A Phase II, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of OT202 Eye Drops in the Treatment of Moderate to Severe Dry Eye
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 213
- 试验地点
- 10
- 主要终点
- Total Corneal Fluorescein Staining (TCSS) score
研究概览
简要总结
This is a phase II study to explore the optimal dosage of OT202 in treating dry eye.
详细描述
Subjects successfully enrolled will enter a 2-week induction period of OT202 solvent eye drops, treated with OT202 three times daily (morning, afternoon, and evening), with 1-2 drops each time. On the day of the baseline visit (Visit 2), subjects will be assessed again to meet the inclusion and exclusion criteria. Subjects remain in the study are then randomized with a 1:1:1 ratio to 3 groups, the 0.5% OT202 eye drop group, 1% OT202 eye drop group, or OT202 solvent eye drop group, for an 8-week treatment period. Safety visits will be conducted 2 weeks after completion of the respective treatment.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
OT202 conc.0.5% group
Administered three times daily (morning, afternoon, and evening), with 1-2 drops each time, instilled into the conjunctival sac.
干预措施: OT202 conc 0.5% (Drug)
OT202 conc. 0.1% group
Administered three times daily (morning, afternoon, and evening), with 1-2 drops each time, instilled into the conjunctival sac.
干预措施: OT202 conc 0.1% (Drug)
Placebo group
Administered three times daily (morning, afternoon, and evening), with 1-2 drops each time, instilled into the conjunctival sac.
干预措施: Placebo (Drug)
结局指标
主要结局
Total Corneal Fluorescein Staining (TCSS) score
时间窗: Day 56
Compare the difference of changes in TCSS relative to baseline of three study groups on day 56.
次要结局
- Tear Film Breakup-time (TFBUT)(Day 28 & 56)
- Schirmer I Test(Day 28 & 56)
- Ocular Surface Disease Index (OSDI) Score(Day 28 & 56)
- Visual Analogue Scale (VAS) Score(DAY 28 & 56)
- Conjunctive Hyperemia(Day 28 & 56)
- Corneal Staining(Day 28 & 56)
- A dry eye syndrome questionnaire - Symptom Assessment iN Dry Eye(SANDE)(Day 28 & 56)