Safety and Efficacy of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 125
- 主要终点
- Change From Baseline in Average Eye IOP
研究概览
简要总结
This study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution compared with bimatoprost ophthalmic solution (Lumigan®) as monotherapy and adjunctive therapy in patients with primary open-angle glaucoma or ocular hypertension.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Diagnosis of primary open-angle glaucoma or ocular hypertension in each eye
- •Requires bilateral treatment with an IOP-lowering medication
- •Best corrected visual acuity of 20/100 or better in each eye
排除标准
- •Use of oral, intramuscular, intravenous or topical ophthalmic corticosteroids within 2 months
- •Inability to fast for up to 10 hours
- •Prior refractive laser surgery (eg, LASIK, radial keratectomy, photorefractive keratectomy)
- •Intraocular surgery or IOP-lowering laser surgery (eg, laser trabeculoplasty) within 6 months
- •Current or anticipated use of artificial tears or any ocular medications aside from study medications during study
- •Anticipated wearing of contact lenses during study
研究组 & 干预措施
AGN-210669
AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1.
干预措施: AGN-210669 (Drug)
AGN-210669 + bimatoprost
AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% applied as 1 drop of each treatment in both eyes every evening during Month 2.
干预措施: AGN-210669 (Drug)
AGN-210669 + bimatoprost
AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% applied as 1 drop of each treatment in both eyes every evening during Month 2.
干预措施: bimatoprost (Drug)
AGN-210669 + bimatoprost vehicle
AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
干预措施: AGN-210669 (Drug)
AGN-210669 + bimatoprost vehicle
AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
干预措施: bimatoprost vehicle (Drug)
bimatoprost
bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1.
干预措施: bimatoprost (Drug)
bimatoprost + AGN-210669
bimatoprost ophthalmic solution 0.03% + AGN-210669 0.05% applied as 1 drop of each treatment in both eyes every evening during Month 2.
干预措施: AGN-210669 (Drug)
bimatoprost + AGN-210669
bimatoprost ophthalmic solution 0.03% + AGN-210669 0.05% applied as 1 drop of each treatment in both eyes every evening during Month 2.
干预措施: bimatoprost (Drug)
bimatoprost + bimatoprost vehicle
bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
干预措施: bimatoprost (Drug)
bimatoprost + bimatoprost vehicle
bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
干预措施: bimatoprost vehicle (Drug)
结局指标
主要结局
Change From Baseline in Average Eye IOP
时间窗: Baseline, Day 57
IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes are used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are recorded at Hours 0, 4, 8, and 12.
次要结局
- Change From Baseline in Worse Eye IOP(Baseline, Day 57)