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

Does Administration of Proparacaine Hydrochloride 0.5% Ophthalmic Solution Prior to Canalicular Probing and Irrigation Decrease Patient Discomfort?

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.

Study Overview

• Status: Recruiting
• Conditions: Epiphora; Dacryostenosis; Dacryocystitis
• Intervention / Treatment: Drug: Proparacaine Hydrochloride ophthalmic solution, USP 0.5%; Drug: Balanced salt solution

Detailed Description

Rationale: It is common for male and female adults of all races with a chief complaint of epiphora (excessive tearing) to express discomfort either verbally or through body language while undergoing tear duct (canalicular) probing and irrigation even when no pathology is detected. Use of a topical anesthetic during canalicular probing and irrigation is seen in children but has yet to be formally investigated in adults to date. The goal of this study is to identify whether or not instillation of a drop of Proparacaine hydrochloride 0.5% ophthalmic solution into a participant's eye prior to performance of probing and irrigation will improve participant comfort during the procedure and is therefore recommended.

Hypothesis: Administration of a drop of Proparacaine hydrochloride 0.5% ophthalmic solution into the eye prior to probing and irrigation of the lower lid canalicular system will decrease discomfort as compared to a control drop of BSS ophthalmic solution into the opposite eye prior to the same procedure.

Null hypothesis: Administration of a drop of Proparacaine hydrochloride 0.5% ophthalmic solution does not have an effect on discomfort during canalicular probing and irrigation.

Medication: Proparacaine hydrochloride ophthalmic solution, United States Pharmacopeia (USP) 0.5% is a local anesthetic drug intended for topical ophthalmic use. Proparacaine Hydrochloride ophthalmic solution is a fast-acting anesthetic lasting 10-20 minutes. Proparacaine hydrochloride ophthalmic solution, USP 0.5% is FDA approved for this indication.

Probing and irrigation: A common in-office ophthalmic procedure performed with a small gauge, blunt tube on a syringe filled with BSS. The cannula is placed into the canaliculus (tear duct) of one eyelid, and the BSS is used to irrigate the lacrimal system. This procedure identifies whether or not obstruction of the lacrimal system is present. A participant with an open (patent) system will taste the salty BSS solution in the nose. A participant with a nasolacrimal duct obstruction (NLDO) or a more proximal canalicular obstruction will have reflux of the irrigant out of the opposite lid (on the same side) canaliculus, the probed canaliculus, or both and will usually not detect any irrigant within the nasopharynx.

Definitions:

Nasolacrimal drainage system: The physiologic apparatus which drains tears from the surface of the eye into the nose (i.e. the tear drain). It consists of (from eye to nose) the punctum (opening of the tube), the canaliculus (a thin tube within the eyelid), the lacrimal sac (a sac that hold the tears that lies within the bone of the nose) and finally the nasolacrimal duct (a duct that connects the lacrimal sac (-lacrimal) into the nose (naso-). A blockage anywhere along this pathway can cause epiphora.

Epiphora: The pathological process of tears overflowing from the ocular surface and rolling down the face. Commonly caused by obstructions of the lacrimal drainage system. Can cause significant irritation and loss of visio

• Study Type: Interventional
• Enrollment (Anticipated): 145
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Austin M Pharo, MD; Phone Number: (504) 568-3156; Email: apharo@lsuhsc.edu

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Recruiting
      • Louisiana State University Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants with obstruction of the lacrimal system; 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%; One drop instilled in one eye, randomly chosen, as topical anesthetic; Other Names: Alcaine; Drug: Balanced salt solution; One drop instilled in one eye, randomly chosen, as control placebo; Other Names: BSS
Experimental: Participants with no obstruction of the lacrimal system; 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%; One drop instilled in one eye, randomly chosen, as topical anesthetic; Other Names: Alcaine; Drug: Balanced salt solution; One drop instilled in one eye, randomly chosen, as control placebo; Other Names: BSS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Louisiana State University Health Sciences Center in New Orleans
• Investigators: Principal Investigator: Austin M Pharo, MD, LSU Health Sciences Center

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2020
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): January 31, 2023

Study Registration Dates

• First Submitted: December 15, 2022
• First Submitted That Met QC Criteria: December 15, 2022
• First Posted (Estimate): December 23, 2022

Study Record Updates

• Last Update Posted (Estimate): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 15, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Nasolacrimal duct obstruction; Probe and irrigation
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dacryocystitis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Proxymetacaine; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: LSU1351

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes