A Study of AGN-195263 for the Treatment of Meibomian Gland Dysfunction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 232
- 试验地点
- 33
- 主要终点
- Percentage of Meibum Quality Responders in the Study Eye
研究概览
简要总结
This study will evaluate the safety and efficacy of AGN-195263 compared to vehicle in patients with meibomian gland dysfunction (MGD) in the eyelids.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meibomian gland dysfunction in both eyes
- •Best-corrected visual acuity of 20/40 or better in each eye
排除标准
- •Known or suspected prostate cancer
- •History of breast cancer
- •Using LATISSE® or any other eye lash growth-stimulating product at least 30 days prior to the screening visit, or anticipated use during the study
- •Contact lens wear in either eye during any portion of the study
- •Unable to instill eye drops correctly
- •History of corneal refractive surgery in either eye within 1 year
研究组 & 干预措施
AGN-195263 0.1%
1 drop of AGN-195263 0.1% instilled in each eye twice daily.
干预措施: AGN-195263 0.1% (Drug)
AGN-195263 0.03%
1 drop of AGN-195263 0.03% instilled in each eye twice daily.
干预措施: AGN-195263 0.03% (Drug)
AGN-195263 0.01%
1 drop of AGN-195263 0.01% instilled in each eye twice daily.
干预措施: AGN-195263 0.01% (Drug)
AGN-195263 Vehicle
1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
干预措施: AGN-195263 Vehicle (Drug)
结局指标
主要结局
Percentage of Meibum Quality Responders in the Study Eye
时间窗: Month 6
Meibum quality response is defined as a patient who experiences a reduction ≥ 50% in the number of meibomian glands with a Meibum Quality Score (MQS) of 2 or 3 in the study eye. The MQS is based on Mathers' meibum quality secretion grading 4-point scale where: 0 = Clear excreta or clear with small particles (normal viscosity), 1 = Opaque excreta with normal viscosity, 2 = Opaque excreta with increased viscosity (gel-like), and 3 = Secretions retain shape (or secretions do not express but a toothpaste-like substance can be seen at the opening of the orifice).
次要结局
- Percentage of Maximum Meibum Quality Score (MMQS) Responders in the Study Eye(Month 6)
- Percentage of Complete Overall Ocular Discomfort Responders(Month 6)