Efficacy of Nanodropper-mediated Topical Anesthetic

Phase 4

Recruiting

• Conditions: Corneal Diseases; Effectiveness of Microdrops

• Registration Number: NCT06636708
• Lead Sponsor: Columbia University

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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-08
• Study First Submitted QC: 2024-10-08
• Study First Posted: 2024-10-15
• Study Start: 2024-12-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-01-13
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 41

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 year
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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Corneal Anesthesia	5 minutes	The primary outcome is the percent or proportion of subjects that achieve anesthesia at the 5-minute time point

Secondary Outcome Measures

Name	Time	Method
Mean time to no pain/anesthesia onset	10 minutes	One secondary outcome of this study is the mean time to no pain/anesthesia onset in minutes.
Mean duration of anesthetic effect	10 minutes	One secondary outcome of this study is the mean duration of anesthetic effect in minutes.
Patient-Reported Outcomes	30 minutes	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.

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States