NCT05378945已完成3 期
A Phase 3, Multicenter, Randomized, Controlled, Double-Masked Clinical Trial to Evaluate the Efficacy and Safety of OC-01 (Varenicline Solution) Nasal Spray on Signs and Symptoms of Dry Eye Disease in Chinese Population
Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.20 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2022年7月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 340
- 试验地点
- 20
- 主要终点
- Schirmer's Test Score
研究概览
简要总结
The objective of this study is to evaluate the safety and effectiveness of OC-01 (varenicline solution) Nasal Spray as compared to placebo (vehicle) on signs and symptoms of 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
- Double (Participant, Investigator)
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
- •Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to the Screening Visit
排除标准
- •Have had any intraocular surgery (such as cataract surgery) or extraocular surgery in either eye within three months or refractive surgery (e.g., laser-assisted in-situ keratomileusis, laser epithelial keratomileusis, photorefractive keratectomy or corneal implant) within 12 months of the Screening Visit
- •Have a history or presence of any ocular disorder or condition in either eye that would, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety such as significant corneal or conjunctival scarring; pterygium or nodular pinguecula; current ocular infection, acute conjunctivitis, or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring treatment and mild meibomian gland disease that are typically associated with DED are allowed.
- •Have a systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction or heart disease, etc.)
- •Have a known hypersensitivity to any of the procedural agents or investigational product components
- •Have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject.
研究组 & 干预措施
OC-01
Experimental
干预措施: Varenicline Tartrate Nasal Spray (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (vehicle) (Drug)
结局指标
主要结局
Schirmer's Test Score
时间窗: 28 days
Percentage of subjects who achieve ≥10 mm improvement in Schirmer's Test Score from baseline
次要结局
- Mean change from Baseline in Schirmer's Test Score (STS)(28 days)
- Mean change from Baseline in Eye Dryness Score (EDS)(28 days/ 14 days/ 7days)
研究者
研究点 (20)
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