NCT06337981已完成2 期
A Phase 2 Multicenter, Randomized, Double-blinded, Placebo-controlled Trial to Evaluate the Efficacy and Safety of AJU-S56 in Patients With Dry Eye Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Total corneal staining score (TCSS)
研究概览
简要总结
This study is planned to Evaluate the Efficacy and Safety of test drug (AJU-S56) compared to control drug(vehicle) in Patients with 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
- •Male and Female who over 19 years old
- •Moderate to Severe Dry Eye Disease Patients
- •Must meet all criteria listed below at least in one eye or both eyes. TCSS (National eye institute (NEI) scale)≥ 4 Schirmer test(without anesthesia) ≤ 10mm in 5 mins Tear break-up time ≤ 6 secs
- •Written informed consent to participate in the trial
排除标准
- •Those who have clinically significant eye disease not related to dry eye syndrome
- •Those who have medical history with intraocular surgery 12months before screening visit
- •Use of corticosteroid, beta blocker and anticholinergic agent within 4 weeks
- •Participation in other studies within 4weeks of screening visit
研究组 & 干预措施
Test group 1
Experimental
(AJU-S56 5%) and placebo(Vehicle), 1drop/1times, 3times in a day
干预措施: (AJU-S56 5% and placebo) (Drug)
Test group 2
Experimental
(AJU-S56 5%), 1drop/1times, 6times in a day
干预措施: AJU-S56 5% (Drug)
Comparator group
Placebo Comparator
Placebo(Vehicle), 1drop/1times, 6times in a day
干预措施: Placebo(Vehicle) (Drug)
结局指标
主要结局
Total corneal staining score (TCSS)
时间窗: WEEK 4(Visit 4) (*Baseline, Visit 2 is performed in Day 0, Week 0)
Total corneal staining score (TCSS) ≥4 at baseline (Total Max score : 15, bigger socre means worse outcome)
次要结局
- LGCSS(WEEK 2(Visit 3), 4(Visit 4), 8(Visit 5), 12(Visit 12) (*Baseline, Visit 2 is performed in Day 0, Week 0))
- TFBUT(WEEK 2(Visit 3), 4(Visit 4), 8(Visit 5), 12(Visit 12) (*Baseline, Visit 2 is performed in Day 0, Week 0))
研究者
研究点 (1)
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