Bimatoprost in the Treatment of Eyelash Hypotrichosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 464
- 主要终点
- Percentage of Participants With at Least a 1-Grade Increase (Improvement) From Baseline in the Investigator's Assessment of Overall Eyelash Prominence (GEA)
研究概览
简要总结
This study will evaluate the safety and efficacy of bimatoprost solution formulation A compared with bimatoprost solution 0.03% (LATISSE®) and vehicle in the treatment of eyelash hypotrichosis (inadequate eyelashes).
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
- 否
入选标准
- •Male and female adult patients with eyelash hypotrichosis (inadequate eyelash growth).
排除标准
- •Damage to eyelid area (scarring) that may prevent growth of eyelashes
- •Active eye diseases (glaucoma, uveitis, eye infections, chronic blepharitis or severe dry eye)
- •Eye or eyelid surgery (including laser, refractive, intraocular filtering surgery, blepharoplasty) during the 3 months prior to screening
- •Current eyelash implants of any kind
- •Eyelash tint or dye application within 2 months of baseline
- •Eyelash extensions application within 3 months of baseline
- •Use of eyelash growth products within 6 months of baseline
- •Treatments that may affect hair growth (minoxidil, cancer chemotherapeutic agents, etc) within 6 months prior to baseline.
研究组 & 干预措施
bimatoprost formulation A solution
Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
干预措施: bimatoprost formulation A solution (Drug)
bimatoprost solution 0.03 %
Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
干预措施: bimatoprost solution 0.03 % (Drug)
vehicle of bimatoprost formulation A solution
Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
干预措施: vehicle of bimatoprost formulation A solution (Drug)
vehicle of bimatoprost solution 0.03 %
Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
干预措施: vehicle of bimatoprost solution 0.03 % (Drug)
结局指标
主要结局
Percentage of Participants With at Least a 1-Grade Increase (Improvement) From Baseline in the Investigator's Assessment of Overall Eyelash Prominence (GEA)
时间窗: Baseline, Month 4
The investigator evaluated the overall eyelash prominence in both eyes using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked. A 1-grade improvement in the GEA score from Baseline indicated improvement.
次要结局
- Change From Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA(Baseline Month 4)
- Percentage of Participants Satisfied or Very Satisfied in the Patient's Assessment of Overall Eyelash Satisfaction as Measured by the Eyelash Satisfaction Questionnaire (ESQ-9)(Month 4)
- Change From Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA(Baseline, Month 4)
- Change From Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA)(Baseline, Month 4)