NCT06717152已完成3 期
A Randomized, Double-masked, Parallel, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of SJP-0132 Eye Drops Compared With Placebo in Chinese Patients With Dry Eye Disease
Senju Pharmaceutical Science & Technology (Beijing) Co., Ltd.35 个研究点 分布在 1 个国家目标入组 427 人开始时间: 2024年12月30日最近更新:
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
- 427
- 试验地点
- 35
- 主要终点
- Change From Baseline in Corneal Fluorescein Staining (CFS) Score at Total Zone
研究概览
简要总结
This study will evaluate the safety and efficacy of SJP-0132 in Chinese Patients with Dry Eye.
Patients will be randomly assigned to receive either SJP-0132 or placebo.
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)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged between 18 and 70 at the time of the informed consent
- •Outpatient patients
- •The patient's self-described dry eye symptom is more than 6 months or has the clinical diagnosis certificate of dry eye in the past 6 months at the time of the informed consent
- •Tear film break-up time of <= 5 seconds at the beginning of screening and treatment period
排除标准
- •Patients who have previously used SJP-0132 eye drops
- •Patients who participated in or are currently participating in or planned to participate in other clinical studies within three months prior to the start of the screening period
- •Patients who plan to wear corneal contact lenses between the beginning of the screening period and the end of the treatment period
- •Patients who have undergone eye surgery (including laser surgery) or planned to undergo any eye surgery during the study period within one year prior to the beginning of the corneal transplantation surgery or screening period
- •Any ophthalmic disease except for the dry eye (including eyeball or periocular infection, allergic or proliferative eye disease) is present at the beginning of the screening period and at the beginning of the treatment period. However, it does not include chronic eye disease patients who do not need treatment and may not become worse before the end of the treatment period
- •Have known history of hypersensitivity or serious adverse reaction to any of the study drug ingredients
- •Patients suffering from serious cardiovascular, respiratory, endocrine, digestive, urinary, blood, neurological, mental, ocular or peripheral malignancies (cured in or at the beginning of the screening period but not exceeding five years), at the beginning of screening and treatment period
- •A patient at the beginning of screening and at treatment period who has a positive blood serum pregnancy test result or is in lactation, or a female patient who has planned pregnancy during the study period or has fertility but is unable to use effective contraception during the study period, or a female partner of a male patient who is unable to use effective contraception during the study
- •Patients identified at the beginning of screening and treatment period as researchers, research coordinators, researchers and immediate relatives of the persons referred to above
- •At the beginning of the screening and treatment period, investigators determine that patients who were unable to comply with the requirements of the program or were unable to come to hospital on schedule (e.g. patients who planned to travel or stay in the field during the period prior to the end of the treatment period)
- •At the beginning of the screening and treatment period, investigators decide that the patients who were not suitable for the trial were not suitable for the other reasons
- •Meet the other protocol-specified exclusion criteria
研究组 & 干预措施
SJP-0132
Experimental
The participants receive placebo for 2 weeks in run-in period, then SJP-0132 for 8 weeks in treatment period.
干预措施: SJP-0132 (Drug)
SJP-0132
Experimental
The participants receive placebo for 2 weeks in run-in period, then SJP-0132 for 8 weeks in treatment period.
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
The participants receive placebo for 2 weeks in run-in period, then placebo for 8 weeks in treatment period.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Corneal Fluorescein Staining (CFS) Score at Total Zone
时间窗: Day 29
CFS score ranged from 0 to 5, where '0' represents no fluorescein staining, and '5' represents severe staining on the cornea. The higher scores mean worse outcomes.
Change From Baseline in Eye Dryness Symptom (VAS)
时间窗: Day 8
Visual analog scale (VAS): "0" mean none, and "100" mean the worst imaginable for the symptom question.
次要结局
- Change From Baseline in Corneal Fluorescein Staining (CFS) Score at Total Zone(Day 8, 15, 57)
- Change From Baseline in Corneal Fluorescein Staining (CFS) Score in Each Zone (central, superior, temporal, nasal, and inferior)(Day 8, 15, 29, 57)
- Change From Baseline in Conjunctival Fluorescein Staining Score in Each Zone (temporal, temporal superior, temporal inferior, nasal superior, nasal inferior, and nasal)(Day 8, 15, 29, 57)
- Change From Baseline in Symptoms Score (VAS)(Day 8, 15, 29, 57)
- Change From Baseline in DEQ-5 Score(Day 29, 57)
- Change From Baseline in DEQS Score(Day 8, 15, 29, 57)
- Change From Baseline in Symptom Diary Score(Day 8, 15, 29, 57)
- Change From Baseline in Tear Film Break-up Time(Day 8, 15, 29, 57)
- Change From Baseline in Tear Secretion(Day 29, 57)
研究者
研究点 (35)
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