Safety and Pharmacodynamics Study of AGN-207281 Ophthalmic Solutions Compared With Timolol Ophthalmic Solution or Placebo in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 50
- 主要终点
- Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14
研究概览
简要总结
This is an exploratory study that will evaluate the safety and pharmacodynamics of up to 3 doses of AGN-207281 based on an ongoing review of data during the study period compared with timolol ophthalmic solution or placebo in patients with ocular hypertension or primary open-angle glaucoma.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ocular hypertension or primary open-angle glaucoma in each eye
- •Requires IOP-lowering therapy in both eyes
- •Visual acuity score of 20/100 or better in each eye
排除标准
- •Experienced significant weight change (over 10 pounds) within 60 days
- •History of alcohol or drug addiction
- •History of migraines or frequent headaches
- •Anticipated wearing of contact lenses during the study
- •Required chronic use of ocular medications during study
- •Eye surgery within 6 months
- •Use of systemic beta blockers (eg, atenolol, propranolol) within 2 months
- •Use of oral, intramuscular, intravenous corticosteroids within 21 days
- •Use of ophthalmic corticosteroids within 2 months
研究组 & 干预措施
AGN-207281 ophthalmic solution
AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14
干预措施: AGN-207281 ophthalmic solutions (0.1% and 0.3%); AGN-207281 vehicle ophthalmic solution (placebo) (Drug)
Timolol ophthalmic solution 0.5%
timolol ophthalmic solution 0.5%
干预措施: timolol ophthalmic solution 0.5% (Drug)
Placebo
AGN-207281 vehicle ophthalmic solution (Placebo)
干预措施: AGN-207281 vehicle ophthalmic solution (Placebo) (Drug)
结局指标
主要结局
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14
时间窗: Baseline, Day 14
Change from baseline in worse eye IOP at day 14. Worse eye IOP refers to the eye with the worse (highest) baseline IOP (a measurement of the fluid pressure inside the eye). A negative number change from baseline indicates a reduction in IOP (improvement).
次要结局
- Mean Concentration of AGN-207281 in Plasma at Day 7(Day 7)
- Mean Concentration of AGN-207281 in Plasma at Day 14(Day 14)