NCT07179055招募中2 期
An Eight-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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Corneal Staining
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
Corneal Staining
时间窗: Measured over an 8-week treatment period
Corneal Staining will be assessed by the investigator on a scale of 0-4, with a higher number indicating a higher grade of staining.
次要结局
- Schirmer's Tear Test(Measured over an 8-week treatment period)
- Eye Dryness Score (EDS) of the Visual Analogue Scale (VAS)(Measured over an 8-week treatment period)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
2 期
A Study to Evaluate the Safety and Efficacy of VSJ-110 Compared to Placebo in the Treatment of Dry EyeDry EyeNCT06296966Vanda Pharmaceuticals40
已完成
2 期
Safety and Efficacy of VSJ-110 in the Treatment of Allergic Conjunctivitis in Adults With a History of Ocular AllergiesAllergic ConjunctivitisNCT04622345Vanda Pharmaceuticals47
已完成
2 期
A Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Cancer-related PainPain, BurningPain, CrushingPain, MigratoryPain, RadiatingPain, SplittingNCT00929188Janssen Research & Development, LLC100
已完成
3 期
JT001 (VV116) for the Treatment of COVID-19Mild to Moderate COVID-19NCT05582629Shanghai Vinnerna Biosciences Co., Ltd.1,369
已完成
2 期
A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum DisorderAutism Spectrum DisorderNCT03664232Janssen Research & Development, LLC78