Multi-Center, Randomized, Double-Masked, Placebo-Controlled, Phase 2b Study Evaluating the Safety and Efficacy of NCX 4251 Ophthalmic Suspension, 0.1% QD for the Treatment of Acute Exacerbations of Blepharitis (Mississippi)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Percentage of Study Eyes With Complete Cure (Score 0) of Blepharitis Signs and Symptoms at Day 15
研究概览
简要总结
This is a multi-center, randomized, double-masked, placebo-controlled, Phase 2b trial evaluating the safety and efficacy of NCX 4251 (fluticasone propionate nanocrystal) Ophthalmic Suspension 0.1% QD for the treatment of acute exacerbations of blepharitis.
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
- •documented history of blepharitis and meet qualifying criteria for an acute exacerbation of blepharitis in both eyes at Screening and Baseline/Day 1 Visits
- •have a qualifying best-corrected visual acuity
排除标准
- •abnormality of the eyelids or lashes (other than blepharitis), or previous eyelid surgery
- •IOP > 21 mmHg at Screening or Baseline/Day 1 Visits
- •use of steroids in the past 30 days or retinoids in the past 12 months
- •uncontrolled systemic disease
研究组 & 干预措施
NCX 4251
NCX 4251 Ophthalmic Suspension
干预措施: NCX 4251 (Drug)
Placebo
Vehicle of NCX 4251 Ophthalmic Suspension
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Study Eyes With Complete Cure (Score 0) of Blepharitis Signs and Symptoms at Day 15
时间窗: Day 15 Visit
Percentage of study eyes with Complete Cure (Score 0) in each of the following: Eyelid Margin Redness (0-none, 1-mild, 2-moderate, 3-severe), Eyelid Debris (0-none, 1-mild, 2-moderate, 3-severe), and Eyelid Discomfort (0-none, 1-mild, 2-moderate, 3-severe) at the Day 15 Visit
次要结局
- Treatment-emergent Adverse Events(29 days)
- Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Symptoms(Day 15 Visit)
- Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Sign (Fluorescein Staining of the Inferior Cornea)(Day 15 Visit)