Efficacy of Nanodropper-mediated Topical Anesthetic

Evaluation of Nanodropper-mediated Microdrops vs. Standard Drops of 0.5% Proparacaine HCl

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.

Study Overview

• Status: Completed
• Conditions: Corneal Diseases; Effectiveness of Microdrops
• Intervention / Treatment: Combination product: Standard Eye Drop Bottle with Proparacaine HCl 0.5%; Combination product: Nanodropper and Proparacaine HCl 0.5%

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 2 weeks
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Eye Drops; 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%; This intervention involves administration of proparacaine HCl 0.5% using a standard eye drop bottle.
Experimental: Nanodropper; Eyes randomized to this arm will receive a Nanodropper-mediated microdrop of 0.5% proparacaine HCl	Combination product: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal Anesthesia	The primary outcome is the percent or proportion of subjects that achieve anesthesia at the 5-minute time point	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean time to no pain/anesthesia onset	One secondary outcome of this study is the mean time to no pain/anesthesia onset in minutes.	10 minutes
Mean duration of anesthetic effect	One secondary outcome of this study is the mean duration of anesthetic effect in minutes.	10 minutes
Patient-Reported Outcomes	One secondary outcome of this study includes the patient-reported outcomes related to the subjective experience of having conventional or microdrops of proparacaine instilled, undergoing corneal sensation testing as assessed via a patient survey.	30 minutes

Collaborators and Investigators

• Sponsor: Columbia University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2024
• Primary Completion (Actual): April 24, 2025
• Study Completion (Actual): April 24, 2025

Study Registration Dates

• First Submitted: October 8, 2024
• First Submitted That Met QC Criteria: October 8, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Nanodropper; Corneal anesthesia
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Pharmaceutical Solutions; Ophthalmic Solutions; Proxymetacaine; Propoxycaine
• Other Study ID Numbers: AAAU9824

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes