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NCT04229771 · ClinicalTrials.gov registry record · Phase 4
Does Topical Ophthalmic Anesthetic Prior to Probing and Irrigation Decrease Pain?
A Phase 4 study, sponsored by Corewell Health East.
- Terminated
- Registry status
- Phase 4
- Development phase
- 2
- Enrollment target
NCT04229771 is a Phase 4 study that was terminated before completion, run by Corewell Health East. The registered enrollment target is 2 participants.
The verdict
NCT04229771, a Phase 4 study, was terminated before completion, sponsored by Corewell Health East.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 2 participants
- Enrollment target
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 William Beaumont Hospital - Royal Oak, Michigan outpatient ophthalmology clinic with a chief 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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2020-06-30 |
| Est. Completion | 2020-11-30 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04229771
The ClinicalTrials.gov registry entry for NCT04229771 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Corewell Health East, which has 106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Proparacaine Hydrochloride ophthalmic solution, USP 0.5% is the first listed.
NCT04229771 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04229771 about?
NCT04229771 is a clinical study titled "Does Topical Ophthalmic Anesthetic 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 NCT04229771?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 2 participants. The study started on 2020-06-30. Estimated completion is 2020-11-30.
What interventions are being tested in trial NCT04229771?
The interventions under investigation include: Proparacaine Hydrochloride ophthalmic solution, USP 0.5% (DRUG), Balanced salt solution (DRUG).
Who is sponsoring clinical trial NCT04229771?
This trial is sponsored by Corewell Health East, which has 106 total clinical trials registered on ClinicalTrials.gov.
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