NCT06291194招募中3 期
The Purpose of This Clinical Study is to Prove That the Test Drug (AJU-S56 5%) is Superior to the Control Drug After 24 Weeks of Administration to Patients Who Have Moderate or Severe Dry Eye Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 396
- 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 5%) 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
- •Ocular discomfort score (ODS) ≥ 3
- •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 worn contact lenses before 1week Screening visit or have to wear contact lenses or need to wear contact lenses during study period
- •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(AJU-S56 5%)
Experimental
QID(4 times in a day) for 24 Weeks after Randomization
干预措施: AJU-S56 5% (Drug)
Placebo group(Vehicle)
Placebo Comparator
QID(4 times in a day) for 24 Weeks after Randomization
干预措施: Placebo Group(Vehicle) (Drug)
结局指标
主要结局
Total corneal staining score (TCSS)
时间窗: WEEK 4, 8, 12
TCSS ≥4 at baseline (Total Max score : 15)
次要结局
- TFBUT(WEEK 4, 8, 12)
- LGCSS(WEEK 4, 8, 12)
研究者
研究点 (1)
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