A Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Safety of RVL-1201 in the Treatment of Acquired Blepharoptosis (Study RVL-1201-203)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 234
- 试验地点
- 34
- 主要终点
- Mean Change From Baseline in Intraocular Pressure (IOP) at Day 84
研究概览
简要总结
Phase 3 study to evaluate the extended safety of 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 (ICF). 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%
RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1%
干预措施: RVL-1201 (Drug)
Vehicle ophthalmic solution
Vehicle placebo ophthalmic solution
干预措施: Vehicle ophthalmic solution (Other)
结局指标
主要结局
Mean Change From Baseline in Intraocular Pressure (IOP) at Day 84
时间窗: Screening/Day 1 to Day 84
Intraocular pressure will be measured in mmHg utilizing a tonometer and using the standard of care. If possible, the same calibrated instrument should be used for a given subject throughout the study.
Mean Change From Baseline in Pupil Diameter (PD) at Day 84
时间窗: Screening/Day 1 to Day 84
Pupil diameter will be measured in millimeters (either horizontally or vertically if top of pupil is not visible in photograph) from the external photograph.
次要结局
未报告次要终点