Clinical Evaluation of Systane® Gel Drops on Corneal Staining in Indian Subjects With Dry Eye
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 2
- 主要终点
- Change From Baseline in Corneal Staining at All Study Time Points
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Systane® Gel Drops in dry eye subjects following 90 days of QID (4 times/day) dosing.
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
- •Must give informed consent, and be willing and able to attend all study visits.
- •Best-corrected visual acuity (BCVA) of ≥ 55 letters in each eye as measured by ETDRS (letters read method).
- •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, test positive on a pregnancy test, or breast-feeding.
- •Any medical condition (systemic or ophthalmic) that may, in the opinion of the Investigator, preclude the safe administration of test article or safe participation in the study.
- •Any contraindications or hypersensitivities to the study medications or their components.
- •Ocular surgery (of any type, including PRK, LASIK, Epilasik, etc.) 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.
- •Chronic medications (over the counter, prescription, or vitamins) that have not been on a stable dose for at least 30 days prior to Screening.
- •Contact lens wear within 1 week of Screening and/or unwillingness to discontinue contact lens wear for the duration of the study.
- •Participation in any other clinical trial within 30 days prior to Screening.
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
Systane
Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops, 1 drop QID in each eye for 90 days
干预措施: Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops (Other)
结局指标
主要结局
Change From Baseline in Corneal Staining at All Study Time Points
时间窗: Baseline (Day 0), Day 45, Day 90
Corneal staining was assessed by the Investigator through slit-lamp examination and reported on a scale of 0-3, where 0=normal (no staining) and 3=severe (numerous coalescent macropunctate areas and/or patches), for the 5 quadrants of each eye. The scores at each visit were summed by eye for each subject. The overall corneal staining score for the subject at each visit was then computed as the average of the sum from both eyes. Thus, the overall scores ranged between 0-15 with higher scores reflecting more damage to the corneal surface.
次要结局
未报告次要终点