NCT02777723Unknown3 期
Active Controlled, Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-350 Eye Drops in Patients With Dry Eye Syndrome
适应症
干预措施
试验速览
- 阶段
- 3 期
- 入组人数
- 138
- 试验地点
- 14
- 主要终点
- Changes in Corneal Staining by Oxford scale from Baseline and at Week 4
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of CKD-350 in patients with dry eye syndrome
详细描述
Active controlled, randomized, double-blind, multi-center, phase 3 trial to evaluate the efficacy and safety of CKD-350 eye drops in patients with dry eye syndrome
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
- •More than the age of 19 years old
- •Subjects with dry eye symptoms for at least 3 month prior to screening
- •Subjects who have following values 1) ≥ 2 point of corneal staining score 2) ≤ 10 seconds of Tear Break-up Time 3) ≤10mm/5min of Schirmer I Test
- •Subjects who have a visual acuity equal to or better than 0.2 in both eyes
- •Subjects who sign on an informed consent form willingly
排除标准
- •Subjects who have clinically significant ocular surface diseases, abnormal corneal susceptibility and abnormal epiphora
- •Subjects who have medical history following 1) Abnormal eyelids function including abnormality of eyelid or eyelash 2) Ophthalmology operation within 1 year 3) Active ocular infection at present or treatment of allergic eye diseases 4) Herpetic keratopathy, conjunctiva scar from cicatricial keratoconjunctivitis(alkali injuries, stevens-johnson syndrome, ocular cicatricial pemphigoid), pterygium, congenital lacrimal gland absence, neural keratitis, keratoconus
- •Subjects who have received occlusion therapy with lacrimal or punctal plugs within 3 months or have a surgery plan in clinical trial
- •Subjects who wore contact lenses within 3 months or need to wear contact lenses during the study
- •Subjects who take steroidal or immunosuppressive drug within 1 month
- •Over 22mmHg IOP(Intraocular Pressure)
- •Subjects who have malignant tumor within 5 years
- •Subjects with known hypersensitivity to investigational product
- •Women who are nursing, pregnant or planning pregnancy during the study
- •Subjects who have received any other investigational product within 1 month prior to the first dosing
- •Impossible subjects who participate in clinical trial by investigator's decision
研究组 & 干预措施
Sodium Hyaluronate
Active Comparator
Isotonic 0.3% Sodium Hyaluronate
干预措施: Isotonic 0.3% Sodium Hyaluronate (Drug)
CKD-350
Experimental
Xenobella
干预措施: Xenobella (Drug)
结局指标
主要结局
Changes in Corneal Staining by Oxford scale from Baseline and at Week 4
时间窗: Baseline, week 4
次要结局
- Changes in Ocular Surface Disease Index from Baseline and at week 2, 4(Baseline, week 2, 4)
- Changes in Tear Break-up Time from Baseline and at Week 2, 4(Baseline, Week 2, 4)
- Changes in Schirmer I Test from Baseline and at Week 2, 4(Baseline, Week 2, 4)
- Changes in Corneal Staining by Oxford scale from Baseline and at Week 2(Baseline, week 2)
研究者
研究点 (14)
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