A Double-Blinded, Parallel, Vehicle-Controlled Phase 2 Study of SHJ002 Sterile Ophthalmic Solution in Participants With Dry Eye Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 4
- 主要终点
- Change From Baseline in Total Corneal Fluorescein Staining (NEI Scale)
研究概览
简要总结
The purpose of this study is to measure efficacy and safety with SHJ002 sterile ophthalmic solution compared to vehicle in participants with Dry Eye Disease (DED). 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 BID for 84 days.
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
- Double (Participant, Investigator)
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.
- •Have DED in both eyes for ≥ 6 months
- •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 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 eye 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 BID for 84 days
干预措施: SHJ002/Vehicle (Drug)
Vehicle
Vehicle: topically administered to each eye BID for 84 days
干预措施: SHJ002/Vehicle (Drug)
结局指标
主要结局
Change From Baseline in Total Corneal Fluorescein Staining (NEI Scale)
时间窗: Baseline and Day 84
NEI Corneal Fluorescein Staining Score (range: 0 to 15, where higher scores indicate worse corneal staining). The score is the sum across five corneal regions (each 0-3).
次要结局
- Change From Baseline in SANDE Score(Baseline and Day 84)
- Change From Baseline in Eye Dryness Score (Visual Analogue Scale)(Baseline and Day 84)