A Safety and Efficacy Study of Tavilermide Ophthalmic Solution for the Treatment of Dry Eye Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Ocular Discomfort Using The Ora Calibra Scale
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of Tavilermide Ophthalmic Solution compared with Placebo Ophthalmic Solution in treating the 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
- 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.
- •Provided written informed consent.
- •Have a reported history of dry eye Have a history of use or desire to use eye drops for dry eye
排除标准
- •Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal) at Visit
- •Be diagnosed with ocular rosacea, or any viral or bacterial disease of the cornea or conjunctiva, within the last 12 months.
- •Have any planned ocular and/or lid surgeries over the study period.
- •Have corrected visual acuity greater than or equal to +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at Visit .
- •Have an uncontrolled systemic disease.
- •Be a woman who is pregnant, nursing or planning a pregnancy.
- •Be a woman of childbearing potential who is not using an acceptable means of birth control
- •Have a known allergy and/or sensitivity to the test article or its components.
- •Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
- •Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 45 days of Visit 1 Be unable or unwilling to follow instructions, including participation in all study assessments and visits
研究组 & 干预措施
Tavilermide Ophthalmic Solution
1% Tavilermide Ophthalmic Solution
干预措施: 1% Tavilermide Ophthalmic Solution (Drug)
Vehicle Ophthalmic Solution
Placebo Ophthalmic Solution
干预措施: Placebo Ophthalmic Solution (Drug)
结局指标
主要结局
Ocular Discomfort Using The Ora Calibra Scale
时间窗: Day 57
A patient-reported subjective assessment of ocular discomfort recorded at each of the 5 office visits throughout the treatment period
Total Corneal Fluorescein Staining Using The Ora Calibra Scale
时间窗: Day 57
An assessment of the total corneal fluorescein staining using the Ora Calibra Scale both immediately prior to and immediately following exposure to a challenge in a controlled adverse environment (CAE)
次要结局
- Total Corneal Fluorescein Staining Using The Ora Calibra Scale(Day 15)
- Ocular Surface Disease Index(Day 57)
- Ocular Dryness Using The Ora Calibra Scale(8 weeks)