A Phase 3, Multi-center, Open-label, Single-arm Clinical Trial to Assess the Long-term Safety and Tolerability of Topical CyclASol® for the Treatment of Dry Eye Disease in Subjects Who Completed the Clinical Trial CYS-004
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novaliq GmbH
- 入组人数
- 202
- 试验地点
- 2
- 主要终点
- Number of Subjects Reporting Any Adverse Events
研究概览
简要总结
The objective of this trial is to evaluate safety and tolerability of CyclASol during long-term use in subjects with Dry Eye Disease.
详细描述
Phase 3 multicenter, open-label, single-arm clinical trial to evaluate the safety, tolerability and efficacy of CyclASol in subjects with signs and symptoms of Dry Eye Disease. Subjects who completed the trial CYS-004, had a subject-reported history of dry eye in both eyes and met all other study eligibility criteria were dosed CyclASol bilaterally BID for 12 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have completed the clinical trial CYS-004 and habe been compliant with trial procedures
- •Signed ICF (Informed Consent Form)
- •Subject-reported history of DED in both eyes
- •Ability and willingness to follow instructions, including participation in all study assessments and visits
排除标准
- •Early termination of CYS-004
- •Clinically significant slit-lamp findings or ocular conditions that require prescriptive medical treatment and/or in the opinion of the investigator may interfere with trial parameters
- •Have a history of herpetic keratitis;
- •Have an ocular or periocular malignancy;
- •Be unwilling to avoid wearing contact lenses during the trial;
- •Have any planned ocular or eyelid surgeries during the trial period
- •Be a woman who is pregnant, nursing or planning a pregnancy
- •Unwillingness to submit a urine pregnancy test at all onsite visits if of childbearing potential
- •Women of childbearing potential not using an acceptable means of contraception
- •Presence of known allergy and/or sensitivity to the study drug or its components
- •Be currently using an investigational drug or device or have used an investigational drug or device within 60 days before Visit 1 other than for CYS-004
- •Have a condition or be in a situation (eg language barrier) which the investigator feels may put the subject at significant risk,may confound the trial results, or may interfere with the subject's participation in the trial significantly
研究组 & 干预措施
CyclASol Ophthalmic Solution
Cyclosporine A solution in vehicle
干预措施: CyclASol Ophthalmic Solution (Drug)
结局指标
主要结局
Number of Subjects Reporting Any Adverse Events
时间窗: 12 months
An adverse event was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not the event was considered drug related. 200 participants from the safety set were analyzed.
次要结局
未报告次要终点