NCT07185139尚未招募1 期
Exploratory Clinical Trial of MSCohi-O Lenses for Ocular Involvement in Sjögren's Syndrome
Guangdong ProCapZoom Biosciences Co., Ltd.0 个研究点目标入组 12 人开始时间: 2025年9月12日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 主要终点
- Adverse events
研究概览
简要总结
This study is aSingle-center, multiple-dosing, prospective, nonrandom, single-arm trial.
详细描述
This study is aSingle-center, multiple-dosing, prospective, nonrandom, single-arm trial. To evaluate the clinical safety and efficacy of MSCohi-O Lenses in patients with ocular involvement of Sjögren's syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-65 years old, including the boundary value, no gender restriction;
- •Subjects meeting the 2016 ACR/EULAR classification criteria for Sjögren's syndrome, and also meet the diagnostic criteria for ocular involvement.
- •Ocular signs and symptoms unresponsive to at least 3 months of conventional therapy, including artificial tears and topical or systemic corticosteroids.
- •Extra-ocular manifestations of Sjögren's syndrome clinically stable.
- •Subjects and their partners agree to use effective non-pharmacological contraception from screening through 6 months after the last dose and have no plans for conception during this period.
- •Willing to participate in the study, understand and sign the informed consent form (ICF).
排除标准
- •Known allergy to any component of the investigational drug.
- •Active ocular infection.
- •Presence of other significant ocular disease or trauma diagnosed prior to enrollment, including but not limited to glaucoma, uveitis, retinopathy, chemical injury, or thermal burns.
- •History of any ocular surgery within the preceding 6 months, including cataract surgery.
- •Participation in another interventional clinical study.
- •Use of any ophthalmic medication that may interfere with the study outcomes, such as other stem-cell-derived products.
- •Having serious underlying diseases of the heart, brain vessels, liver, kidneys, and hematopoietic system.
- •Pregnant or lactating women; women of childbearing potential must employ an effective contraceptive method (e.g., intrauterine device, oral contraceptive, or condom) during the study and for at least 3 months after the final dose of study drug.
- •Subjects deemed unsuitable for participation in this trial by the investigator.
研究组 & 干预措施
MSCohi-O Lenses Group
Experimental
Each subject will wear MSCohi-O Lenses for 12 hours a day, totally 14-day wearings.
干预措施: MSCohi-O Lenses (Drug)
结局指标
主要结局
Adverse events
时间窗: from subjects receiving administration to Day 29 post-administration
Incidence and severity of adverse events from subjects receiving administration to Day 29 post-administration.
次要结局
- corneal fluorescein staining(from baseline to Day 8, Day 15 and Day 29 post-administration)
- Tear film break-up time(from baseline on Day 8, Day 15 and Day 29 post-administration)
- ocular surface disease index scores(from baseline on Day 8, Day 15 and Day 29 post-administration)
- Schirmer's test(from baseline on Day 8, Day 15 and Day 29 post-administration)
研究者
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