NCT05017844已完成2 期
A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel Phase 2b/3 Study to Evaluate the Efficacy and Safety of KSR-001 in Patients With Dry Eye Syndrome
Kukje Pharma1 个研究点 分布在 1 个国家目标入组 222 人开始时间: 2020年2月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of KSR-001 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
- Double (Participant, 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
- •Male and Female who over 19 years old
- •Those who have had symptoms of dry eye for at least 6 months (foreign body sensation, dryness, glare, pain pain, blurred vision, etc.) and Those whose symptoms do not improve with conservative treatment such as artificial tears
- •Those who meet below criteria at least one of two eyes
- •Those who have over than score 4 in corneal staining test
- •Tear secretion test without anesthesia(Schirmer test) result would be under 10mm/5min (If the test result is 0mm/5min, it should be over than 3mm/5min on the nasal stimulation schirmer test in the same eye)
- •both eyes, the corrected visual acuity is 0.2 or more
- •Written consent voluntarily to participate in this clinical trial
排除标准
- •During this clinical trial period, When Rebamipide treatment is expected due to gastrointestinal disorder or gastritis
- •Within 90 days of the screening visit, if systemic steroid steroids or systemic immunosuppressants were used
- •Within 90 days of the screening visit, If there is a history of other ophthalmic surgeries including the use of punctum plugs or puncture closure surgery
- •If it is a clinically significant ophthalmic disease that is not caused by dry eye syndrome and may affect the interpretation of the results of this clinical trial
- •Within 90 days of the screening visit, Those who have undergone vision correction surgery such as LASIK or LASIK
- •Those with intraocular pressure (IOP) exceeding 21 mmHg or with glaucoma undergoing drug treatment
- •Those with hypersensitivity to the ingredient of this clinical trial drug
- •Patients planning to wear contact lenses during the clinical trial period
- •In the case of one of the following
- •Creatinine level more than twice the upper limit of normal range
- •AST or ALT levels greater than twice the upper limit of normal range
- •History of malignancy (except for cases where there has been no recurrence for more than 5 years after surgery)
- •Within 1 year before screening, Those who have been diagnosed with alcohol or drug abuse and are receiving treatment
- •In the case of women of childbearing potential, those who do not consent to contraception by a medically accepted method of contraception during the clinical trial period (IUD, Intrauterine device or IUS, Intrauterine system), tubal ligation, double blocking method (male condom, female condoms, cervical caps, contraceptive diaphragms, and Combination of blocking methods such as contraceptive sponges)
- •Pregnant or lactating women
- •within 30 days before participating in the clinical trial, Those who have applied other clinical trial drugs or medical devices
- •Patients judged by other investigators as unsuitable to participate in this clinical trial
研究组 & 干预措施
KSR-001-04
Placebo Comparator
KSR-001-04 eyedrops recieved one drop to both eyes four times a day for 12 weeks.
干预措施: KSR-001-04 (Drug)
KSR-001-02
Experimental
KSR-001-02 eyedrops recieved one drop to both eyes four times a day for 12 weeks.
干预措施: KSR-001-02 (Drug)
KSR-001-03
Experimental
KSR-001-03 eyedrops recieved one drop to both eyes four times a day for 12 weeks.
干预措施: KSR-001-03 (Drug)
结局指标
主要结局
Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF)
时间窗: Baseline, 12 weeks
FCS indicates the damage to the corneal epithelium. The degree of staining of the cornea after blue fluorescein staining under the slit lamp illumination of a cobalt blue light source was evaluated according to the National Eye Institute/Industry grading system. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated(0-15)(0 is better).
次要结局
- Fluorescein Corneal Staining (FCS)(Baseline, 4 weeks, 8 weeks)
- Lissamine Green Conjunctival Staining (LGCS)(Baseline, 4 weeks, 8 weeks, 12 weeks)
- Ocular Surface Disease Index (OSDI)(Baseline, 4 weeks, 8 weeks, 12 weeks)
- Unanesthetized Schirmer's test(Baseline, 4 weeks, 8 weeks, 12 weeks)
- Tear Film Break-up Time (TBUT)(Baseline, 4 weeks, 8 weeks, 12 weeks)
研究者
研究点 (1)
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