Evaluation of Nanodropper-mediated Microdrops vs. Standard Drops of 0.5% Proparacaine HCl
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Corneal Anesthesia
研究概览
简要总结
The goal of this clinical trial is to compare the onset and duration of numbness of the surface of the eye following the administration of numbing drops, called proparacaine, using either a standard eye drop bottle or a "Nanodropper" adaptor. The Nanodropper is designed to administer smaller-sized drops, or microdrops.
Participants will:
- Complete a baseline eye exam.
- Receive a numbing drop using a standard dropper in one eye and the Nanodropper in the other eye.
- Have their eyes tested for numbness at specific time points (30 seconds, 1, 2, 5, and 10 minutes after getting the drops).
- Tell the researchers if they feel pain during the eye sensation tests.
- Complete a survey about their experience with the eyedrops and testing procedure.
This study could help us find a way to use less medication while still effectively administering eye medications, potentially saving money and reducing medical waste.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Triple (Participant, Investigator, 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
- •Ability to provide informed consent for topical anesthesia delivery
- •Ability to verbally respond to pain
- •At least 18 years of age
排除标准
- •Have a contraindication to local anesthetics
- •History of intravitreal injections
- •History of ocular surgery
- •History of vitreous or retinal surgery
- •Preexisting diagnosis of ocular surface disease requiring punctal plug placement
- •Evidence of any current ocular inflammation
- •Any previous ocular condition (i.e., neurotrophic keratitis, herpetic eye disease, presence of a corneal graft, etc.) that has permanently altered the native sensation of the ocular surface
- •Use of contact lenses in the past 2 weeks
- •Use of exclusionary medications: Topical steroid drops, non-steroidal anti-inflammatory drops, intraocular pressure lowering eye drops, any anti-viral medications used for herpes, opioids
研究组 & 干预措施
Standard Eye Drops
Eyes randomized to this arm will receive a standard drop of 0.5% proparacaine HCl
干预措施: Standard Eye Drop Bottle with Proparacaine HCl 0.5% (Combination Product)
Nanodropper
Eyes randomized to this arm will receive a Nanodropper-mediated microdrop of 0.5% proparacaine HCl
干预措施: Nanodropper and Proparacaine HCl 0.5% (Combination Product)
结局指标
主要结局
Corneal Anesthesia
时间窗: 5 minutes
The primary outcome is the percent or proportion of subjects that achieve anesthesia at the 5-minute time point
次要结局
- Mean time to no pain/anesthesia onset(10 minutes)
- Mean duration of anesthetic effect(10 minutes)
- Patient-Reported Outcomes(30 minutes)
研究者
Aakriti G. Shukla
Associate Professor of Ophthalmology
Columbia University