NCT06636708

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2024

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

December 12, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2025

Completed
Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

October 8, 2024

Last Update Submit

February 10, 2026

Conditions

Effectiveness of MicrodropsCorneal Diseases

Keywords

Corneal anesthesiaNanodropper

Outcome Measures

Primary Outcomes (1)

  • Corneal Anesthesia

    The primary outcome is the percent or proportion of subjects that achieve anesthesia at the 5-minute time point

    5 minutes

Study Arms (2)

Standard Eye Drops

ACTIVE COMPARATOR

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

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

Nanodropper

EXPERIMENTAL

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

Combination Product: Nanodropper and Proparacaine HCl 0.5%

Interventions

Nanodropper and Proparacaine HCl 0.5%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.

Nanodropper
Standard Eye Drop Bottle with Proparacaine HCl 0.5%COMBINATION_PRODUCT

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

Standard Eye Drops

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to provide informed consent for topical anesthesia delivery
  • Ability to verbally respond to pain
  • At least 18 years of age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (3)

  • 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.

    PMID: 37056302BACKGROUND

  • 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.

    PMID: 35608314BACKGROUND

  • 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.

    PMID: 24927769BACKGROUND

MeSH Terms

Conditions

Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Ophthalmology

Study Record Dates

First Submitted

October 8, 2024

First Posted

October 15, 2024

Study Start

December 12, 2024

Primary Completion

April 24, 2025

Study Completion

April 24, 2025

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)