Efficacy of Nanodropper-mediated Topical Anesthetic

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-12

Study Completion Date

2025-04-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Corneal Diseases Effectiveness of Microdrops

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Standard Eye Drops

Eyes randomized to this arm will receive a standard drop of 0.5% proparacaine HCl

Group Type ACTIVE_COMPARATOR

Standard Eye Drop Bottle with Proparacaine HCl 0.5%

Intervention Type COMBINATION_PRODUCT

This intervention involves administration of proparacaine HCl 0.5% using a standard eye drop bottle.

Nanodropper

Eyes randomized to this arm will receive a Nanodropper-mediated microdrop of 0.5% proparacaine HCl

Group Type EXPERIMENTAL

Nanodropper and Proparacaine HCl 0.5%

Intervention Type COMBINATION_PRODUCT

The Nanodropper is an eyedrop bottle adaptor that creates smaller eyedrops by coupling to an existing eyedrop bottle. This intervention involves the administration of proparacaine HCl 0.5% using the Nanodropper.

Interventions

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Nanodropper and Proparacaine HCl 0.5%

The Nanodropper is an eyedrop bottle adaptor that creates smaller eyedrops by coupling to an existing eyedrop bottle. This intervention involves the administration of proparacaine HCl 0.5% using the Nanodropper.

Intervention Type COMBINATION_PRODUCT

Standard Eye Drop Bottle with Proparacaine HCl 0.5%

This intervention involves administration of proparacaine HCl 0.5% using a standard eye drop bottle.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes