NCT07656688招募中2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Phase 2 Clinical Study to Evaluate the Efficacy and Safety of HUC1-394 in Participant With Dry Eye Disease
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change from baseline in Total Corneal Staining Score (TCSS)
研究概览
简要总结
Clinical trial aims to determine the optimal dosing regimen by evaluating the efficacy and safety of HUC1-394 across different dosing frequencies in patients with moderate to severe 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥ 19 years at the time of screening
- •Trial participants who have experienced at least one of the following dry eye disease symptoms for at least 3 months prior to the time of screening
- •Trial participants who meet all of the following criteria in at least one eye (left or right) at the time of screening and randomization:
- •TCSS (NEI grading) ≥ 4 / Non-anesthetic Schirmer test result > 0 mm and ≤ 10 mm/5 min / TBUT < 7 seconds
- •OSDI score ≥ 23 at the time of screening
- •Trial participants who have provided voluntary written informed consent after receiving a full explanation and understanding of the clinical trial
排除标准
- •Trial participants with clinically significant ophthalmic diseases that may confound the interpretation of clinical trial results
- •Trial participants with blepharospasm, entropion, ectropion, or abnormalities of the eyelashes
- •Trial participants with any active ophthalmic disease that may affect the ocular surface, such as active allergy, anterior uveitis, and Stevens-Johnson syndrome
- •Trial participants with a history of corneal transplantation or neurotrophic keratitis
- •Trial participants with autoimmune diseases or immunodeficiency disorders
- •Pregnant or lactating women, or women of childbearing potential and men of reproductive potential who plan to conceive during the clinical trial or are unwilling to use an appropriate method of contraception
- •Trial participants who have participated in another clinical trial and received an investigational product or used an investigational medical device within 30 days prior to the time of screening
- •Trial participants who are deemed ineligible for participation by the investigator for any other reason in the clinical trial
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
HUC1-394 BID
Experimental
干预措施: HUC1-394 (Drug)
HUC1-394 TID
Experimental
干预措施: HUC1-394 (Drug)
结局指标
主要结局
Change from baseline in Total Corneal Staining Score (TCSS)
时间窗: Week 12
NEI scale (range 0-15; higher scores indicate a worse outcome)
Change from Baseline in Total Corneal Staining Score (TCSS) Using the National Eye Institute (NEI) Scale
时间窗: Week 12
NEI scale (range 0-15; higher scores indicate a worse outcome)
次要结局
未报告次要终点
研究者
研究点 (1)
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