Safety and Efficacy of AGN 210669 Ophthalmic Solution 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
- 172
- 主要终点
- Change From Baseline in Average Eye Intraocular Pressure (IOP)
研究概览
简要总结
The study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution in comparison with AGN-210669 vehicle and bimatoprost ophthalmic solution dosed once-daily each morning, in subjects with ocular hypertension or primary open-angle glaucoma. Subjects will be followed for 2 weeks.
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 75 Years（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
- •Females of non-childbearing potential
- •Subject requires IOP-lowering therapy in both eyes
- •IOP ≥ 22 mm Hg and ≤ 34 mm Hg
- •Has a visual acuity score of 20/100 or better in each eye
排除标准
- •Uncontrolled systemic disease
- •Active ocular disease
- •Alteration of existing chronic systemic medications
- •Known allergy or sensitivity to the study medications
- •Ophthalmic corticosteroids
- •Visual field loss which in the opinion of the investigator is functionally significant
- •History of ocular laser, intraocular surgery, or refractive surgery
研究组 & 干预措施
AGN-210669 ophthalmic solution, 0.075%
AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.
干预措施: AGN-210669 ophthalmic solution, 0.075% (Drug)
AGN-210669 ophthalmic solution, 0.05%
AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
干预措施: AGN-210669 ophthalmic solution, 0.05% (Drug)
AGN-210669 ophthalmic solution, 0.025%
AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
干预措施: AGN-210669 ophthalmic solution, 0.025% (Drug)
bimatoprost ophthalmic solution 0.03%
Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
干预措施: bimatoprost ophthalmic solution 0.03% (Drug)
AGN-210669 vehicle ophthalmic solution
AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
干预措施: AGN-210669 vehicle ophthalmic solution (Drug)
结局指标
主要结局
Change From Baseline in Average Eye Intraocular Pressure (IOP)
时间窗: Baseline, Day 14 Hour 0
IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes is 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).
次要结局
- Percentage of Patients With ≥ 20% Reduction From Baseline in Diurnal IOP(Baseline, Day 14)