NCT06296966招募中2 期
A Four-Week, Double-Masked, Randomized, Placebo-Controlled, Phase 2, Evaluation of the Safety and Efficacy of VSJ-110 Ophthalmic Solution in the Treatment of Dry Eye
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Schirmer's Tear Test
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of VSJ-110 compared to placebo in the treatment of dry eye.
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 of either gender and any race.
- •Provide written informed consent and sign the HIPAA form.
- •Be willing and able to follow all instructions and attend all study visits.
排除标准
- •Use of any of the disallowed medications during the washout and study period.
研究组 & 干预措施
VSJ-110 Solution
Experimental
干预措施: VSJ-110 (Drug)
Placebo Solution
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Schirmer's Tear Test
时间窗: Measured over a 4-week treatment period
Schirmer's Tear Test strips are used to measure ocular fluid.
次要结局
- Ocular Staining(Measured over a 4-week treatment period)
- Eye Dryness Score (EDS) of the Visual Analogue Scale (VAS)(Measured over a 4-week treatment period)
研究者
研究点 (1)
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