A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled Clinical Trial Evaluating the Safety, Tolerability, and Efficacy of A197 in Subjects With Dry Eye Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 24
- 主要终点
- Change from baseline in total corneal fluorescein staining (CFS)
研究概览
简要总结
The objectives of this trial are to assess the safety, tolerability and efficacy of A197 ophthalmic solution in comparison to a vehicle control in the treatment of subjects 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
- •Written informed consent must be obtained prior to any study-related assessments
- •Have a history of Dry Eye Disease in both eyes for at least 12 months prior to Visit 1
- •Willing and able to follow instructions and can be present for required study visits
排除标准
- •Women who are pregnant or breastfeeding
- •Use of topical ophthalmic medications, artificial tears, eye drops and gels in either eye
- •Use of contact lenses within 90 days prior to Visit 1 and throughout the study
- •Have had an ocular infection in either eye within 90 days prior to Visit 1
研究组 & 干预措施
A197 Ophthalmic Solution, Low Dose
干预措施: A197 Ophthalmic Solution (Drug)
A197 Ophthalmic Solution, High Dose
干预措施: A197 Ophthalmic Solution (Drug)
A197 Vehicle Control
干预措施: A197 Vehicle Control (Drug)
Active Comparator
干预措施: Active Comparator (Drug)
结局指标
主要结局
Change from baseline in total corneal fluorescein staining (CFS)
时间窗: 12 Weeks
Corneal Fluorescein Staining (tCFS) is graded based on a modified National Eye Institute (NEI) scale. The NEI scale divides the cornea in 5 regions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-4 using 0.5 unit increments; 0 corresponds to no staining, 4 corresponds to maximum staining. The total score is the sum of the 5 regions ranging from 0-20.
次要结局
- Change from baseline in bulbar conjunctival hyperemia (CCLRU)(12 Weeks)
- Change from baseline in eye dryness via the Visual Analogue Scale (VAS)(12 Weeks)
- Change from baseline in lissamine green conjunctival staining (LGCS)(12 Weeks)