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NCT05663684 · ClinicalTrials.gov registry record · Phase 4
Does Topical Ophthalmic Proparacaine 0.5% Prior to Probing and Irrigation Decrease Pain?
A Phase 4 study of Epiphora and Dacryostenosis, sponsored by Louisiana State University Health Sciences Center in New Orleans.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 145
- Enrollment target
- 1
- Study location
NCT05663684: Recruiting Phase 4 study of Epiphora and Dacryostenosis, sponsored by Louisiana State University Health Sciences Center in New Orleans.
NCT05663684 is a Phase 4 study of Epiphora and Dacryostenosis that is actively recruiting participants, run by Louisiana State University Health Sciences Center in New Orleans. The registered enrollment target is 145 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05663684, a Phase 4 study of Epiphora and Dacryostenosis, is actively recruiting participants, sponsored by Louisiana State University Health Sciences Center in New Orleans.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 145 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Count of participants who have concordance between instillation of anesthetic and report of less discomfort in that eye during probing
Conditions Studied
Interventions
- DRUG Proparacaine Hydrochloride ophthalmic solution, USP 0.5%
- DRUG Balanced salt solution
Study Locations (1)
Louisiana
- Louisiana State University Health Sciences Center - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2020-06-30 |
| Est. Completion | 2023-01-31 |
| Phase | Phase 4 |
What NCT05663684 shows while recruiting
NCT05663684 is an interventional study that assigns participants to a tested intervention. The registered 145 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (72% lower).
The record links to 3 conditions, with Epiphora appearing as the primary indexed condition, and to 2 interventions - of which Proparacaine Hydrochloride ophthalmic solution, USP 0.5% is the first listed.
NCT05663684 reports a single indexed study location in Louisiana.
Frequently Asked Questions
What is clinical trial NCT05663684 about?
NCT05663684 is a clinical study titled "Does Topical Ophthalmic Proparacaine 0.5% Prior to Probing and Irrigation Decrease Pain?". 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 form...
What is the current status of trial NCT05663684?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 145 participants. The study started on 2020-06-30. Estimated completion is 2023-01-31.
What conditions does trial NCT05663684 study?
This clinical trial studies the following conditions: Epiphora, Dacryostenosis, Dacryocystitis.
What interventions are being tested in trial NCT05663684?
The interventions under investigation include: Proparacaine Hydrochloride ophthalmic solution, USP 0.5% (DRUG), Balanced salt solution (DRUG).
Who is sponsoring clinical trial NCT05663684?
This trial is sponsored by Louisiana State University Health Sciences Center in New Orleans, which has 45 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05663684 being conducted?
This trial has 1 study location across Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05663684's enrollment target sits among peer trials
145 573rd of 2000 higher than 1,425 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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