A Study Assessing the Safety, Efficacy, and Optimum Dosage of K-161 in Subjects With Moderate to Severe Dry Eye Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 238
- 试验地点
- 4
- 主要终点
- Change in Inferior Corneal Fluorescein Staining Score Post Controlled Adverse Environment (Post-Controlled Adverse Environment (CAE))
研究概览
简要总结
The objective of the study is to assess the safety, efficacy, optimum dosage, and dosing regimen of K-161 in adult subjects with 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 visit.
- •Have a reported history of dry eye disease in both eyes and a history of eye drop use for dry eye symptoms.
- •Meet all 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.
- •Must not meet any other exclusion criteria outlined in the clinical study protocol.
研究组 & 干预措施
Group 1
K-161 Ophthalmic Solution Dose A.
干预措施: K-161 (Drug)
Group 2
K-161 Ophthalmic Solution Dose B.
干预措施: K-161 (Drug)
Group 3
K-161 Ophthalmic Solution Dose C.
干预措施: K-161 (Drug)
Group 4
Vehicle Solution Dose.
干预措施: Placebo (Vehicle) (Other)
结局指标
主要结局
Change in Inferior Corneal Fluorescein Staining Score Post Controlled Adverse Environment (Post-Controlled Adverse Environment (CAE))
时间窗: Baseline to Day 29
Fluorescein Staining is measured with the Ora Calibra® Corneal and Conjunctival Staining Scale which is a 0 to 4 scale with increasing half-units and where higher numbers indicating more severe staining. K-161 compared to Vehicle. When study patients are exposed to Controlled Adverse Environment (CAE) in terms of relative humidity, temperature, airflow, and visual tasking, the ocular surface is stressed to react. This controlled environmental stress creates a consistent response that's reproducible over time.
Change in Ocular Discomfort Scale Post-CAE
时间窗: Baseline to Day 29
Ocular discomfort scores were subjectively graded by the subjects using the Ora Calibra® Ocular Discomfort Scale from 0 to 4 where 0 = No Discomfort and 4 = Constant Discomfort.
次要结局
- Change in Lissamine Green Staining (Pre-CAE) Using the Ora Calibra® Scale (Conjunctival Sum)(Baseline to Day 29)
- Change in Tear Film Break-Up Time (Pre CAE)(Baseline to Day 29)
- Change in Tear Osmolarity (Pre CAE)(Baseline to Day 29)
- Change in Unanesthetized Schirmer's Test (Pre CAE)(Baseline to Day 29)
- Change in Ocular Discomfort Scale (Pre CAE)(Baseline to Day 29)
- Change in Schirmer's Test Value (Unanesthetized) Pre-CAE(Baseline to Day 29)
- Change in Conjunctival Redness (Pre-CAE)(Baseline to Day 29)
- Change in Blink Rate (Pre CAE)(Baseline to Day 29)
- Change in Tear Film Break-up Time (TFBUT) Post-CAE(Baseline to Day 29)
- Change in Fluorescein Staining Scores (Pre-CAE®)(Baseline to Day 29)
- Change in Ocular Discomfort and 4-Symptom Questionnaire (Pre CAE)(Baseline to Day 29)
- Change in Visual Analog Scale (Pre CAE)(Baseline to Day 29)
- Change in Ocular Surface Disease Index Score (Pre-CAE) - Total OSDI(Baseline to Day 29)