A Randomized, Placebo-controlled, Double-masked, Multi-center, Dose-ranging Study to Evaluate the Safety, and Efficacy of UNR844 in Subjects With Presbyopia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- Characterize Dose-response of UNR844 for Change From Baseline in Binocular Distance-corrected Near Visual Acuity (DCNVA) at Month 3
研究概览
简要总结
Study of safety and efficacy of UNR844 in subjects with presbyopia.
详细描述
This was a randomized, placebo-controlled, double-masked,multi-arm, parallel-group, multi-center 13-month study which consisted of:
- A 1 week run-in period
- A 3-month treatment course with UNR844 and/or Placebo
- A 9-month treatment holiday period Participants were randomized equally to one of five treatment arms: UNR844 5 mg/mL,UNR844 13.3 mg/mL, UNR844 23 mg/mL, UNR844 30 mg/mL, or Placebo eye drops twice-a-day for three months.
Participants underwent a 1 week run-in period where they were assessed for entry criteria during the Screening visit. During the run-in period, participants self-administered 1 drop of artificial tears twice-a-day (1 drop in the morning and 1 drop in the evening) in each eye at home. This run-in period was designed to help minimize any potential variability in distance corrected near visual acuity (DCNVA) caused due to initial ocular surface issues and help to establish an accurate baseline prior to randomization. The run-in period was to help exclude participants with a change in DCNVA of 0.10 logMAR difference between Screening and Baseline.
This study was conducted to determine the optimum dose of UNR844 treatment and the duration of effect of UNR844 treatment for further development.
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
- 45 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be obtained before any assessment is performed
- •Impaired near vision in each eye and when using both eyes, without any near correction
- •Need a certain level of near correction
排除标准
- •Impaired distance vision in either eye, with distance correction (if any)
- •Severe short- or long-sightedness
- •Any significant medical or clinical conditions affecting vision, the eyes or general health
研究组 & 干预措施
UNR844 23 mg/mL
UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months
干预措施: UNR844 (Drug)
UNR844 5 mg/mL
UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months
干预措施: UNR844 (Drug)
UNR844 13.3 mg/mL
UNR844 13.3 mg/mL 1 ophthalmic solution; one drop twice-a-day for three months
干预措施: UNR844 (Drug)
UNR844 30 mg/mL
UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months
干预措施: UNR844 (Drug)
Placebo Ophthalmic Solution
placebo ophthalmic solution; one drop twice-a-day for three months
干预措施: Placebo (Drug)
结局指标
主要结局
Characterize Dose-response of UNR844 for Change From Baseline in Binocular Distance-corrected Near Visual Acuity (DCNVA) at Month 3
时间窗: Baseline, Month 3
Characterize dose response of UNR844 as measured by change from baseline at Month 3 in binocular DCNVA (without near correction) in Logarithm of Minimum Angle of Resolution (logMAR), at 40cm. A low logMAR score represents good vision while a high logMAR score represents bad vision.
次要结局
- Percentage of Participants Gaining at Least 0.30 logMAR in Monocular (Worse-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3(Baseline, Month 3)
- Percentage of Participants Gaining at Least 0.30 logMAR in Monocular (Better-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3(Baseline, Month 3)
- Characterize Dose Response of UNR844 as Measured by Change From Baseline in Monocular (Better-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) at Month 3(Baseline, Month 3)
- Percentage of Participants Gaining at Least 0.30 logMAR in Binocular Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3(Baseline, Month 3)
- Characterize Dose Response of UNR844 as Measured by Change From Baseline in Monocular (Worse-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) at Month 3(Baseline, Month 3)