A Study Evaluating Pupil Dilation Speed With the Micro-Array Print (MAP) Dispenser Comparing 2 Dosing Regimens of Tropicamide-Phenylephrine Fixed Combination Ophthalmic Solution
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Mean Change in Pupil Diameter From Baseline
研究概览
简要总结
1 mist or 2 mists of the study drug will be administered to both eyes according to a pre-specified randomization plan to determine the effect on pupil dilation
详细描述
After screening, eligible subjects will be scheduled for 2 treatment visits where either 1 mist or 2 mists of the study drug will be administered to both eyes according to a pre-specified randomization plan. Safety evaluations and efficacy measurements will be performed at specified time intervals thereafter.
Pupil dilation for each treatment will be compared at each time interval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Only 1 mist or 2 mists of the drug will be administered per treatment visit and will occur in a randomized sequence order using on of the two sequences AB or BA where A is 1 mist of the fixed combination and B is 2 mists of the fixed combination
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Photopic screening pupil diameter ≤ 3.5 mm in each eye
排除标准
- •Allergy to phenylephrine hydrochloride, tropicamide, or benzalkonium chloride.
- •Use of benzodiazepines, monoamine oxidase inhibitors, tricyclic antidepressants, anticonvulsants, cholinergic drug at screening or anticipated during the study period.
- •History of closed-angle glaucoma.
- •Anatomically narrow anterior chamber angles (Van Herrick grade ≤ 2 in either eye).
- •Ocular surgery or laser treatment of any kind prior to the Screening Visit.
- •History of iris trauma, surgery, or atrophy.
- •Irregularly-shaped pupil secondary to ocular trauma or congenital defect, or history of neurogenic pupil disorder.
研究组 & 干预措施
Sequence AB
Sequence AB: 1 mist of tropicamide-phenylephrine fixed combination solution administered to each eye with the Micro Array Print (MAP) Dispenser followed by 2 mists of tropicamide-phenylephrine fixed combination solution administered to each eye with the MAP Dispenser
干预措施: tropicamide-phenylephrine fixed combination ophthalmic solution (Drug)
Sequence BA
Sequence BA: 2 mists of tropicamide-phenylephrine fixed combination solution administered to each eye with the Micro Array Print (MAP) Dispenser followed by 1 mist of tropicamide-phenylephrine fixed combination solution administered to each eye with the MAP Dispenser
干预措施: tropicamide-phenylephrine fixed combination ophthalmic solution (Drug)
结局指标
主要结局
Mean Change in Pupil Diameter From Baseline
时间窗: 35 minutes post drug administration
The primary performance endpoint is Mean Change in pupil diameter at 35 minutes versus per-visit baseline, as measured by digital pupillometry in highly photopic conditions. The highly photopic condition was established using a fully-charged transilluminator (muscle light) at the brightest setting.
次要结局
未报告次要终点