Safety and Efficacy of Bimatoprost Solution in Increasing Overall Eyelash Prominence
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 278
- 主要终点
- Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 20 (Post-treatment)
研究概览
简要总结
This study evaluates the safety and effectiveness of topical bimatoprost solution for enhancing 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Dissatisfaction with eyelash prominence,
- •Eyelash prominence assessment of minimal or moderate,
- •Ability to provide written informed consent
排除标准
- •Subjects without visible lashes,
- •Asymmetrical (uneven lashes or longer on one side than the other) eyelashes,
- •Any eye disease or abnormality,
- •Eye surgery,
- •Permanent eyeliner,
- •Eyelash implants,
- •Eyelash extension application,
- •Any use of eyelash growth products within 6 months of study entry,
- •Treatments that may effect hair growth,
- •Subjects requiring eye drop medications for glaucoma,
- •Subjects having a situation or condition, which the study doctor feels might put you at risk, may make the study results confusing, or may interfere with the study.
研究组 & 干预措施
1
Bimatoprost 0.03% solution
干预措施: Bimatoprost 0.03% sterile solution (Drug)
2
Vehicle solution
干预措施: vehicle sterile solution (Drug)
结局指标
主要结局
Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 20 (Post-treatment)
时间窗: Baseline to Week 20
The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 \[minimal\], 2 \[moderate\], 3 \[marked\], 4 \[very marked\])
Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 16
时间窗: Baseline to Week 16
The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 \[minimal\], 2 \[moderate\], 3 \[marked\], 4 \[very marked\])
次要结局
- Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16(Baseline to Week 16)
- Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)(Baseline to Week 20)
- Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16(Baseline to Week 16)
- Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)(Baseline to Week 20)
- Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16(Baseline to Week 16)
- Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)(Baseline to Week 20)