Does Topical Ophthalmic Anesthetic Prior to Probing and Irrigation Decrease Pain?

NCT04229771 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 2019-216
• Study Type: interventional
• Target: 2
• 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 William Beaumont Hospital - Royal Oak, Michigan outpatient ophthalmology clinic with a chief 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)

• Count of Participants Who Report of Less Discomfort in the Eye That Received the Proparacaine Hydrochloride Anesthetic During Probing

  Participants completed a survey which asked which procedure was more uncomfortable (left or right). Assignment to receive proparacaine hydrochloride was compared to survey results. When the participant reported less discomfort in the eye that received the proparacaine hydrochloride medication, this is is reported as concordance between reduction of pain/discomfort and anesthetic use.

  1 minute

Study Arms (2)

Participants who received proparacaine hydrochloride solution in left eye and placebo in right eye

EXPERIMENTAL

Participants receiving a drop of Proparacaine Hydrocholoride 0.5% ophthalmic solution in left eye and a drop of basic salt solution (BSS, placebo) in the right eye prior to probing and irrigation.

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

Participants who received proparacaine hydrochloride solution in right eye and placebo in left eye

EXPERIMENTAL

Participants receiving a drop of Proparacaine Hydrocholoride 0.5% ophthalmic solution in right eye and a drop of basic salt solution (BSS, placebo) in the left 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 who received proparacaine hydrochloride solution in left eye and placebo in right eye; Participants who received proparacaine hydrochloride solution in right eye and placebo in left eye

Balanced salt solution DRUG

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

Also known as: BSS

Participants who received proparacaine hydrochloride solution in left eye and placebo in right eye; Participants who received proparacaine hydrochloride solution in right eye and placebo in left eye

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 Beaumont Royal Oak or any of the listed physician offices who present with a chief 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

• Corewell Health East: lead

Study Sites (1)

Dianne Schlachter

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Lacrimal Apparatus Diseases; Dacryocystitis; Lacrimal Duct Obstruction

Interventions

proxymetacaine; Hanks Balanced Salt Solution

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Dr. Dianne Schlachter, Staff Physician
• Organization: William Beaumont Hospital

dianne.schlachter@beaumont.org

248-551-2020

Study Officials

• Dianne M Schlachter, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Randomization will be performed by the primary 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 chief investigator will instruct clinic personnel as to which syringe should be labeled "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 by clinical assistants with either left (L) or right (R) as randomized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A double-blinded, randomized, controlled clinical trial with one eye of each participant receiving the experimental treatment and one eye acting as control, receiving placebo

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 18, 2020
• Study Start: June 30, 2020
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: January 19, 2023
• Results First Posted: January 19, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)