A Randomized, Double-Masked, Vehicle-Controlled, Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution (VOS) in Subjects With Dry Eye Syndrome (DES)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 508
- 试验地点
- 1
- 主要终点
- Number of Subjects With a ≥10 mm Increase From Baseline in Schirmer Tear Test (STT)
研究概览
简要总结
A Multi-Center, Phase 2/3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Voclosporin Ophthalmic Solution (0.05%, 0.10%, 0.20%) Compared to Vehicle in Subjects with Dry Eye Syndrome.
详细描述
This is a Phase 2/3, multi-center, randomized, double-masked, vehicle-controlled study to assess the efficacy and safety of three different concentrations of VOS when administered in both eyes (OU) twice a day (BID) over 12 weeks in subjects with mild to moderate DES. Subjects will undergo a 14- to 17-day run-in period in which VOS vehicle will be self-administered OU, BID. Subjects will be re-assessed to confirm they meet all of the inclusion criteria and none of the exclusion criteria. It is estimated that the study will enroll approximately 480 subjects across approximately 9 study centers. Eligible subjects will be randomized in a 1:1:1:1 ratio to one of the following study treatment groups after the 14- to 17-day run-in period.
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)
盲法说明
Double masked
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
- •Be at least 18 years of age.
- •Have a documented history of Dry Eye prior to Visit
- •Willing and able to follow protocol procedures and instructions.
- •Exclusion criteria:
- •Have undergone cataract or LASIK surgery within 1 year prior to Visit
- •Recent or current evidence of infection or inflammation in either eye.
- •Current evidence of blepharitis, other meibomian gland dysfunction, conjunctivitis or history of herpes simplex or zoster keratitis in either eye.
- •Have used any investigational drug or device within 30 days prior to Visit
- •Have used ophthalmic drugs (any topical eye medications) including prescription medication and over the counter (OTC) agents on the date of Visit
- •Have worn contact lenses 24 hours prior to Visit
- •Have used Xiidra® (lifitegrast) within 14 days prior to Visit
- •Have used Calcineurin Inhibitors (CNIs) such as Restasis® (cyclosporin ophthalmic emulsion) or CequaTM within 30 days prior to Visit 1.
排除标准
- 未提供
研究组 & 干预措施
0.05% Voclosporin Ophthalmic Solution (VOS)
0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
干预措施: 0.05% Voclosporin Ophthalmic Solution (VOS) (Drug)
0.10% VOS
0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
干预措施: 0.10% VOS (Drug)
0.20% VOS
0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
干预措施: 0.20% VOS (Drug)
Vehicle Ophthalmic Solution
Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks
干预措施: Vehicle Ophthalmic Solution (Drug)
结局指标
主要结局
Number of Subjects With a ≥10 mm Increase From Baseline in Schirmer Tear Test (STT)
时间窗: 4 Weeks
Number of subjects with a ≥10 mm increase from baseline in STT at Week 4 in the study eye. The STT scale is a measure of tear production with a minimum of 0 mm and no there is no specified maximum for this scale.
次要结局
- Change From Baseline in Eye Dryness(Value at 4 Weeks minus value at baseline)