An Investigator Initiated Multi-center Phase 4 Clinical Trial to Evaluate the Clinical Efficacy of Cyclosporine 0.1% (Ikervis®) for Moderate to Severe Dry Eye Patients With Inadequate Effects From Previous Treatment (IKE-03, Switching Study)
试验速览
- 阶段
- 4 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Cornea staining score (NEI scale)
研究概览
简要总结
A clinical trial to evaluate the efficacy and safety of Cyclosporine 0.1% (Ikervis®) for moderate to severe dry eye patients who changed to Cyclosporine 0.1% eye drop(Ikervis®) due to lack of treatment effects of the previous Cyclosporine 0.05% eye drop.
详细描述
Eligible patients who agree to participate in the clinical trial in writing will be administered Cyclosporine 0.1% eye drop(Ikervis®) one drop once daily for 12 weeks. Efficacy and safety will be evaluated at baseline, 4 weeks, 8 weeks, and 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 19 and less than 80 years old
- •A patient with moderate or severe dry eye who has used Cyclosporine 0.05% eye drop for more than 3 months and has no or insufficient treatment effect
- •No or insufficient treatment effect should meet the following criteria through tests used to diagnose dry eyes
- •A SANDE (Symptom Assessment in Dry Eye) score of 40 or more on the severity and frequency of dry eye symptoms.
- •Cornea staining score (NEI scale) 3 or more points
- •Tear Break Up Time(TBUT) 10 seconds or less
- •Tear volume tested by Tear Meniscometry less than 5mm
- •Has One or more of the dry eye symptoms; stinging, irritating, itching or blurred vision.
- •Use of diquafosol tetrasodium 3% eye drop and/or artificial tears are allowed with no change of products and dosage throughout the trial period
- •A person who voluntarily agrees in writing to participate in this clinical trial
排除标准
- •Use of eye drops within four weeks of the consent date such as steroids, glaucoma, allergies and anti-inflammatory drugs, etc.
- •Systematic steroid within four weeks of the consent date
- •Patients with pterygium
- •Start new immunosuppressive drugs or change in dosage that can affect immune function within four weeks of the consent date due to an unregulated systemic disease.
- •Severe MGD patient
- •Ophthalmic surgery (including Lasik/Lasek) and trauma in eyes within the last three months
- •Wearing contact lenses during a clinical trial period
- •Planning an eye surgery (including Lasik/Lasek) during the clinical trial period
- •Hypersensitivity to the clinical trial drug
- •Active or suspected eye infections
- •Pregnant or breastfeeding, or women planning to become pregnant
- •Participation in other clinical trials within three months
- •Any person who is deemed unfit for clinical trial by a investigator
研究组 & 干预措施
experimental group
Cyclosporine 0.1% (Ikervis®) eye drop - one drop once daily
干预措施: Cyclosporine 0.1% (Ikervis®) eye drop (Drug)
结局指标
主要结局
Cornea staining score (NEI scale)
时间窗: 12 weeks
The cornea staining score(NEI scale) is a grading scale for the corneal surface after fluorescein staining to help measure the efficacy of dry eye treatment. A standardized grading system of 0 to 3 is used for each of the five areas on each cornea. Grade 0 is specified when no staining is present, and the maximum score is 15.
次要结局
- SANDE(Symptom Assessment in Dry Eye) score(4 weeks, 8 weeks, 12 weeks)
- Conjunctival staining scores (NEI scale)(4 weeks, 8 weeks, 12 weeks)
- Ratio of patients who have improvement, deterioration, and no-change of cornea staining scores(NEI scale)(4 weeks, 8 weeks, 12 weeks)
- ODS (Ocular Discomfort Scale)(4 weeks, 8 weeks, 12 weeks)
- Patient Reported Outcome (PRO)(12 weeks)
- Tear Break-Up Time (TBUT)(4 weeks, 8 weeks, 12 weeks)
- Tear Meniscometry score(4 weeks, 8 weeks, 12 weeks)