NCT05841043已完成3 期
A Multi-Center, Randomized, Double-masked, Vehicle-Controlled Phase III Clinical Study to Assess the Efficacy and Safety of SHR8028 Eye Drops for the Treatment of Dry Eye Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 1
- 主要终点
- Change in total corneal fluorescein staining (tCFS) score (National Eye Institute [NEI] scale) from baseline on Day 29
研究概览
简要总结
The study is being conducted to assess the efficacy, safety and tolerability of SHR8028 eye drops in comparison to the vehicle for the treatment 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
- 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
- •Age ≥ 18 years old;
- •Provide written informed consent form;
- •Have a subject reported history of dry eye disease in both eyes for at least 180 days before the screening visit (visit 0);
- •Be currently (within 30 days before visit 0) using over-the-counter (OTC) eye drops, lubricating gels or tear neurostimulator device (such as True TearTM), and/or artificial tears for dry eye symptoms;
- •Have at least one eye meets criteria of moderate to severe dry eye both at visit 0&1
- •Be able and willing to follow instructions and participate in all study assessments and visits.
排除标准
- •Have any clinically significant slit-lamp findings at visit 0 that require treatment with prescription drugs and/or in the opinion of the investigator may interfere with study parameters, such as trauma, Stevens-Johnson syndrome, or advanced epithelial basement membrane disease;
- •Have dry eye disease secondary to scar formation, such as radiation, alkali burn, cicatricial pemphigus, and destruction of conjunctival goblet cells (i.e., destruction of conjunctival goblet cells caused by vitamin A deficiency);
- •Have active ocular allergy or ocular allergy that may occur during the study;
- •Be diagnosed with an ongoing ocular or systemic infection (bacterial, viral, or fungal), including fever, or be undergoing treatment with antibiotics at visit 0 and visit 1;
- •Be a woman who is pregnant, breastfeeding, or planning pregnancy;
- •Have an uncontrolled systemic disease;
- •Have allergies to investigational medicinal product (IMP) or its components: cyclosporin A or semi-fluorinated alkanes (SFA);
- •Be currently participating in other drug or device trials, or have used other investigational drugs or devices within 60 days before visit 0;
- •Have a condition which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere with the subject's participation in the study significantly;
- •Have received or removed lacrimal duct embolism within 90 days before visit 0, or plan to receive or remove lacrimal duct embolism during the study.
研究组 & 干预措施
SHR8028 eye drops
Experimental
干预措施: SHR8028 eye drops (Drug)
Vehicle
Placebo Comparator
干预措施: Vehicle eye drops. (Drug)
结局指标
主要结局
Change in total corneal fluorescein staining (tCFS) score (National Eye Institute [NEI] scale) from baseline on Day 29
时间窗: Baseline, Day 29
Change in eye dryness score (visual analogue scale [VAS] Severity of Dryness) from baseline on Day 29
时间窗: Baseline, Day 29
次要结局
未报告次要终点
研究者
研究点 (1)
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