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

Phase 4
Waitlist Available
Led By Austin M Pharo, MD
Research Sponsored by Louisiana State University Health Sciences Center in New Orleans
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 minute
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

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.

Eligible Conditions
  • Blocked Tear Duct
  • Dacryocystitis
  • Dacryoadenitis
  • Watery Eyes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 minute
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 minute for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Association between reduction of pain/discomfort and anesthetic use

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Participants with obstruction of the lacrimal systemExperimental Treatment2 Interventions
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.
Group II: Participants with no obstruction of the lacrimal systemExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Balanced salt solution
2017
Completed Phase 4
~50

Find a Location

Who is running the clinical trial?

Louisiana State University Health Sciences Center in New OrleansLead Sponsor
120 Previous Clinical Trials
42,241 Total Patients Enrolled
Austin M Pharo, MDPrincipal InvestigatorLSU Health Sciences Center
~26 spots leftby Jan 2026