A Phase 2b/3, Multicenter, Randomized, Double-masked, Vehicle-controlled Clinical Study to Assess the Efficacy and Safety of Topical CyclASol® for the Treatment of Signs and Symptoms of Dry Eye Disease (DED) (ESSENCE Trial)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novaliq GmbH
- 入组人数
- 328
- 试验地点
- 1
- 主要终点
- Change From Baseline in Ocular Surface Disease Index at Day 29
研究概览
简要总结
The objective of this study is to assess the efficacy, safety, and tolerability of CyclASol Ophthalmic Solution in comparison to vehicle for the treatment of the signs and symptoms of DED.
详细描述
This Phase 2b/3 study will assess the efficacy, safety and and tolerability of CyclASol Ophthalmic Solution as one drop twice daily versus vehicle.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed ICF (Informed Consent Form) and HIPAA (Health Insurance Portability and Accountability Act)
- •Patient-reported history of DED in both eyes
- •Current use of OTC (over-the-counter) and/or artificial tears for dry eye symptoms
- •Ability and willingness to follow instructions, including participation in all study assessments and visits
排除标准
- •Women who are pregnant, nursing or planning a pregnancy
- •Unwillingness to submit a urine pregnancy test at screening and the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control
- •Clinically significant slit-lamp findings or abnormal lid anatomy at screening
- •Ocular/periocular malignancy
- •History of herpetic keratitis
- •Active ocular allergies or ocular allergies that may become active during the study period
- •Ongoing ocular or systemic infection at screening or baseline
- •Wear of contact lenses within 3 months prior to screening or anticipated use of contact lenses during the study
- •History of no response to previous topical Cyclosporine A and/or use of topical Cyclosporine A or Liftigrast within 2 months prior to screening
- •Intraocular surgery or ocular laser surgery within the previous 6 months, or have any planned ocular and/or lid surgeries over the study period
- •Presence of uncontrolled systemic diseases
- •Presence of known allergy and/or sensitivity to the study drug or its components
研究组 & 干预措施
CyclASol Ophthalmic Solution
Cylclosporine A solution in vehicle
干预措施: CyclASol topical ocular, eye drops (Drug)
Vehicle Ophthalmic Solution
Vehicle only
干预措施: Vehicle topical ocular, eye drops (Drug)
结局指标
主要结局
Change From Baseline in Ocular Surface Disease Index at Day 29
时间窗: baseline and 1 month [day 29]
The OSDI score is a composite measure built on 12 questions,with totals ranging from 0 to 100, and higher scores representing a worse disease index.
Change From Baseline in Total Corneal Fluorescein Staining at Day 29
时间窗: baseline and 1 month [day 29]
CFS was assessed in each eye using the National Eye Institute (NEI) scale. A standardized grading system of 0-3 is used for each of the five areas on each cornea. Grade 0 will be specified when no staining is present. The maximum total score for each eye is 15. Higher values describe greater staining and corneal damage.
次要结局
未报告次要终点