A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety, Efficacy, and Pharmacokinetics of the Fixed Combination of AGN-199201 and AGN-190584 in Patients With Presbyopia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 151
- 试验地点
- 25
- 主要终点
- Weighted Average Change From Baseline in Uncorrected Near Visual Acuity (UNVA) Letters in the Nondominant Eye
研究概览
简要总结
This is a safety, efficacy and pharmacokinetics study of the fixed combination of AGN-199201 and AGN-190584 in participants with presbyopia (inability to focus on items close-up).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Normal vision at distance, either natural or post corneal laser refractive surgery, with presbyopia in each eye and complaints of poor near vision that impacts activities of daily living
排除标准
- •Use of any topical ophthalmic medications, including artificial tears other than the study medications during the study
- •Corneal abnormalities in either eye that interfere with visual acuity
- •History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery or any intraocular surgery
- •Diagnosis of glaucoma or ocular hypertension.
研究组 & 干预措施
Cohort 1: Vehicle Control
Vehicle dosed in both eyes administered once daily during office visits 1 through 5.
干预措施: AGN-199201 Vehicle (Drug)
Cohort 1: Vehicle Control
Vehicle dosed in both eyes administered once daily during office visits 1 through 5.
干预措施: AGN-190584 Vehicle (Drug)
Cohort 2: AGN-199201 Dose A and AGN-190584 Dose A
Fixed combinations of AGN-199201 Dose A and AGN-190584 Dose A dosed in both eyes administered once daily during office visits 1 through 5.
干预措施: AGN-199201 ophthalmic solution (Drug)
Cohort 2: AGN-199201 Dose A and AGN-190584 Dose A
Fixed combinations of AGN-199201 Dose A and AGN-190584 Dose A dosed in both eyes administered once daily during office visits 1 through 5.
干预措施: AGN-190584 ophthalmic solution (Drug)
Cohort 3: AGN-199201 Dose B and AGN-190584 Dose B
Fixed combinations of AGN-199201 Dose B and AGN-190584 Dose B dosed in both eyes administered once daily during office visits 1 through 5.
干预措施: AGN-199201 ophthalmic solution (Drug)
Cohort 3: AGN-199201 Dose B and AGN-190584 Dose B
Fixed combinations of AGN-199201 Dose B and AGN-190584 Dose B dosed in both eyes administered once daily during office visits 1 through 5.
干预措施: AGN-190584 ophthalmic solution (Drug)
Cohort 4: AGN-199201 Dose C and AGN-190584 Dose C
Fixed combinations of AGN-199201 Dose C and AGN-190584 Dose C dosed in both eyes administered once daily during office visits 1 through 5.
干预措施: AGN-199201 ophthalmic solution (Drug)
Cohort 4: AGN-199201 Dose C and AGN-190584 Dose C
Fixed combinations of AGN-199201 Dose C and AGN-190584 Dose C dosed in both eyes administered once daily during office visits 1 through 5.
干预措施: AGN-190584 ophthalmic solution (Drug)
Cohort 5: Vehicle, AGN-199201 Dose C and AGN-190584 Dose C
Dominant eye dosed with Vehicle. Fixed combinations of AGN-199201 Dose C and AGN-190584 Dose C dosed in nondominant eye. Treatment administered once daily during office visits 1 through 5.
干预措施: AGN-199201 ophthalmic solution (Drug)
Cohort 5: Vehicle, AGN-199201 Dose C and AGN-190584 Dose C
Dominant eye dosed with Vehicle. Fixed combinations of AGN-199201 Dose C and AGN-190584 Dose C dosed in nondominant eye. Treatment administered once daily during office visits 1 through 5.
干预措施: AGN-190584 ophthalmic solution (Drug)
Cohort 5: Vehicle, AGN-199201 Dose C and AGN-190584 Dose C
Dominant eye dosed with Vehicle. Fixed combinations of AGN-199201 Dose C and AGN-190584 Dose C dosed in nondominant eye. Treatment administered once daily during office visits 1 through 5.
干预措施: AGN-199201 Vehicle (Drug)
Cohort 5: Vehicle, AGN-199201 Dose C and AGN-190584 Dose C
Dominant eye dosed with Vehicle. Fixed combinations of AGN-199201 Dose C and AGN-190584 Dose C dosed in nondominant eye. Treatment administered once daily during office visits 1 through 5.
干预措施: AGN-190584 Vehicle (Drug)
结局指标
主要结局
Weighted Average Change From Baseline in Uncorrected Near Visual Acuity (UNVA) Letters in the Nondominant Eye
时间窗: Baseline, Day 28
UNVA is assessed without corrective lenses in the non-dominant eye. UNVA is measured using an eye chart and is reported as the number of lines read correctly. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of lines read correctly means that vision has improved.
次要结局
- Number of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs)(up to 65 days)