A Phase 3, Prospective, Double-masked, Randomized, Multi-center, Vehicle-controlled, Parallel-group, 12-week Administration and 40-week Extension Study Confirming the Efficacy and Safety of K-161 Ophthalmic Solution for the Treatment of Moderate to Severe Dry Eye Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 644
- 试验地点
- 50
- 主要终点
- Change in EDS (VAS) From Baseline to Day 85
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of K-161 ophthalmic solution for the treatment of moderate to severe 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
- Quadruple (Participant, Care Provider, 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
- •Be at least 18 years of age at the time of Informed Consent
- •Have a reported history of dry eye disease in both eyes and a history of eye drop use for dry eye symptom
- •Meet all other inclusion criteria outlined in the clinical study protocol
排除标准
- •Have any clinically significant ocular condition
- •Have a history of corneal refractive surgery and/or any other ocular surgical procedure within 12 months
- •Meet any other exclusion criteria outlined in the clinical study protocol
研究组 & 干预措施
Placebo
Vehicle Solution
干预措施: Placebo (Drug)
K-161
K-161 Ophthalmic Solution
干预措施: K-161 (Drug)
结局指标
主要结局
Change in EDS (VAS) From Baseline to Day 85
时间窗: Baseline to Day 85
* Eye Dryness Score (EDS) on Visual analog scale (VAS) * Participant self rated level of severity where, 0 mm corresponds to "None" and 100 mm corresponds to "Worst Possible".
Change in Conjunctival Sum Fluorescein Staining Score From Baseline to Day 85 (Study Eye)
时间窗: Baseline to Day 85
* Assessed by expanded National Eye Institute (NEI) scale * Conjunctival sum will be assessed as the sum of points in 6 conjunctival zones, and each zone will be graded on a 5-point scale from 0 - no conjunctival staining to 4 - severe staining of the area (0.5 increments would be allowed) * Minimum is 0 and maximum is 24 for Conjunctival Sum Fluorescein Staining Score.
次要结局
- Change From Baseline to Day 85 in Schirmer's Test (Unanesthetized) (Study Eye)(Baseline to Day 85)
- Change From Baseline to Day 85 in Tear Film Break-up Time (TFBUT) (Study Eye)(Baseline to Day 85)
- Change From Baseline to Day 85 in Total Eye Sum Fluorescein Staining Score (Study Eye)(Baseline to Day 85)
- Change From Baseline to Day 85 in Corneal Sum Fluorescein Staining Score (Study Eye)(Baseline to Day 85)
- Change From Baseline to Day 85 in Ocular Surface Disease Index Score (OSDI©)(Baseline to Day 85)