A Phase IV, Prospective, Open-label, Multicentre, Single Arm, 3-month Proof of Concept Study to Assess the Effect of IKERVIS® Eye Drops Administered Once Daily on the Quality of Vision in Dry Eye Disease (DED) Patients With Severe Keratitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Santen SAS
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Correlation Between the Change From Baseline in VMR Measured With FVA System at Month 3 and the Change From Baseline in the CFS at Month 3.
研究概览
简要总结
The proposed 3-month study is a prospective, open-label, multicentre, phase IV, proof of concept study. The study is designed to assess the effect on the quality of vision of IKERVIS® (1mg/mL ciclosporin) eye drops administered once daily in dry eye disease (DED) patients with severe keratitis, as well as its safety and efficacy.
详细描述
In this phase IV clinical trial the Month 3 visit assessments will be used to assess the efficacy (quality of vision and other parameters) and safety of IKERVIS® in DED patients with severe keratitis.
To assess the effect on the quality of vision of IKERVIS® (1mg/ml ciclosporin) eye drops administered once daily in adult dry eye disease (DED) patients with severe keratitis over 3 months of treatment.
To assess the safety of DED patients with severe keratitis treated with IKERVIS® (1mg/mL ciclosporin) for 3 months.
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient eligibility is determined according to the following criteria:
- •In the opinion of the investigator, the patient is capable of understanding and complying with protocol requirements.
- •The patient signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures
- •Male or female patient is aged 18 years or above.
- •DED patients with persistent severe keratitis at the Screening and
- •Baseline Visits defined as the following:
- •CFS score of 3, 4 or 5 on the modified Oxford scale
- •Patient must be willing and able to undergo and return for scheduled study-related examinations.
- •The same eye (eligible eye) should fulfill all the above criteria.
排除标准
- •Patients with history of ocular trauma or ocular infection (viral, bacterial, fungal, protozoal) within 90 days before the Screening Visit and any ocular diseases other than dry eye disease requiring topical ocular treatment during the course of the study.
研究组 & 干预措施
IKERVIS® (1mg/mL ciclosporin) eye drops
one drop of study medication (IKERVIS®1mg/mL) once daily in each eye at bedtime during 3 months.
干预措施: 1mg/mL ciclosporin (Drug)
结局指标
主要结局
Correlation Between the Change From Baseline in VMR Measured With FVA System at Month 3 and the Change From Baseline in the CFS at Month 3.
时间窗: at month 3
Spearman's coefficient of correlation will be calculated at Month 3 between the change from baseline of Corneal Fluorescein Staining (CFS) and respectively the change from baseline of Visual Maintenance Ratio (VRM).
次要结局
未报告次要终点