NCT03804268已完成3 期
A Phase 3, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of AGN-190584 in Participants With Presbyopia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 323
- 试验地点
- 36
- 主要终点
- Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 3
研究概览
简要总结
A study to evaluate the efficacy, safety, and pharmacokinetics of pilocarpine hydrochloride (HCl) ophthalmic solution (AGN-190584) when administered bilaterally, once daily for 30 days in participants with presbyopia.
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
- 40 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjective complaints of poor near vision that impact activities of daily living
排除标准
- •History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any intraocular surgery
- •Use of any topical ophthalmic medications, including artificial tears other than the study medications during the study
- •Use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes
- •Corneal abnormalities (including keratoconus, corneal scar, Fuchs' endothelial dystrophy, guttata, or edema) in either eye that are likely to interfere with visual acuity
- •Narrow iridocorneal angles (Shaffer grade ≤2 or lower on gonioscopy examination), history of angle-closure glaucoma, or previous iridotomy
- •Diagnosis of any type of glaucoma or ocular hypertension
研究组 & 干预措施
Vehicle
Placebo Comparator
Participants received one drop of vehicle in each eye, once daily, for up to 30 days.
干预措施: Vehicle (Other)
Pilocarpine HCl Ophthalmic Solution
Experimental
Participants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days.
干预措施: Pilocarpine HCl Ophthalmic Solution (Drug)
结局指标
主要结局
Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 3
时间窗: Baseline (Day 1) to Day 30 (Hour 3)
Visual acuity for near (40 centimeters (cm)) target was measured in mesopic conditions using an eye chart. Mesopic condition was defined as low lighting 3.2 to 3.5 candelas per square meter (cd/m\^2) measured at the target. Percentage of participants with 3 lines or more improvement from Baseline in mesopic, high-contrast DCNVA are reported.
次要结局
- Percentage of Participants Gaining 3-lines or More in Mesopic, High-contrast, Binocular, DCNVA at Day 30, Hour 10(Baseline (Day1) to Day 30 (Hour 10))
- Percentage of Participants Achieving 20/40 or Better in Photopic, High-contrast, Binocular, DCNVA at Day 30, Hour 1(Day 30 (Hour 1))
- Mean Change From Baseline in Mesopic Near Vision Presbyopia Task-based Questionnaire (NVPTQ) Performance Score at Day 30, Hour 3(Baseline (Day 1) to Day 30 (Hour 3))
- Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 6(Baseline (Day 1) to Day 30 (Hour 6))
- Percentage of Participants Gaining 3-lines or More in Mesopic, High-contrast, Binocular, DCNVA at Day 30, Hour 8(Baseline (Day 1) to Day 30 (Hour 8))
- Change From Baseline in Mesopic, High-contrast, Binocular DCNVA Letters at Day 30, Hour 0.5(Baseline (Day 1) to Day 30 (Hour 0.5))
- Change From Baseline in Photopic, High-contrast, Binocular Distance-corrected Intermediate Visual Acuity (DCIVA) Letters at Day 30, Hour 3(Baseline (Day 1) to Day 30 (Hour 3))
- Mean Change From Baseline in Presbyopia Impact and Coping Questionnaire (PICQ) Coping Score at Day 30, Hour 3(Baseline (Day 1) to Day 30 (Hour 3))
- Change From Baseline in Mesopic, High-contrast, Binocular DCNVA Letters at Day 30, Hour 0.25(Baseline (Day 1) to Day 30 (Hour 0.25))
- Percentage of Participants Achieving 20/40 or Better in Photopic, High-contrast, Binocular, DCNVA at Day 30, Hour 3(Day 30 (Hour 3))
- Mean Change From Baseline in PICQ Impact Score at Day 30, Hour 3(Baseline (Day 1) to Day 30 (Hour 3))
- Mean Change From Baseline in Mesopic NVPTQ Satisfaction Score at Day 30, Hour 3(Baseline (Day 1) to Day 30 (Hour 3))
研究者
研究点 (36)
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