A Double-Blind, Randomized, Placebo-Controlled, Single-Dose, Parallel Study to Assess the Effects of Avanafil (STENDRA™) on Multiple Parameters of Vision, Including, But Not Limited to Visual Acuity, Intraocular Pressure, Pupillometry, and Color Vision Discrimination, in Healthy Male Subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- VIVUS LLC
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change From Baseline in Pupil Dilation 1 Hour Post Dosing
研究概览
简要总结
The purpose of this study is to see if Stendra causes any changes in vision, eye pressure, pupil dilation, and color vision in healthy males.
详细描述
The objectives of this study are to assess the effect of Stendra on visual acuity, intraocular pressure, pupillometry, and color vision discrimination in healthy male subjects.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy adult males 18 to 45 years of age, inclusive
- •Non-tobacco user for at least 6 months prior to first dose
排除标准
- •History or presence of retinal disease or any vision defects including color vision
- •Intraocular pressure value ≥ 22mm Hg
- •Resting heart rate < 45 or > 90 beats per minute (3 rechecks)
- •Systolic blood pressure < 90 or > 140 mm Hg or Diastolic blood pressure < 50 or >90 mm Hg (3 rechecks)
- •Initiation or change in dose of any α-blockers 14 days prior to randomization
研究组 & 干预措施
Active
Stendra 200 mg
干预措施: Stendra 200 mg (Drug)
Active
Stendra 200 mg
干预措施: Placebo (Drug)
Placebo
placebo
干预措施: Stendra 200 mg (Drug)
Placebo
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Pupil Dilation 1 Hour Post Dosing
时间窗: 1 hour
Pupil dilation was measured using the Neuroptics Model VIP 200 pupillometer under standard lighting conditions.
Change From Baseline in Intraocular Pressure 1 Hour Post Dosing
时间窗: 1 hour
Intraocular Pressure was measured using the Goldman applanation tonometry
Change From Baseline in Color Vision Discrimination 1 Hour Post Dosing
时间窗: 1 hour
Color vision discrimination was performed using the Lanthony 40-Hue Test according to Farnsworth-Munsell 100-Hue Test. The total error score was derived by counting the number of caps misplaced.
Change From Baseline in Visual Acuity 1 Hour Post Dosing
时间窗: 1 hour
Visual acuity was measured using the Logarithm of the Minimum Angle Resolution (LogMAR) chart. The LogMAR value of the best line read was noted and the number of letters read in the next row was multiplied by 0.02, then subtracted from the LogMAR value of the best line completely read.
次要结局
- Change From Baseline in Color Vision Discrimination 24 Hour Post Dosing(24 hours)
- Change From Baseline in Intraocular Pressure 24 Hour Post Dosing(24 hours)
- Change From Baseline in Visual Acuity 24 Hours Post Dosing(24 hours)
- Change From Baseline in Pupil Dilation 24 Hour Post Dosing(24 hour)