the question, "OVER THE LAST TWO WEEKS, how much did the following symptom bother you: Burning Eyes?" using a 0-4 Likert-type scale, where 0 = "I did not have this symptom/Not applicable" and 4 = Very Much. A negative change value will represent perceived improvement.
Change from Baseline at Day 28 in IDEEL-SB Question "Tired Eyes"
时间窗: Baseline (Day 0), Day 28
Subjects will respond to the question, "OVER THE LAST TWO WEEKS, how much did the following symptom bother you: Tired Eyes?" using a 0-4 Likert-type scale, where 0 = "I did not have this symptom/Not applicable" and 4 = Very Much. A negative change value will represent perceived improvement.
Change from Baseline at Day 28 in IDEEL-SB Question "Sore"
时间窗: Baseline (Day 0), Day 28
The Impact of Dry Eye on Everyday Life - Symptoms Bother (IDEEL-SB) is a patient-reported outcome measures questionnaire designed to assess symptoms of dry eye disease. Subjects will respond to the question, "OVER THE LAST TWO WEEKS, how much did the following symptom bother you: Sore Eyes?" using a 0-4 Likert-type scale, where 0 = "I did not have this symptom/Not applicable" and 4 = Very Much. A negative change value will represent perceived improvement.
Change from Baseline at Day 28 in DEQ-5 Question "Watery"
时间窗: Baseline (Day 0), Day 28
The Dry Eye Questionnaire-5 (DEQ-5) is a patient-reported outcome measures questionnaire designed to assess symptoms of dry eye disease. Subjects will respond to the question, "During a typical day in the past month, how often did your eyes look or feel excessively watery?" using a 0-4 Likert-type scale, where 0 = Never and 4 = Constantly. A negative change value will represent perceived improvement.
次要结局
未报告次要终点