NCT03782701已完成4 期
The Effect of Lumify™ (Brimonidine Tartrate Ophthalmic Solution 0.025%) on Palpebral Fissure Height
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Palpebral Fissure Height
研究概览
简要总结
The purpose of the research is to see if Lumify™ has an effect on eyelid position.
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
- 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
- 是
入选标准
- •Adults age 18 and above able to provide informed consent to participate
- •Subject with stable ocular health, defined as no ocular conditions requiring ongoing topical therapy or recent surgical intervention
排除标准
- •Adults unable to consent
- •Prisoners
- •Pregnant women.
- •Known contradictions or sensitivities to study medication (brimonidine)
- •Ocular surgery within the past 3 months or refractive surgery within the past six months
- •Grossly abnormal lid margins, anatomical abnormalities, previous eyelid or orbital surgery
- •Variable ptosis or eyelid position (e.g., myasthenia gravis, thyroid eye disease, or blepharospasm)
- •Significant pre-existing ptosis of any cause (defined as margin reflex distance 1 < 1mm)
- •Any ocular or systemic condition that, in the opinion of the investigator, would confound study data, interfere with the subject's study participation, or affected the subject's safety or trial parameters
- •Presence of an active ocular infection
- •Prior (within 5 days of beginning study treatment) use of eye whiteners (eg, vasoconstrictors), decongestants, antihistamines (including over the counter and herbal topical ophthalmic medications), phenylephrine dilating drops, any other topical ophthalmic agents
- •Inability to sit comfortably for 15 - 30 minutes
研究组 & 干预措施
Lumify Eye Drop
Active Comparator
Participants will be randomized to receive a single drop of Lumify to either the left or right eye.
干预措施: Brimonidine tartrate ophthalmic solution 0.025% (Drug)
Saline Solution Eye Drop
Active Comparator
Participants will be randomized to receive a single drop of sterile balanced saline solution to either the left or right eye.
干预措施: Sterile balanced saline solution (Other)
结局指标
主要结局
Palpebral Fissure Height
时间窗: Baseline, 5, 15 and 30 minutes after application
Objective measurement of distance between inner margin of upper and lower eyelids from clinical photographs.
次要结局
- Intraocular Pressure(Baseline, 5, 15 and 30 minutes after application)
- Eye Redness(Baseline, 5, 15 and 30 minutes after application)
- Eye Discomfort(Baseline, 5, 15 and 30 minutes after application)
研究者
Wendy Lee
Associate Professor of Ophthalmology and Dermatology
University of Miami
研究点 (1)
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