NCT01636206已完成3 期
A Phase 3, Multicenter, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Safety of a 5.0% Concentration of Lifitegrast Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye (SONATA)
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
- Shire
- 入组人数
- 332
- 试验地点
- 1
- 主要终点
- Number of Participants With Ocular and Nonocular Treatment Emergent Adverse Events (TEAEs) for 1 Year
研究概览
简要总结
The purpose of the study is to evaluate the safety of lifitegrast ophthalmic solution compared to placebo in the treatment of dry eye as assessed by ocular and non-ocular adverse events when administered BID for approximately 1 year.
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
- •Willing and able to read, sign and date the informed consent and HIPAA documents
- •Willing and able to comply with all study procedures
- •Be at least 18 years of age
- •Patient-reported history of dry eye in both eyes
- •A negative urine pregnancy test if female of childbearing potential and must use adequate birth control throughout the study period
排除标准
- •Any ocular condition that, in the opinion of the Investigator, could affect study parameters including, but not limited to, active ocular infection, ocular inflammation, glaucoma, and/or diabetic retinopathy
- •Unwilling to avoid wearing contact lenses for 24h prior to Visit 1 and for some duration during the study
- •Any blood donation or significant loss of blood within 56 days of Visit 1
- •Any history of immunodeficiency disorder, positive HIV, hepatitis B, C, or evidence of acute active hepatitis A (anti-HAV IgM), or organ or bone marrow transplant.
- •Use of any prohibited medications during the appropriate pre-study washout period and at any time during the study unless otherwise specified
- •Any significant illness that could interfere with study parameters
- •History of laser-assisted in situ keratomileusis (LASIK) or similar type of corneal refractive surgery within 12 months prior to Visit 1, and/or any other ocular surgical procedure within 12 months prior to Visit 1; or any scheduled ocular surgical procedure during the study period.
- •Known history of alcohol and/or drug abuse
- •Subjects with Dry eye secondary to scarring or destruction of conjunctival goblet cells (as with Vitamin A deficiency)
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
Lifitegrast
Experimental
Active
干预措施: Lifitegrast (Drug)
结局指标
主要结局
Number of Participants With Ocular and Nonocular Treatment Emergent Adverse Events (TEAEs) for 1 Year
时间窗: Day 0 to Day 360
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Phase 3 Study to Evaluate the Efficacy of Lifitegrast in Subjects With Dry EyeDry Eye DiseaseNCT01743729Shire720
已完成
早期 1 期
The Effects and Safety of 5% Lifitegrast Ophthalmic Solution in Subjects With Dry Eye Disease in Ocular Graft-versus-Host DiseaseGraft-versus-host-diseaseOcular Graft-versus-host DiseaseNCT04792580Richard W Yee, MD30
已完成
3 期
A Study to Evaluate Efficacy and Safety of Lifitegrast in Subjects With Dry Eye (OPUS-3)Dry Eye DiseaseNCT02284516Shire711
已完成
3 期
A Study to Assess Efficacy and Safety of HL036 in Subjects With Dry EyesDry EyeNCT03846453HanAll BioPharma Co., Ltd.637
已完成
2 期
To Assess the Safety and Efficacy of R932348 Ophthalmic Solutions in Patients With Keratoconjunctivitis SiccaKeratoconjunctivitis SiccaNCT01900249Rigel Pharmaceuticals204