A Phase 3, Multi-Center, Randomized, Double-Masked, Saline-Controlled Trial to Evaluate the Effect of SHR8058 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- Change from baseline in total Corneal Fluorescein Staining (NEI scale) at Day 57
研究概览
简要总结
The study is being conducted to evaluate the efficacy and safety of SHR8058 eye drops for patients with 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
- Triple (Participant, 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
- •Signed ICF (Informed Consent Form)
- •Subject-reported history of Drye Eye Disease (DED) in both eyes
- •Ability and willingness to follow instructions, including participation in all study assessments and visits
排除标准
- •clinically significant slit lamp findings or abnormal lid anatomy at screening, including eye trauma, pterygium, active blepharitis, and active lid margin inflammation;
- •Stevens-Johnson syndrome or other severe systemic autoimmune diseases;
- •underwent LipiFlow procedure or intention pulsed light therapy within 6 months before baseline, or received Meibomian gland massage treatment within 2 weeks before baseline;
- •received or removed permanent lacrimal plug within 3 months before baseline;
- •DED secondary to scarring, radiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells;
- •ocular or periocular malignancy;
- •active ocular allergies, or allergy to the study drug or its components;
- •ongoing ocular or systemic infection;
- •use of contact lenses within 1 month before screening;
- •intraocular surgery or ocular laser surgery within 6 months before enrollment;
- •uncontrolled systemic disease or history of herpetic keratitis;
- •use of topical steroids, topical cyclosporine, lifitegrast, serum tears, or topical anti-glaucoma medication within 60 days before screening;
- •used any known oral drugs that could have caused eye dryness within 1 month before screening;
- •participated in or were participating in other clinical trials drugs or device within 60 days before baseline;
- •inappropriate to participate for other reasons judged by the investigators.
研究组 & 干预措施
Treatment group A: SHR8058 eye drops
干预措施: SHR8058 eye drops (Drug)
Treatment group B: saline eye drops
干预措施: saline eye drops. (Drug)
结局指标
主要结局
Change from baseline in total Corneal Fluorescein Staining (NEI scale) at Day 57
时间窗: Baseline, Day 57
The National Eye Institute (NEI) scale relies on a chart that divides the cornea into five sections (central, superior, temporal, nasal, and inferior) and assigns a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the punctate keratitis, for a maximum total score of 15 points (sum of scores for each section).
Change from baseline in Dryness Score (visual analogue scale [VAS] Severity of Dryness) at Day 57
时间窗: Baseline, Day 57
Study staff will ask participants to rate their severity of ocular dryness (both eyes simultaneously) by placing a vertical mark on a horizontal line to indicate the level of discomfort (0 corresponds to "no dryness" and 100% corresponds to "maximal dryness").
次要结局
未报告次要终点