A Safety and Efficacy Study of Refresh Optive® Gel Drops in Patients With Dry Eye Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 188
- 试验地点
- 10
- 主要终点
- Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score
研究概览
简要总结
This study will evaluate the safety and efficacy o fRefresh Optive® Gel Drops in patients with dry eye disease.
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
- •Current use of an artificial tear product
- •Visual acuity of at least 20/32 (while wearing glasses, if necessary).
排除标准
- •Use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study
- •Cataract surgery, laser-assisted in situ keratomileusis [LASIK], or photorefractive keratectomy, within the last 6 months
- •Current eye infection or inflammation
研究组 & 干预措施
Refresh Optive® Gel Drops
Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
干预措施: Refresh Optive® Gel Drops (Drug)
REFRESH LIQUIGEL®
REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
干预措施: REFRESH LIQUIGEL® (Drug)
结局指标
主要结局
Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score
时间窗: Baseline, Day 30
The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.
次要结局
- Change From Baseline in the OSDI© Score(Baseline, Day 7)
- Change From Baseline in the Combined Corneal and Conjunctival Staining Scores(Baseline, Day 30)
- Change From Baseline in the Schirmer Test(Baseline, Day 30)
- Change From Baseline in Tear Break-up Time (TBUT)(Baseline, Day 30)