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RECRUITING Phase 4

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

NCT05663684 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 145 participants
Start Date 2020-06-30
Est. Completion 2023-01-31
Phase Phase 4

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05663684

The ClinicalTrials.gov registry entry for NCT05663684 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 145 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Louisiana State University Health Sciences Center in New Orleans, which has 13 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05663684 reports 1 study location spanning 1 distinct geographic area — top geographies include Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05663684?

This trial is sponsored by Louisiana State University Health Sciences Center in New Orleans, which has 13 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial