Comparative Effect of Oxymetazoline 0.1% (Upneeq) and Brimonidine 0.025% (Lumify) on Upper Eyelid Position in Acquired Ptosis: A Randomized, Double-Masked, Crossover Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Change in upper-eyelid height (MRD1) (Upneeq vs. Lumify)
研究概览
简要总结
This study aims to compare the short-term effect of oxymetazoline 0.1% (Upneeq) versus brimonidine 0.025% (Lumify) on upper-eyelid position in adults with acquired ptosis. Participants will undergo standardized eyelid photography, receive a single dose of either Upneeq or Lumify in randomized order, and have repeat photographs approximately 60 minutes later. They will return for a second visit to receive the alternate medication using the same procedures. Eyelid height measurements will be obtained from coded images by masked graders. Data will be analyzed using paired statistical methods appropriate for a crossover design. Both medications are FDA-approved topical ophthalmic drops, and the study involves minimal risk with anticipated transient ocular irritation as the most common adverse event.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Adults age ≥18 years
- •Acquired ptosis with MRD1 ≤ 2.5 mm in at least one eye
- •Ability to complete both study visits (≥48 hours apart)
- •Fluent in English
- •Able to provide informed consent
排除标准
- •Congenital ptosis or mechanical ptosis due to mass effect
- •Ocular surgery within the past 6 months
- •Significant active ocular surface disease
- •Current contact lens wear on study days
- •Known allergy to oxymetazoline or brimonidine
- •Use of MAO inhibitors, α-blockers, or contraindicated medications
- •Pregnancy or lactation
- •Significant uncontrolled cardiovascular disease
- •Any condition that may interfere with study procedures or data reliability
研究组 & 干预措施
Upneeq First, then Lumify
Participants receive oxymetazoline 0.1% (Upneeq) at Visit 1 and brimonidine 0.025% (Lumify) at Visit 2.
干预措施: Oxymetazoline 0.1% (Upneeq) (Drug)
Upneeq First, then Lumify
Participants receive oxymetazoline 0.1% (Upneeq) at Visit 1 and brimonidine 0.025% (Lumify) at Visit 2.
干预措施: Brimonidine 0.025% (Lumify) (Drug)
Lumify First, then Upneeq
Participants receive brimonidine 0.025% (Lumify) at Visit 1 and oxymetazoline 0.1% (Upneeq) at Visit 2.
干预措施: Oxymetazoline 0.1% (Upneeq) (Drug)
Lumify First, then Upneeq
Participants receive brimonidine 0.025% (Lumify) at Visit 1 and oxymetazoline 0.1% (Upneeq) at Visit 2.
干预措施: Brimonidine 0.025% (Lumify) (Drug)
结局指标
主要结局
Change in upper-eyelid height (MRD1) (Upneeq vs. Lumify)
时间窗: 60 minutes after instillation
Change in MRD1 at \~60 minutes after drop instillation (Upneeq vs. Lumify)
次要结局
- Change in palpebral fissure height (PFH)(60 minutes after instillation)
- Number of participants with Conjunctival redness(60 minutes after each medication)
- Participant-reported improvement in eyelid elevation or visual function(60 minutes after each medication)
- Frequency of Adverse Events(60 minutes after each medication)