Study Assessing Patient Satisfaction With LATISSE® for Increasing Eyelash Prominence
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 88
- 主要终点
- Percentage of Participants Who Are Satisfied or Very Satisfied With Their Eyelashes Overall
研究概览
简要总结
The purpose of this study is to determine patient satisfaction with LATISSE® treatment for increasing eyelash prominence.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Have inadequate eyelashes
- •Never used prescription eyelash growth products
排除标准
- •No visible eyelashes
- •Permanent eyeliner or eyelash implants
- •Semi-permanent eyelash tint, dye, or extensions within 3 months
- •Over-the-counter eyelash growth products within 6 months
- •Any disease, infection or abnormality of the eye or area around the eye
- •Eye surgery within 3 months, or the anticipated need for eye surgery during the study
- •Unable or unwilling to keep contact lenses out during drug application and for 30 minutes after application
研究组 & 干预措施
bimatoprost ophthalmic solution 0.03%
One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
干预措施: bimatoprost ophthalmic solution 0.03% (Drug)
bimatoprost vehicle solution
One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
干预措施: bimatoprost vehicle solution (Drug)
结局指标
主要结局
Percentage of Participants Who Are Satisfied or Very Satisfied With Their Eyelashes Overall
时间窗: Week 16
Participants rated their overall eyelash satisfaction by answering Eyelash Satisfaction Questionnaire (ESQ-9) question #3: "Overall, how satisfied are you with your eyelashes?" using a 5-point scale: -2=very unsatisfied (worst), -1=unsatisfied, 0=neutral, 1=satisfied or 2=very satisfied (best). The percentage of participants who rated their satisfaction as 1=satisfied or 2=very satisfied at Week 16 is reported.
次要结局
- Percentage of Participants With at Least a 1-Grade Increase in the Global Eyelash Assessment (GEA) Score(Baseline, Week 16)