RecruitingPhase 4NCT05663684

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?


Sponsor

Louisiana State University Health Sciences Center in New Orleans

Enrollment

145 participants

Start Date

Jun 30, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria4

  • 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

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Interventions

DRUGProparacaine Hydrochloride ophthalmic solution, USP 0.5%

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

DRUGBalanced salt solution

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


Locations(1)

Louisiana State University Health Sciences Center

New Orleans, Louisiana, United States

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NCT05663684


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