Evaluation of the Clinical Efficacy and Tolerability of SYSTANE Complete in Adult Patients With Dry Eye Disease Following Topical Ocular Use for 4 Weeks: A Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 6
- 主要终点
- Change from baseline in Tear Film Break-up Time (TFBUT) at Day 14
研究概览
简要总结
The purpose of this study is to evaluate the clinical effectiveness and tolerability of SYSTANE® Complete in adult patients with dry eye disease. Fluorescein-stained tear film break-up time (TFBUT) will be evaluated as the primary objective.
详细描述
Patients will attend 4 scheduled visits: Screening Visit (Day -7 to Day 0), Visit 1/Baseline Visit (Day 1), Visit 2 (Day 14) and Visit 3 (Day 28).
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
- •Must have TFBUT of ≤ 5 seconds in at least one eye at Screening visit.
- •Must have best corrected visual acuity (BCVA) of ≥ 20/80 (or ≥ 55 letters score or ≥ 0.6 early treatment diabetic retinopathy study (ETDRS) log of the minimum angle of resolution (LogMAR) value) in both eyes at the Screening visit.
- •Must be willing to discontinue use of all artificial tear supplements and use only the study product as directed for the entire study duration.
排除标准
- •History of hypersensitivity to the study drug or any of its excipients or to drugs of similar chemical classes.
- •Use of any topical ocular medication preserved with benzalkonium chloride or other products known to be toxic to the tear film lipid layer within 1 month prior to the Screening visit.
- •Other protocol-specified inclusion and exclusion criteria may apply.
研究组 & 干预措施
SYSTANE Complete
Propylene glycol-based eye drops, 1 drop in each eye twice a day (BID) (morning and evening) for 28 days. Patients can administer additional doses in between the scheduled daily doses as needed
干预措施: Propylene glycol-based eye drops (Other)
结局指标
主要结局
Change from baseline in Tear Film Break-up Time (TFBUT) at Day 14
时间窗: Baseline, Day 14
TFBUT will be assessed using fluorescein, an ocular staining dye
次要结局
- Change from baseline in ocular discomfort at Day 14(Baseline, Day 14)
- Change from baseline in EQ-5D-5L score(s) at Day 28(Baseline, Day 28)
- Tolerability assessment score(Day 1)
- Change from baseline in TFBUT at Day 28(Baseline, Day 28)
- Change from baseline in corneal staining score at Day 28(Baseline, Day 28)
- Change from baseline in dry eye symptom score at Day 1(Baseline, Day 1)
- Soothing sensation score(Day 1)
- Change from baseline in response to the revised IDEEL questionnaire at Day 28(Baseline, Day 28)