The Effect of Upneeq (Oxymetazoline Hydrochloride 0.1%) on Palpebral Fissure Height, Eye Redness, and Patient-reported Eye Appearance
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Change in Palpebral Fissure Height
研究概览
简要总结
The purpose of the research is to see if Upneeq ( oxymetazoline 0.1% ophthalmic solution) has an effect on eyelid position, eye redness, or patient-perceived appearance of the eyes.
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, Care Provider, Outcomes Assessor)
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
- •Individuals less than 18 years of age
- •Prisoners
- •Pregnant women.
- •Known contradictions or sensitivities to study medication (oxymetazoline)
- •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)
- •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
Upneeq Group
Participants in this group will receive a one-time dosing of oxymetazoline hydrochloride 0.1% (1 drop applied to ocular surface of each eye of patients in the treatment group)
干预措施: Oxymetazoline hydrochloride 0.1% ophthalmic solution (Drug)
Control Group
Participants in this group will receive a one-time dosing of balanced saline solution (1 drop applied to ocular surface of each eye of patients in the control group)
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Palpebral Fissure Height
时间窗: Baseline, Day 1
Palpebral fissure height will be calculated from the sum of marginal reflex distance 1 and 2 measured from the photograph by Ipad software and recorded by investigators before and after drop instillation.
次要结局
- Change in Patient-reported Eye Appearance - FACE-Q Eye Appearance(Baseline, Day 1)
- Change in Patient-reported Eye Appearance - FACE-Q Upper Eyelid Appearance(Baseline, Day 1)
- Change in Eye Redness as Measured by the Validated Bulbar Redness Grading Scale(Baseline, Day 1)
研究者
Wendy Lee
Associate Professor of Ophthalmology and Dermatology
University of Miami