Safety and Efficacy of AGN-210961 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With 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
- 163
- 主要终点
- Part 1: Change From Baseline in Intraocular Pressure (IOP)
研究概览
简要总结
This study has 2 parts. Part 1 will evaluate the safety and IOP effects of 6 formulations of AGN-210961 ophthalmic solution in the study eye and bimatoprost ophthalmic solution 0.03% in the fellow eye for 7 consecutive days. Part 2 will evaluate the safety and IOP effects of a formulation (to be selected from part 1) of AGN-210961 in both eyes compared to bimatoprost ophthalmic solution 0.03% for 4 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
- Triple (Participant, Care Provider, 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
- •Ocular hypertension or primary open-angle glaucoma in each eye
排除标准
- •Any active ocular disease
- •Anticipated wearing of contact lenses during study
- •Anticipated use of artificial tears during study
- •Contraindication to pupil dilatation
研究组 & 干预措施
Part 1, AGN-210961 Formulation 1
AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
干预措施: AGN-210961 Formulation 1 (Drug)
Part 1, AGN-210961 Formulation 2
AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
干预措施: AGN-210961 Formulation 2 (Drug)
Part 1, AGN-210961 Formulation 3
AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
干预措施: AGN-210961 Formulation 3 (Drug)
Part 1, AGN-210961 Formulation 4
AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
干预措施: AGN-210961 Formulation 4 (Drug)
Part 1, AGN-210961 Formulation 5
AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
干预措施: AGN-210961 Formulation 5 (Drug)
Part 1, AGN-210961 Formulation 6
AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
干预措施: AGN-210961 Formulation 6 (Drug)
Part 2, AGN-210961 Formulation 7
AGN-210961 Formulation 7 in both eyes once daily for 4 weeks.
干预措施: AGN-210961 Formulation 7 (Drug)
Part 2, bimatoprost ophthalmic solution 0.03%
bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.
干预措施: bimatoprost ophthalmic solution 0.03% (Drug)
结局指标
主要结局
Part 1: Change From Baseline in Intraocular Pressure (IOP)
时间窗: Baseline, Day 7
IOP is a measurement of the fluid pressure inside the eye. Data are recorded at Hours 0, 2, 4, 6, 8, and 12. A negative number change from Baseline indicated a reduction in IOP (improvement). Data for bimatoprost-treated eyes are combined across groups.
Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP)
时间窗: Baseline, Day 29
IOP is a measurement of the fluid pressure inside the eye. Average IOP is the average of the 2 eyes for each patient at each time point. A negative number change from Baseline indicates a reduction in IOP (improvement). Data are recorded at Hours 0, 2, 4, 6, 8, and 12.
次要结局
未报告次要终点