Clinical trial NCT06636708: Efficacy of Nanodropper-mediated Topical Anesthetic
Official title: Evaluation of Nanodropper-mediated Microdrops vs. Standard Drops of 0.5% Proparacaine HCl
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Corneal Diseases
Effectiveness of Microdrops
Keywords: Corneal anesthesia
Nanodropper
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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:

1. Complete a baseline eye exam.
2. Receive a numbing drop using a standard dropper in one eye and the Nanodropper in the other eye.
3. Have their eyes tested for numbness at specific time points (30 seconds, 1, 2, 5, and 10 minutes after getting the drops).
4. Tell the researchers if they feel pain during the eye sensation tests.
5. 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.


Eligibility criteria: Inclusion Criteria:

1. Ability to provide informed consent for topical anesthesia delivery
2. Ability to verbally respond to pain
3. At least 18 years of age

Exclusion Criteria:

1. Have a contraindication to local anesthetics
2. History of intravitreal injections
3. History of ocular surgery
4. History of vitreous or retinal surgery
5. Preexisting diagnosis of ocular surface disease requiring punctal plug placement
6. Evidence of any current ocular inflammation
7. 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
8. Use of contact lenses in the past year
9. 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

Primary outcomes:
measure: Corneal Anesthesia
timeFrame: 5 minutes
Secondary outcomes:
measure: Mean time to no pain/anesthesia onset
timeFrame: 10 minutes
measure: Mean duration of anesthetic effect
timeFrame: 10 minutes
measure: Patient-Reported Outcomes
timeFrame: 30 minutes
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
References:
citation: St Peter DM, Steger JS, Patnaik JL, Davis N, Kahook MY, Seibold LK. Reduction of Eyedrop Volume for Topical Ophthalmic Medications with the Nanodropper Bottle Adaptor. Med Devices (Auckl). 2023 Apr 6;16:71-79. doi: 10.2147/MDER.S397654. eCollection 2023.
citation: Palmer DJ, Robin AL, McCabe CM, Chang DF; Ophthalmic Instrument Cleaning and Sterilization Task Force. Reducing topical drug waste in ophthalmic surgery: multisociety position paper. J Cataract Refract Surg. 2022 Sep 1;48(9):1073-1077. doi: 10.1097/j.jcrs.0000000000000975.
citation: Moore DB, Walton C, Moeller KL, Slabaugh MA, Mudumbai RC, Chen PP. Prevalence of self-reported early glaucoma eye drop bottle exhaustion and associated risk factors: a patient survey. BMC Ophthalmol. 2014 Jun 13;14:79. doi: 10.1186/1471-2415-14-79.