NCT06217796已完成4 期
A Single-Center, Open Label, Phase 4 Study of the Safety and Efficacy of Fixed Combination Phenylephrine 2.5%-Tropicamide 1% Ophthalmic Solution (Mydcombi®) Administered With the Mydcombi Dispenser for Pupil Dilation (THE MIST-2.1 STUDY)
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Mean Change in Pupil Diameter
研究概览
简要总结
Subjects will receive ½ of the approved dose of MydCombi to determine the dilation curve with the reduced dose.
详细描述
MydCombi is approved for inducing mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired. The approved dose is 1 metered spray to the cornea of each eye to be dilated to be repeated after 5 minutes. This study will define the dilation of the pupil with ½ of the approved dose - a single metered spray to the cornea of each eye.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide signed written consent prior to participation in any study-related procedures.
- •Ability to return for the study treatment visit.
- •Photopic screening pupil diameter ≤ 3.5 mm in each eye.
- •Females not of childbearing potential or negative pregnancy test
排除标准
- •Pregnant or Lactating
- •Clinically significant abnormalities of the eye
- •Active eye disease
- •Using medication that can effect pupil dilation
研究组 & 干预措施
Open Label Treatment
Other
Single metered spray
干预措施: MydCombi (Combination Product)
结局指标
主要结局
Mean Change in Pupil Diameter
时间窗: 30 minutes
Mean change in pupil diameter at 30 minutes from the time of drug dose versus baseline, as measured by digital pupillometry in highly photopic conditions
次要结局
- 6.0 mm or Greater at 30 Minutes(30 minutes)
- Distribution of Pupil Diameters(360 minutes)
- 7.0 mm or Greater at 30 Minutes(30 minutes)
研究者
研究点 (1)
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