MedTrace Logo

Does Topical Ophthalmic Proparacaine 0.5% Prior to Probing and Irrigation Decrease Pain?

NCT05663684 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2022-12-23

No results posted yet for this study

Summary

Purpose: It is unknown whether instillation of a drop of anesthetic ophthalmic solution into the eye such as proparacaine hydrochloride 0.5% prior to probing and irrigation of the tear duct (lacrimal drainage) system improves participant comfort during the procedure. To date, there have been no formal studies evaluating the possible benefit of this pretreatment.

Methods: Participants 18 years and older who present to the Louisiana State University or associated outpatient ophthalmology clinic(s) with a complaint of epiphora (excessive tearing) who necessitate bilateral lower lid probing and irrigation of the lacrimal drainage system will be enrolled in the study. One eye will be randomized to receive a drop of the anesthetic Proparacaine hydrochloride 0.5% and the other eye will receive a control drop of Balanced Salt Solution (BSS). Probing and irrigation will then be performed in the usual fashion. The participant will then be questioned via survey on a pain scale of 1-5 as to the amount of subjective pain experienced on each side during the procedure.

Expected Results: Investigators expect participants will experience statistically significantly less pain in eyes that have received a drop of Proparacaine hydrochloride 0.5% prior to performance of probing and irrigation compared to the eyes which have received the control drop.

Conditions

  • Epiphora
  • Dacryostenosis
  • Dacryocystitis

Interventions

DRUG

Proparacaine Hydrochloride ophthalmic solution, USP 0.5%

One drop instilled in one eye, randomly chosen, as topical anesthetic

DRUG

Balanced salt solution

One drop instilled in one eye, randomly chosen, as control placebo

Sponsors & Collaborators

  • Louisiana State University Health Sciences Center in New Orleans

    lead OTHER

Principal Investigators

  • Austin M Pharo, MD · LSU Health Sciences Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2022-12-30
Completion
2023-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05663684 on ClinicalTrials.gov