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Does Topical Ophthalmic Anesthetic Prior to Probing and Irrigation Decrease Pain?

Primary Purpose

Epiphora, Dacryostenosis, Dacryocystitis

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Proparacaine Hydrochloride ophthalmic solution, USP 0.5%
Balanced salt solution
Sponsored by
William Beaumont Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epiphora focused on measuring Nasolacrimal duct obstruction, Probe and irrigation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Beaumont Royal Oak or any of the listed physician offices who present with a chief 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

Sites / Locations

  • Dianne Schlachter

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Participants who received proparacaine hydrochloride solution in left eye and placebo in right eye

Participants who received proparacaine hydrochloride solution in right eye and placebo in left eye

Arm Description

Participants receiving a drop of Proparacaine Hydrocholoride 0.5% ophthalmic solution in left eye and a drop of basic salt solution (BSS, placebo) in the right eye prior to probing and irrigation.

Participants receiving a drop of Proparacaine Hydrocholoride 0.5% ophthalmic solution in right eye and a drop of basic salt solution (BSS, placebo) in the left prior to probing and irrigation.

Outcomes

Primary Outcome Measures

Count of Participants Who Report of Less Discomfort in the Eye That Received the Proparacaine Hydrochloride Anesthetic During Probing
Participants completed a survey which asked which procedure was more uncomfortable (left or right). Assignment to receive proparacaine hydrochloride was compared to survey results. When the participant reported less discomfort in the eye that received the proparacaine hydrochloride medication, this is is reported as concordance between reduction of pain/discomfort and anesthetic use.

Secondary Outcome Measures

Full Information

First Posted
January 9, 2020
Last Updated
December 21, 2022
Sponsor
William Beaumont Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT04229771
Brief Title
Does Topical Ophthalmic Anesthetic Prior to Probing and Irrigation Decrease Pain?
Official Title
Does Administration of Proparacaine Hydrochloride 0.5% Ophthalmic Solution Prior to Canalicular Probing and Irrigation Decrease Patient Discomfort
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
slow enrollment
Study Start Date
June 30, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
William Beaumont Hospitals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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 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.
Detailed Description
Rationale: It is common for male and female adults of all races with a chief complaint of epiphora (excessive tearing) to express discomfort either verbally or through body language while undergoing tear duct (canalicular) probing and irrigation even when no pathology is detected. Use of a topical anesthetic during canalicular probing and irrigation is seen in children but has yet to be formally investigated in adults to date. The goal of this study is to identify whether or not instillation of a drop of Proparacaine hydrochloride 0.5% ophthalmic solution into a participant's eye prior to performance of probing and irrigation will improve participant comfort during the procedure and is therefore recommended. Hypothesis: Administration of a drop of Proparacaine hydrochloride 0.5% ophthalmic solution into the eye prior to probing and irrigation of the lower lid canalicular system will decrease discomfort as compared to a control drop of BSS ophthalmic solution into the opposite eye prior to the same procedure. Null hypothesis: Administration of a drop of Proparacaine hydrochloride 0.5% ophthalmic solution does not have an effect on discomfort during canalicular probing and irrigation. Medication: Proparacaine hydrochloride ophthalmic solution, United States Pharmacopeia (USP) 0.5% is a local anesthetic drug intended for topical ophthalmic use. Proparacaine Hydrochloride ophthalmic solution is a fast-acting anesthetic lasting 10-20 minutes. Proparacaine hydrochloride ophthalmic solution, USP 0.5% is FDA approved for this indication. Probing and irrigation: A common in-office ophthalmic procedure performed with a small gauge, blunt tube on a syringe filled with BSS. The cannula is placed into the canaliculus (tear duct) of one eyelid, and the BSS is used to irrigate the lacrimal system. This procedure identifies whether or not obstruction of the lacrimal system is present. A participant with an open (patent) system will taste the salty BSS solution in the nose. A participant with a nasolacrimal duct obstruction (NLDO) or a more proximal canalicular obstruction will have reflux of the irrigant out of the opposite lid (on the same side) canaliculus, the probed canaliculus, or both and will usually not detect any irrigant within the nasopharynx. Definitions: Nasolacrimal drainage system: The physiologic apparatus which drains tears from the surface of the eye into the nose (i.e. the tear drain). It consists of (from eye to nose) the punctum (opening of the tube), the canaliculus (a thin tube within the eyelid), the lacrimal sac (a sac that hold the tears that lies within the bone of the nose) and finally the nasolacrimal duct (a duct that connects the lacrimal sac (-lacrimal) into the nose (naso-). A blockage anywhere along this pathway can cause epiphora. Epiphora: The pathological process of tears overflowing from the ocular surface and rolling down the face. Commonly caused by obstructions of the lacrimal drainage system. Can cause significant irritation and loss of vision.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiphora, Dacryostenosis, Dacryocystitis
Keywords
Nasolacrimal duct obstruction, Probe and irrigation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
A double-blinded, randomized, controlled clinical trial with one eye of each participant receiving the experimental treatment and one eye acting as control, receiving placebo
Masking
ParticipantCare Provider
Masking Description
Randomization will be performed by the primary investigator who will have no participant interaction during the performance of the procedure and obtainment of the survey responses. A random number generator will be used to obtain either an even or odd number. Odd numbers mean the left eye receives Proparacaine hydrochloride 0.5% ophthalmic solution, even numbers mean the right eye does. The chief investigator will instruct clinic personnel as to which syringe should be labeled "L" or "R" depending on randomization results.Two identical 1 ml syringes will be prepared. One syringe containing control BSS, and the other containing Proparacaine hydrochloride 0.5% ophthalmic solution. Each syringe will be labeled by clinical assistants with either left (L) or right (R) as randomized.
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Participants who received proparacaine hydrochloride solution in left eye and placebo in right eye
Arm Type
Experimental
Arm Description
Participants receiving a drop of Proparacaine Hydrocholoride 0.5% ophthalmic solution in left eye and a drop of basic salt solution (BSS, placebo) in the right eye prior to probing and irrigation.
Arm Title
Participants who received proparacaine hydrochloride solution in right eye and placebo in left eye
Arm Type
Experimental
Arm Description
Participants receiving a drop of Proparacaine Hydrocholoride 0.5% ophthalmic solution in right eye and a drop of basic salt solution (BSS, placebo) in the left prior to probing and irrigation.
Intervention Type
Drug
Intervention Name(s)
Proparacaine Hydrochloride ophthalmic solution, USP 0.5%
Other Intervention Name(s)
Alcaine
Intervention Description
One drop instilled in one eye, randomly chosen, as topical anesthetic
Intervention Type
Drug
Intervention Name(s)
Balanced salt solution
Other Intervention Name(s)
BSS
Intervention Description
One drop instilled in one eye, randomly chosen, as control placebo
Primary Outcome Measure Information:
Title
Count of Participants Who Report of Less Discomfort in the Eye That Received the Proparacaine Hydrochloride Anesthetic During Probing
Description
Participants completed a survey which asked which procedure was more uncomfortable (left or right). Assignment to receive proparacaine hydrochloride was compared to survey results. When the participant reported less discomfort in the eye that received the proparacaine hydrochloride medication, this is is reported as concordance between reduction of pain/discomfort and anesthetic use.
Time Frame
1 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Beaumont Royal Oak or any of the listed physician offices who present with a chief 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dianne M Schlachter, MD
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dianne Schlachter
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data to be shared

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Does Topical Ophthalmic Anesthetic Prior to Probing and Irrigation Decrease Pain?

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