Recruiting

Proparacaine

Sponsor:

Louisiana State University Health Sciences Center in New Orleans

Code:

NCT05663684

Conditions

Epiphora

Dacryostenosis

Dacryocystitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Proparacaine Hydrochloride ophthalmic solution, USP 0.5%

Balanced salt solution

Study Details

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

Study ID

NCT05663684

Start date

Jun 30, 2020

Status verified date

Dec, 2022

Completion date

Jan 31, 2023

Anticipated

Primary completion date

Dec 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

145 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Proparacaine Hydrochloride ophthalmic solution, USP 0.5%

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

Balanced salt solution

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

Primary outcome measure

  • Association between reduction of pain/discomfort and anesthetic use [ Time Frame: 1 minute ]

Central Contacts and Locations

Central contacts

Locations

Louisiana State University Health Sciences Center

Recruiting

New Orleans, Louisiana, United States, 70112

More Information

Sponsor

Louisiana State University Health Sciences Center in New Orleans

Last update posted

Dec 23, 2022

Last verified

Dec, 2022

Keywords

  • Nasolacrimal duct obstruction
  • Probe and irrigation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Louisiana State University Health Sciences Center in New Orleans on 2022-12-23.