NCT06427031已完成3 期
A Multi-center, Randomized, Double-blinded, Active Control, Parallel, Phase 3 Trial to Evaluate the Efficacy and Safety of TJO-083 in Dry Eye Diseases Patients
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
- 271
- 试验地点
- 1
- 主要终点
- Change From Baseline in Corneal Staining at Week 4
研究概览
简要总结
In patients with dry eye syndrome, the test drug(TJO-083) or the control drug is administered for 12 weeks, and the corneal staining of each group would be evaluated. The purpose of this clinical Study is to demonstrate that the test drug is not clinically inferior to the control drug.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, age 20 or over
- •Has dry eye symptoms (minimum 3 months)
- •Screening both eyes, the corrected visual acuity is 0.2 or more
- •Written informed consent to participate in the trial
排除标准
- •The patients who treated with topical NSAIDs/hyaluronate sodium ophthalmic solutions within 2 weeks of randomized visits.
- •The patients with systemic or ocular disorders affecting the test results(ocular surgery, trauma, or disease) within 2 months of screening visits.
- •Intraocular pressure(IOP)> 21 mmHg
- •Patients with contact lens
研究组 & 干预措施
TJO-083
Experimental
TJO-083 : 1 drop 3 times a day
干预措施: TJO-083 (Drug)
Diquas-s Ophthalmic solution 3% 0.4mL
Active Comparator
1 drop 6 times a day
干预措施: Diquafosol ophthalmic sodium solution 3% (Drug)
结局指标
主要结局
Change From Baseline in Corneal Staining at Week 4
时间窗: Baseline and Week 4
Change from Baseline in corneal staining using blue fluorescein staining procedure at Week 4.
次要结局
- Change From Baseline in Corneal Staining at Week 8, 12(Baseline and Week 8 and 12)
- Change From Baseline in Conjunctival Staining at Week 4, 8 and 12(Baseline and Week 4, 8 and 12)
- Change From Baseline in Non-anesthetic Schirmer Test at Week 4, 8, 12(Baseline and Week 4, 8 and 12)
研究者
研究点 (1)
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