Clinical Evaluation Following Use of SYSTANE® BALANCE in Subjects With Lipid-Deficient Dry Eye
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 308
- 主要终点
- Mean Change From Baseline in Tear Film Break-Up Time (TFBUT) at Day 35
研究概览
简要总结
The purpose of this study is to evaluate the clinical effectiveness of SYSTANE® BALANCE compared to REFRESH OPTIVE® Advanced in subjects with lipid-deficient dry eye.
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
- •Willing and able to attend all study visits;
- •Must sign an informed consent form;
- •Best-corrected visual acuity (BCVA) of 55 letters or better in each eye as assessed using an early treatment diabetic retinopathy study (ETDRS) chart;
- •Willing to take study products as directed for entire study;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Women of childbearing potential who are pregnant, plan to become pregnant during the study, breast feeding, or not using adequate birth control methods;
- •Contact lens use within 30 days prior to Screening Visit, or unwilling to avoid contact lens use during the course of the study;
- •Use of medication excluded by the protocol;
- •Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol;
- •Ocular surgeries or procedures excluded by the protocol;
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
REFRESH OPTIVE
Lubricant eye drops, 1 drop in each eye 4 times per day for 35 days
干预措施: Lubricant eye drops (Other)
SYSTANE BALANCE
Propylene glycol, 0.6% eye drops, 1 drop in each eye 4 times per day for 35 days
干预措施: Propylene glycol, 0.6% eye drops (Other)
结局指标
主要结局
Mean Change From Baseline in Tear Film Break-Up Time (TFBUT) at Day 35
时间窗: Baseline (Day 0), Day 35
TFBUT (the time required for dry spots to appear on the surface of the eye after blinking) was assessed with a fluorescein strip and measured in seconds. Using a stopwatch, the investigator measured the time from the last blink until one or more black (dry) spots appeared in the precorneal tear film. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement. Only one eye (analysis eye) contributed to the analysis.
次要结局
- Change From Baseline in TFBUT at Day 35(Baseline (Day 0), Day 35)
- Lipid Layer Thickness (LLT) Area Under the Curve (AUC120) at Day 35(Day 35)
- Mean Change From Baseline in Global Ocular Discomfort Visual Analog Scale (VAS) Score at Day 35(Baseline (Day 0), Day 35)