Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 主要终点
- Mean Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 35 (Phase I)
研究概览
简要总结
The purpose of this study is to compare Systane® ULTRA lubricant eye drops to OPTIVE® lubricating eye drops for ocular surface staining within dry eye subjects and to evaluate the safety of Systane® ULTRA after 3 months of use.
详细描述
Following a 2-week washout phase with saline eye drops, subjects were randomized to receive either Systane® ULTRA or OPTIVE® for the remainder of the study.
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
- Single (Outcomes Assessor)
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.
- •Diagnosis of dry eye, as specified in protocol.
- •Uses artificial tears, as specified in protocol.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Poor visual acuity, as specified in protocol.
- •Women of childbearing potential who are pregnant, lactating, or not using adequate birth control, as specified in protocol.
- •Any hypersensitivity or allergy to the investigational products or ingredients.
- •Any eye disorder, ocular surgery, medication, medical condition, or systemic disease, as specified in protocol.
- •Contact lens use within 2 weeks of Screening Visit.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Mean Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 35 (Phase I)
时间窗: Baseline, Day 35
The TOSS score is a composite score of corneal fluorescein staining, nasal conjunctival lissamine green staining, and temporal conjunctival lissamine green staining, each scored on a 0-5 Likert scale (0=absent, 5=severe). TOSS scores can range from 0 to 15. One eye (study eye) contributed to the analysis.
次要结局
- Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Effectiveness Score at Day 35 (Phase I)(Day 35)
- Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Inconvenience Score at Day 35 (Phase I)(Day 35)
- Mean Ocular Surface Disease Index (OSDI) Score at Day 35 (Phase I)(Day 35)