A Clinical Study on the Safety and Efficacy of SHJ002 Sterile Ophthalmic Solution in the Treatment of Corneal Erosion in Patients With Sjogren's Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 6
- 主要终点
- Change From Baseline to Week 12 in Total Corneal Fluorescein Staining
研究概览
简要总结
The purpose of this study is to measure efficacy and safety with 0.25% SHJ002 sterile ophthalmic solution compared to vehicle in treating corneal erosion in Sjogren's patients.
SHJ002 is an antisense oligonucleotide to neutralize a specific microRNA.
详细描述
Participants will be randomized to treatment with SHJ002 Ophthalmic Solution or vehicle which will be administered to each eye twice daily for 12 weeks.
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)
盲法说明
Double-Blinded, Parallel, Vehicle-Controlled
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
- •Male or female participants 18 years of age or older inclusive, at the time of signing the informed consent.
- •Diagnosis with Sjogren's syndrome and have corneal erosion
- •Female participants must be 1 year postmenopausal, surgically sterilized, or females of childbearing potential with a negative urine pregnancy test
排除标准
- •Ocular surface corneal disease, other than corneal erosion and dry eye disease (DED).
- •Lid margin disorder other than meibomian gland dysfunction (MGD)
- •Presence of any ocular condition
- •Any history of eyelid surgery or intraocular/ocular surgery
- •Cauterization of the punctum or punctal plug
- •Use of lid scrubs containing chemicals or baby shampoo, or eyelid makeup
- •Use of any of the contraindicated drugs medications
- •Any changes in the dosing of any chronically used systemic drug
- •Disease, condition, or disorder that in the judgement of Investigator could confound study assessments or limit compliance to study protocol
- •Known history of alcohol and/or drug abuse within 12 months
- •Known allergy or contraindication to any component of investigational product (IP) formulation or diagnostic agents.
- •Participation in any drug or device clinical investigation within 30 days
研究组 & 干预措施
SHJ002
SHJ002 Ophthalmic Solution: topically administered to each eye twice daily for 12 weeks
干预措施: SHJ002 (Drug)
Vehicle
Vehicle: topically administered to each eye twice daily for 12 weeks
干预措施: Vehicle (Other)
结局指标
主要结局
Change From Baseline to Week 12 in Total Corneal Fluorescein Staining
时间窗: Baseline to Week 12
The total corneal fluorescein staining score will be assessed using the NEI grading scale (0-15 points; higher scores indicate more severe staining).
次要结局
- Change From Baseline to Week 12 in Inferior Corneal Fluorescein Staining (iCFS)(Baseline to Week 12)
- Change From Baseline to Week 12 in SANDE Score(Baseline to Week 12)