A Phase 3, Multi-center, Randomized, Double-masked, Vehicle-controlled Clinical Trial to Assess the Efficacy and Safety of Topical CyclASol® for the Treatment of Dry Eye Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novaliq GmbH
- 入组人数
- 834
- 试验地点
- 3
- 主要终点
- Change From Baseline in Eye Dryness Score
研究概览
简要总结
The objective of this pivotal trial is to assess the efficacy, safety and tolerability of CyclASol in comparison to the vehicle for the treatment of signs and symptoms of Dry Eye Disease (DED).
详细描述
This Phase 3 study will assess the efficacy, safety and tolerability of CyclASol 0.1% Ophthalmic Solution administered bilaterally 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)
- •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
- •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
- •Randomized in a previous CyclASol trial
研究组 & 干预措施
CyclASol Ophthalmic Solution
Cyclosporine 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 Eye Dryness Score
时间窗: baseline and 1 month [day 29]
Eye dryness score is rated on a visual analogue scale (VAS) ranging from 0-100; 0 corresponds to no discomfort and 100 to maximum discomfort.
Change From Baseline in Total Corneal Fluorescein Staining
时间窗: baseline and 1 month [day 29]
Total Corneal Fluorescein Staining (tCFS) is graded based on the National Eye Institute (NEI) scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst). The total score is the sum of the 5 subregions ranging from 0 (best) - 15 (worst).
次要结局
- Change From Baseline in Total Conjunctival Lissamine Green Staining(baseline and 1 month [day 29])
- Change From Baseline in Central Corneal Fluorescein Staining(baseline and 1 month [day 29])
- Proportion of Responders in Central Corneal Fluorescein Staining Score(baseline and 1 month [day 29])
- Proportion of Responders in Total Corneal Fluorescein Staining Score(baseline and 1 month [day 29])
- Change From Baseline in Total Corneal Fluorescein Staining(baseline and 2 weeks [day 15])
- Change From Baseline in Visual Analogue Scale (VAS) for Blurred Vision(baseline and 1 month [day 29])