Systane Hydration in Subjects Undergoing Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Corneal staining
研究概览
简要总结
The primary objective of this study is to demonstrate reduced corneal staining with use of Systane Hydration among subjects with dry eye disease (DED) undergoing routine cataract removal and monofocal intraocular lens (IOL) implantation.
详细描述
Subjects will attend 6 scheduled study visits for an individual duration of participation of 6 weeks. One eye (study eye) will be followed.
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 (Investigator, 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
- •Seeking routine (age-related) cataract extraction with monofocal intraocular lens implantation;
- •Able to provide informed consent;
- •Willing and able to attend all study visits and comply with treatment;
- •Have dry eyes per dry eye questionnaire.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Subjects who use of ocular drugs, other than the test article (for treatment group only) and other standard of care postoperative medications, during the study;
- •History of intraocular or corneal surgery in the study eye;
- •Use of artificial tears, steroids, or other medications as specified in the protocol;
- •Clinically significant corneal scarring;
- •Corneal degeneration, retinal degeneration or other ocular pathology as specified in the protocol.
- •Other protocol-specified exclusion criteria may apply.
结局指标
主要结局
Corneal staining
时间窗: Up to Day 30 post-operative
The National Eye Institute (NEI) grading scale will be used to evaluate the five corneal regions: Superior, inferior, central, temporal and nasal. Each region will be graded on a 0-3 scale, where 0 = normal (no staining), 1 = mild/superficial stippling micropunctate staining, 2 = moderate/macropunctate staining with some coalescent areas, and 3 = severe/numerous coalescent macropunctate areas and/or patches. The regions will be summed for a resultant overall score of 0 to 15.
次要结局
- DEQ-5 Score(Up to Day 30 post-operative)
- Ocular Comfort Questionnaire Score: My eyes are comfortable(Up to Day 30 post-operative)
- Ocular Comfort Questionnaire Score: At the end of the day, my eyes feel comfortable(Up to Day 30 post-operative)
- Ocular Comfort Questionnaire Score: My eyes are comfortable all day long(Up to Day 30 post-operative)