NCT03762369Unknown3 期
Multi Center, Randomized, Double-blind, Active Controlled, Parallel Design, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-351 in Primary Open Angle Glaucoma or Ocular Hypertension Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 384
- 试验地点
- 1
- 主要终点
- Change in mean intraocular pressure at 12 weeks compared to baseline
研究概览
简要总结
The purpose of this study is to evaluate efficacy and safety of CKD-351.
详细描述
Multi center, Randomized, Double-blind, Active controlled, Parallel design, Phase 3 trial to evaluate the efficacy and safety of CKD-351 in primary open angle glaucoma or ocular hypertension patients.
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
- Triple (Participant, Care Provider, Investigator)
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
- •More than the age of 19 years old
- •Subjects who has primary Open-Angle Glaucoma or Ocular Hypertension
- •Subjects who sign on an informed consent form willingly
排除标准
- •Subjects with IOP(Intraocular Pressure) ≥35 mmHg at Visit 1 and Visit 2 (AM 09:00) at more than one eye
- •Subjects with a maximum corrected visual acuity ≤ 0.3 in the selected evaluation eye at Visit 2
- •Subjects who were diagnosed as below with monocular or both eye
- •Acute or Chronic Closed-Angle Glaucoma
- •Secondary Glaucoma
- •Pseudoexfoliation Glaucoma
- •Neovascular Glaucoma
- •Phacocyst capsular torn intraocular lens
- •Subjects with significant eye symptoms/signs(Abscesses, diplopia) or severe visual field impairment(Mean Deviation ≥ -25dB)
- •Subjects with severe dry eye syndrome or progressive retinal disease(Retinal degeneration, Diabetic retinopathy, Retinal detachment, Macular edema)
- •Subjects with inflammatory/infectious eye disease and active eye disease within the last 3 months
- •Subjects who have medical history following
- •Subjects with significant history of ocular trauma during the last 6 months, or who underwent surgical ophthalmic surgery
- •Subjects who received topical or systemic steroids within the last 1 months
- •Subjects who wore need to wear contact lenses during the study
- •Women who are nursing, pregnant or planning pregnancy during the study
- •Subjects with bronchial asthma or history
- •Subjects with severe renal impairment (creatinine clearance <30 ml / min at screening) or hyperchloremic acidosis
- •Subjects who have received any other investigational product within 1 month prior to randomization
- •Impossible subjects who participate in clinical trial by investigator's decision
研究组 & 干预措施
CKD-351
Experimental
Latanoprost+D930
干预措施: CKD-351 (Drug)
CKD-351
Experimental
Latanoprost+D930
干预措施: D930 (Drug)
Latanoprost
Active Comparator
干预措施: Latanoprost (Drug)
Latanoprost
Active Comparator
干预措施: Placebo of CKD-351 (Drug)
Latanoprost
Active Comparator
干预措施: Placebo of D930 (Drug)
D930
Active Comparator
干预措施: D930 (Drug)
D930
Active Comparator
干预措施: Placebo of CKD-351 (Drug)
结局指标
主要结局
Change in mean intraocular pressure at 12 weeks compared to baseline
时间窗: Baseline, 12 weeks
次要结局
- Change in mean intraocular pressure at 4 weeks, 8weeks compared to baseline(Baseline, 4 weeks, 8 weeks)
- Changes in intraocular pressure by measurement time(4 weeks, 8 weeks, 12 weeks)
研究者
研究点 (1)
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