Efficacy of Nanodropper-mediated Topical Anesthetic

Columbia University

Status and phase: Completed; Phase 4

Conditions: Corneal Diseases; Effectiveness of Microdrops

Treatments: Combination Product: Nanodropper and Proparacaine HCl 0.5%; Combination Product: Standard Eye Drop Bottle with Proparacaine HCl 0.5%

Study type: Interventional

Funder types: Other

Identifiers

NCT06636708

AAAU9824

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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56 participants in 2 patient groups

Standard Eye Drops

Active Comparator group

Description:

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

Treatment:

Combination Product: Standard Eye Drop Bottle with Proparacaine HCl 0.5%

Nanodropper

Experimental group

Description:

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

Treatment:

Combination Product: Nanodropper and Proparacaine HCl 0.5%