A Phase 3, Multicenter, Randomized, Double-Masked, Vehicle-Controlled Clinical Study to Assess the Efficacy and Safety of 5% Tavilermide Ophthalmic Solution for the Treatment of Dry Eye
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 642
- 试验地点
- 29
- 主要终点
- Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale
研究概览
简要总结
The purpose of the study is to compare the efficacy and safety of 5% tavilermide ophthalmic solution to placebo for the treatment of 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
- •Subject-reported history of dry eye disease in both eyes for at least 6 months;
- •History of use of artificial tear eye drops for dry eye symptoms;
- •Total score of ≥40 on SANDE;
- •Corneal fluorescein staining;
- •Lissamine green conjunctival staining;
- •Schirmer's test score.
排除标准
- •Have participated in a previous tavilermide (MIM-D3) study;
- •Have clinically significant slit lamp findings at Visit 1;
- •Have a history of lacrimal duct obstruction within 12 months of Visit 1;
- •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 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 prior to Visit 1.
研究组 & 干预措施
5% Tavilermide ophthalmic solution
干预措施: 5% Tavilermide ophthalmic solution (Drug)
Vehicle ophthalmic solution
干预措施: Vehicle ophthalmic solution (Other)
结局指标
主要结局
Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale
时间窗: Baseline to Day 85
The National Eye Institute (NEI) scale is a standardized grading system of 0-3 was used for each of the 5 areas on each cornea (central, superior, temporal, nasal, and inferior). Grade 0 was specified when no staining is present. The maximum score was 15.
Change From Baseline in Eye Dryness Score as Measured by the VAS
时间窗: Baseline to Day 85
The Visual Analog Scale (VAS) where subjects were asked to rate their eye dryness (OU) by placing a vertical mark on the horizontal line to indicate their current level of discomfort. 0 mm corresponds to "No Discomfort," and 100 mm corresponds to "Maximal Discomfort." The length of the assessment line is 100 mm.
次要结局
未报告次要终点