Efficacy of Nanodropper-mediated Topical Anesthetic

Last updated: January 10, 2025
Sponsor: Columbia University
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

Nanodropper and Proparacaine HCl 0.5%

Standard Eye Drop Bottle with Proparacaine HCl 0.5%

Clinical Study ID

NCT06636708
AAAU9824
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

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

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 sensationof the ocular surface

  8. Use of contact lenses in the past year

  9. Use of exclusionary medications: Topical steroid drops, non-steroidalanti-inflammatory drops, intraocular pressure lowering eye drops, any anti-viralmedications used for herpes, opioids

Study Design

Total Participants: 41
Treatment Group(s): 2
Primary Treatment: Nanodropper and Proparacaine HCl 0.5%
Phase: 4
Study Start date:
December 12, 2024
Estimated Completion Date:
December 01, 2025

Connect with a study center

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

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