An Investigator-Masked, Randomized, Parallel-Group Study of the Ocular Tolerability of Voclosporin Ophthalmic Solution Versus Restasis® in Subjects With Dry Eye Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change From Baseline in Drop Discomfort Post Dose Instillation on Day 1
研究概览
简要总结
Evaluate the tolerability, efficacy and safety of VOS versus Restasis® in subjects with mild to moderate Dry Eye Disease (DED).
详细描述
This is a Phase 2, multi-center, Investigator-masked, randomized, parallel-group study to evaluate the tolerability, efficacy and safety of VOS versus Restasis® over a 28-day treatment period in subjects with mild to moderate DED. Approximately 90 subjects will be randomized to either VOS or Restasis® at approximately 7 centers located in the US
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
- Single (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
- •Have a best corrected visual acuity (BCVA) in both eyes of +0.7 logarithm of the Minimum Angle of Resolution (logMAR) or better as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) chart.
- •Have a documented history of DED in both eyes supported by a previous clinical diagnosis.
- •Have ongoing DED, as defined by at least one eye (if one eye, the same eye) meeting all the following criteria:
- •A symptom severity score of ≥30 for Eye Dryness on a Visual Analog Scale (VAS) (0-100)
- •An unanesthetized Schirmer Tear Test (STT) score of ≥1 mm and ≤10 mm per 5 minutes (Note: STT Score obtained at Visit 1)
- •Evidence of ocular surface staining (total fluorescein staining score of at least 3 [0-15 scale]).
- •Have normal lid anatomy.
排除标准
- •Have any known hypersensitivity or contraindication to study treatments (including excipients), topical anesthetics or vital dyes.
- •Be unable to demonstrate correct instillation of over-the-counter (OTC) ocular lubricant.
- •Report discomfort in both eyes from instillation of OTC ocular lubricant during Visit 2 (based on score of ≥30 on the Drop Discomfort VAS).
- •Have used Restasis® (cyclosporine ophthalmic emulsion) within 30 days prior to Visit
- •Have used Restasis® for more than 1 month (if prior use is reported).
- •Have used Xiidra® (lifitegrast ophthalmic solution) within 14 days prior to Visit
- •Have had corneal graft surgery in either eye within 1 year.
- •Have recent or current evidence of ocular infection or inflammation in either eye.
- •Have current evidence of clinically significant blepharitis (defined as requiring lid hygiene therapy), conjunctivitis, or a history of herpes simplex or zoster keratitis in either eye.
研究组 & 干预措施
Voclosporin ophthalmic solution (VOS)
0.2% VOS, Twice Daily (BID), both eyes for 28 days
干预措施: Voclosporin Ophthalmic Solution (Drug)
Comparator
0.05% cyclosporine ophthalmic emulsion (Restasis®) BID, both eyes for 28 days
干预措施: Restasis® (Drug)
结局指标
主要结局
Change From Baseline in Drop Discomfort Post Dose Instillation on Day 1
时间窗: 1-minute Post Dose 1 installation (Day 1)
Drop Discomfort was assessed using the Individual Symptom Severity Assessment Visual Analog Scale (VAS) where the subject will complete the assessment 1 minute post-instillation on Day 1. The VAS scale is 0 - 100, where 0 corresponds to "no discomfort" and 100 corresponds to "maximal discomfort".
次要结局
- Change From Baseline in Foreign Body Sensation Post Dose Instillation on Day 28(28 days)
- Change From Baseline in Itching Post Dose Instillation on Day 28(28 days)
- Change From Baseline in Drop Discomfort Post Dose Instillation on Day 28(Day 28)
- Change From Baseline in Eye Dryness Post Dose Instillation on Day 28(28 days)
- Change From Baseline in Fluorescein Corneal Staining (FCS) Score(28 days)
- Change From Baseline in Burning/Stinging Post Dose Instillation on Day 28(Day 28)
- Change From Baseline in Photophobia Post Dose Instillation on Day 28(28 days)
- Change From Baseline in Eye Pain Post Dose Instillation on Day 28(28 days)
- Change From Baseline in Symptom Assessment in Dry Eye Score (SANDE)(Day 28)
- Change From Baseline in Unanesthetized Schirmer Test Score(28 days)
- Change From Baseline in the Total of All Individual Symptom Severity Assessment Scores(Day 28)