NCT07810972进行中（未招募）2 期
A Multi-center, Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Phase Ⅱ Clinical Trial to Evaluate the Safety and Efficacy of TJO-087
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change From Baseline in Corneal Staining Score at 12 weeks
研究概览
简要总结
This study aims to evaluate the therapeutic efficacy and safety of investigational product compared with placebo in adult patients with dry eye disease. Patients will receive investigational product or placebo for 3 months, and the therapeutic effect will be assessed based on the change in corneal staining score from baseline.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥20 years (male or female)
- •Patients with dry eye symptoms
- •Fluorescein corneal staining score(NEI scale) ≥4
- •Schirmer test result (without anesthesia) ≤10 mm/5 min in
- •Tear film break-up time (TBUT) <10 seconds
排除标准
- •Presence or history of systemic or ocular disorder or condition that could affect the interpretation of study results
- •Intraocular pressure (IOP) >21 mmHg
- •Planned use of contact lenses during the study period
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo BID
干预措施: Vehicle (Placebo solution) (Drug)
Experimental group A
Experimental
Investigational product QD
干预措施: TJO-087 (Drug)
Experimental group B
Experimental
Investigational product BID
干预措施: TJO-087 (Drug)
结局指标
主要结局
Change From Baseline in Corneal Staining Score at 12 weeks
时间窗: Week 12
Change from Baseline in corneal staining using blue fluorescein staining procedure at 12 weeks.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study Comparing Ivermectin Cream 1%, Soolantra™ Cream 1%, PrROSIVER® Cream1% to Placebo Control in the Treatment of Moderate to Severe Facial Rosacea.RosaceaNCT07795567Sun Pharmaceutical Industries, Inc.865
尚未招募
1 期
A Single- and Multiple- Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SYH2059 Powder for InhalationHealthy ParticipantsNCT07510958InnovStone Therapeutics Limited84
招募中
1 期
A Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SYH2085NCT07412353CSPC ZhongQi Pharmaceutical Technology Co., Ltd.74
已完成
2/3 期
Clinical Study on Diabetes supplement in participants with diabetes.CTRI/2024/04/065001Emil Pharmaceutical Industries Private Limited,120
已完成
Phase 3 4
Clinical trial on Dry eye symptomsCTRI/2025/02/080686Katra Phytochem (India) Private Limited100