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CompletedNCT06636708Updated Feb 12, 2026

Efficacy of Nanodropper-mediated Topical Anesthetic

A Phase 4 interventional study of Nanodropper and Proparacaine HCl 0.5% and Standard Eye Drop Bottle with Proparacaine HCl 0.5% in Corneal Diseases and Effectiveness of Microdrops, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-12.

Sponsored by Columbia University · Phase 4, Interventional, and Device feasibility

From the registry’s dates

  • Primary completion was Apr 2025, 1 year 5 months ago, and no results have been posted to the registry.
Phase
Phase 4
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Corneal Diseases
  • Effectiveness of Microdrops

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Keywords

  • Corneal anesthesia
  • Nanodropper
03

In context

Corneal Diseases

130 studies on the registry are indexed under Corneal Diseases; 43 are open to participants now.

This study's enrollment of 56 is above the median of 32 across 78 interventional studies indexed under Corneal Diseases.

Browse Corneal Diseases studies →

Lead sponsor

Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.

Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 4
Primary purpose
Device feasibility
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
56 participants (actual)

Study arms

  • 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%

  • 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%

Interventions

  • Combination productNanodropper 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.

  • Combination productStandard Eye Drop Bottle with Proparacaine HCl 0.5%

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

06

What researchers measure

Primary outcomes

  1. Corneal Anesthesia

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

    Time frame: 5 minutes

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Study locations

1 site
  • Columbia University Irving Medical Center
    New York, New York 10032, United States
08

References and documents

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. PubMed 37056302 ↗
  • 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. PubMed 35608314 ↗
  • 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. PubMed 24927769 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06636708
Lead sponsor
Columbia University
Responsible party
Aakriti G. Shukla (Associate Professor of Ophthalmology, Columbia University) — Principal investigator
First posted
Oct 15, 2024
Start date
Dec 12, 2024
Primary completion
Apr 24, 2025
Completion
Apr 24, 2025
Last update
Feb 12, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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