NCT03565887已完成3 期
A Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Safety and Efficacy of RVL-1201 in the Treatment of Acquired Blepharoptosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 35
- 主要终点
- Mean Change in Number of Points Seen on the Leicester Peripheral Field Test (LPFT) in RVL-1201 Group vs. Vehicle Group
研究概览
简要总结
Phase 3 study to evaluate the safety and efficacy of treatment with RVL-1201 compared to placebo for treatment of blepharoptosis. Eligible subjects will be randomized to one of 2 treatment arms.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 9 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female 9 years of age or older
- •Females must not be pregnant or planning to get pregnant and must use acceptable form of contraception
- •Must be able to self-administer study medication
- •Must be able to understand and sign an informed consent form. For minor subjects, the subject's parent or legal guardian must provide permission by signing an ICF on behalf of the subject and the subject should provide assent.
排除标准
- •Congenital ptosis
- •Horner syndrome
- •Myasthenia gravis
- •Mechanical ptosis
- •Previous ptosis surgery
- •Resting heart rate outside the normal range
- •Hypertension with resting diastolic blood pressure
- •Pregnancy or lactation
研究组 & 干预措施
RVL-1201 ophthalmic solution 0.1%
Experimental
RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1%
干预措施: RVL-1201 (Drug)
Vehicle ophthalmic solution
Placebo Comparator
Vehicle placebo ophthalmic solution
干预措施: Vehicle ophthalmic solution (Other)
结局指标
主要结局
Mean Change in Number of Points Seen on the Leicester Peripheral Field Test (LPFT) in RVL-1201 Group vs. Vehicle Group
时间窗: Mean change from Baseline (Day 1, Hour 0) compared with Day 1, (Hour 6), and Day 14 (Hour 2)
LPFT Total Score is the number of points seen in the top 4 rows on the LPFT. Possible scores range from 0 (no points seen) to 35 (all points seen).
次要结局
- Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye(Baseline Day 1 (Hour 0) and Day 1, Day 14, and Day 42)
研究者
研究点 (35)
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