Clinical Evaluation of Systane® Balance on Corneal Staining in Indian Subjects With Dry Eye
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 主要终点
- Change From Baseline in Corneal Staining Total Score
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Systane® Balance following 90 days of QID (4 times/day) dosing among Indian subjects with dry eye.
详细描述
This study was conducted in India.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign informed consent and willing and able to attend all study visits;
- •Dry eye in both eyes diagnosed by an ophthalmologist;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Women of childbearing potential who are pregnant or breastfeeding;
- •Any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in the study;
- •Ocular surgery or ocular trauma requiring medical or pharmacological treatment within 1 year of Screening;
- •Use of topical ocular prescription or non-prescription medications, RESTASIS or topical ocular steroids within 14 days of Screening;
- •Use of any artificial tears/gels/lubricants/rewetting drops within 4 hours of Screening;
- •Contact lens wear within 1 week of Screening and/or unwillingness to discontinue contact lens wear for the duration of the study;
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
Systane Balance
Propylene Glycol 0.6% eye drops, 1 drop QID (with the last dose of each day at bedtime) in each eye for 90 days
干预措施: Propylene Glycol 0.6% eye drops (Other)
结局指标
主要结局
Change From Baseline in Corneal Staining Total Score
时间窗: Baseline (Day 0), Day 45, Day 90
The type (severity) of staining was assessed for each of the 5 regions of the cornea (central, inferior, temporal, superior, and nasal) and graded on a 4-point scale, where 0 = Normal (No staining) and 3 = Severe (Numerous coalescent macropunctate areas and/or patches). The scores of the 5 regions were summed to obtain a corneal staining total score for each eye (minimum 0, maximum 15).
次要结局
未报告次要终点