Multi-Center, Randomized,Double-Masked, Vehicle-Controlled Study to Assess the Safety and Efficacy Study of Tavilermide Ophthalmic Solutions for the Treatment of Dry Eye
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 623
- 试验地点
- 1
- 主要终点
- Change From Baseline in Eye Dryness Score as Measured by the VAS
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of 5% tavilermide and 1% tavilermide ophthalmic solutions compared with placebo ophthalmic solution in treating the signs and symptoms 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 99 Years（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
1% Tavilermide ophthalmic solution
干预措施: Tavilermide ophthalmic solution (Drug)
5% Tavilermide ophthalmic solution
干预措施: Tavilermide ophthalmic solution (Drug)
Vehicle ophthalmic solution
干预措施: Placebo (Other)
结局指标
主要结局
Change From Baseline in Eye Dryness Score as Measured by the VAS
时间窗: Baseline to Day 85 in 5% Tavilermide versus Placebo
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.
Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale
时间窗: Baseline to Day 85 in 5% Tavilermide versus Placebo
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. Study eye is the 'worse eye', defined as the eye with worse (higher) score at baseline.
次要结局
未报告次要终点