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OpenTrials
Completed

NCT Number: NCT06636708

Efficacy of Nanodropper-mediated Topical Anesthetic

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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Key information

Conditions

Corneal Diseases Effectiveness of Microdrops Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Corneal Anesthesia

    Time frame: 5 minutes

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

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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