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

NCT05663684 | Recruiting Phase 4 FDA Drug

• 1 other identifier: LSU1351
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Nasolacrimal duct obstruction; Probe and irrigation

Outcome Measures

Primary Outcomes (1)

• Association between reduction of pain/discomfort and anesthetic use

  Count of participants who have concordance between instillation of anesthetic and report of less discomfort in that eye during probing

  1 minute

Study Arms (2)

Participants with no obstruction of the lacrimal system

EXPERIMENTAL

Patients will have received a drop of Proparacaine Hydrocholoride 0.5% ophthalmic solution in one eye and a drop of BSS in the other eye prior to probing and irrigation.

Drug: Proparacaine Hydrochloride ophthalmic solution, USP 0.5%; Drug: Balanced salt solution

Participants with obstruction of the lacrimal system

EXPERIMENTAL

Participants who have a blockage in their tear drainage system on probing and irrigation. Participants will have received a drop of Proparacaine Hydrocholoride 0.5% ophthalmic solution in one eye and a drop of BSS in the other eye prior to probing and irrigation.

Drug: Proparacaine Hydrochloride ophthalmic solution, USP 0.5%; Drug: Balanced salt solution

Interventions

Proparacaine Hydrochloride ophthalmic solution, USP 0.5% DRUG

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

Also known as: Alcaine

Participants with no obstruction of the lacrimal system; Participants with obstruction of the lacrimal system

Balanced salt solution DRUG

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

Also known as: BSS

Participants with no obstruction of the lacrimal system; Participants with obstruction of the lacrimal system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants of any sex aged 18 years or older
• Signs and symptoms of epiphora which necessitate performance of a diagnostic probing and irrigation of the bilateral lower eyelid lacrimal drainage system at Louisiana State University Health Sciences Center or any of the listed physician offices who present with a complaint of epiphora from either eye

You may not qualify if:

• A known allergy to topical proparacaine hydrochloride
• Known pre-existing scarring, surgery, radiation to the nasolacrimal system
• Presence of blockage and or reflux on probing and irrigation of either side
• Cognitive Impairment

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead

Study Sites (1)

Louisiana State University Health Sciences Center

New Orleans, Louisiana, 70112, United States

RECRUITING

MeSH Terms

Conditions

Lacrimal Apparatus Diseases; Dacryocystitis; Lacrimal Duct Obstruction

Interventions

proxymetacaine; Hanks Balanced Salt Solution

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Austin M Pharo, MD

  LSU Health Sciences Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Austin M Pharo, MD

CONTACT

(504) 568-3156; apharo@lsuhsc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Randomization will be performed by a secondary investigator who will have no participant interaction during the performance of the procedure and obtainment of the survey responses. A random number generator will be used to obtain either an even or odd number. Odd numbers mean the left eye receives Proparacaine hydrochloride 0.5% ophthalmic solution, even numbers mean the right eye does. The secondary investigator will then label each syringe "L" or "R" depending on randomization results. Two identical 1 ml syringes will be prepared. One syringe containing control BSS, and the other containing Proparacaine hydrochloride 0.5% ophthalmic solution. Each syringe will be labeled with either left (L) or right (R) as randomized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: December 23, 2022
• Study Start: June 30, 2020
• Primary Completion: December 30, 2022
• Study Completion: January 31, 2023
• Last Updated: December 23, 2022

Record last verified: 2022-12

Locations

US (1)