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Treatment of Corneal Abrasions With Topical Tetracaine

Primary Purpose

Corneal Abrasion

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ophthalmic Tetracaine
Normal Saline
Sponsored by
New York Presbyterian Brooklyn Methodist Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corneal Abrasion

Eligibility Criteria

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

Inclusion Criteria:

  • Patients > 18 years of age with a primary diagnosis of uncomplicated corneal abrasion presenting to NYMH emergency department

Exclusion Criteria:

  • Patients<18 years of age with complicated corneal abrasions or other eye injuries
  • Present more than 36 hours after their initial injury
  • Had previous eye surgery or cataracts
  • Wear contact lenses or if their injury was caused from contact lens wear
  • Had injured both eyes
  • Unable to give informed consent
  • Current infectious or chemical conjunctivitis
  • Have a grossly contaminated foreign body in their eye
  • Currently suffering from an ocular infection
  • Currently or previously had herpes keratitis
  • Allergies to tetracaine or similar medication classes
  • Had an injury requiring urgent ophthalmologic evaluation; including penetrating eye injuries, large or complicated corneal abrasions, or injuries causing a significant disruption of visio)
  • Unable to attend follow up in 48 hours

Sites / Locations

  • New York Methodist Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tetracaine Group

Normal Saline Group

Arm Description

Patients with he primary diagnosis of corneal abrasion will be treated with ophthalmic tetracaine. Tetracaine will be supplied in three plastic prefilled, commercially available vials, each containing 0.5 mL of preservative-free, undiluted 1% tetracaine hydrochloride (a total of 1.5 mL or approximately 50 drops will be provide to avoid overuse). Patients will be instructed to use 1-2 drops of up to every 30 min for pain control over a 48 hour period with subsequent followup with the ophthalmologist.

Patients with the primary diagnosis of corneal abrasion will be treated with normal saline eye drops. Normal saline will be supplied in three plastic prefilled, commercially available vials, each containing 0.5 mL of normal saline. Patients will be instructed to use 1-2 drops of up to every 30 min for pain control over a 48 hour period with subsequent followup with the ophthalmologist.

Outcomes

Primary Outcome Measures

Pain assessed with Visual Analog Scale
Participants receiving both arms of the study (Tetracaine and Normal Saline) will be provided with a Visual Analog Scale in there study welcome packet. Scales will be completed at the end of 48 hours and submitted at follow up visit or mailed in if visit is deferred.

Secondary Outcome Measures

Full Information

First Posted
May 2, 2016
Last Updated
May 10, 2016
Sponsor
New York Presbyterian Brooklyn Methodist Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02771392
Brief Title
Treatment of Corneal Abrasions With Topical Tetracaine
Official Title
Treatment of Corneal Abrasions With Topical Tetracaine: an Evaluation of Safety and Efficacy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York Presbyterian Brooklyn Methodist Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Corneal abrasion (CA) is one of the most common eye injuries, accounting for 10% of eye-related emergency visits.1 A 1985 survey showed that around 3% of all visits to US general practitioners were for corneal abrasions. In addition, in 2008, approximately 27,450 work-related eye injuries and illnesses occurred that caused missed time from work.1Due to the large number of nerve endings even small corneal injuries can produce significant pain. The discomfort is typically most pronounced in the first 24-48 hours, and in many cases showed a loss in time at work and disruption of daily activities. The current standard of care in the emergency department includes topical analgesia and antibiotics with a change to oral analgesics upon discharge. Despite the ineffectiveness of oral analgesics in treating CA pain, most physicians do not prescribe topical analgesics based on standard medical teaching. The study's aim is to further investigate the role of tetracaine in the outpatient management of CA utilizing models already established to ensure safety. To accomplish this investigators will employ a prospective, double blind, randomized control model to compare undiluted 1% tetracaine hydrochloride to normal saline in patients presenting to the ED with uncomplicated corneal abrasions. Tetracaine will be supplied in three plastic prefilled, commercially available vials, each containing 0.5 mL of preservative-free, undiluted 1% tetracaine hydrochloride (a total of 1.5 mL or approximately 50 drops will be provide to avoid overuse). Saline will also be supplied in three plastic prefilled, commercially available vials, plastic bullets. Follow up visits or calls will be provide at 48 hour to reevaluate symptoms an asses the patients perceived pain using VAS provided in participant introduction packet during the informed consent process.
Detailed Description
Corneal abrasion (CA) is one of the most common eye injuries, accounting for 10% of eye-related emergency visits.1 A 1985 survey showed that around 3% of all visits to US general practitioners were for corneal abrasions. In addition, in 2008, approximately 27,450 work-related eye injuries and illnesses occurred that caused missed time from work.1Due to the large number of nerve endings even small corneal injuries can produce significant pain. The discomfort is typically most pronounced in the first 24-48 hours, and in many cases showed a loss in time at work and disruption of daily activities. The current standard of care in the emergency department includes topical analgesia and antibiotics with a change to oral analgesics upon discharge. Despite the ineffectiveness of oral analgesics in treating CA pain, most physicians do not prescribe topical analgesics based on standard medical teaching. This teaching is extrapolated from data from case reports and animal studies reporting complications associated with long-term use; including addiction, infection, ulceration, and increased healing time. Previous studies have also rejected topical analgesia citing equivocal effectiveness and inconclusive safety data. However, all of the early human case reports described patients who used topical anesthetics inappropriately-either far too frequently, for too prolonged a treatment period, or with too concentrated an anesthetic. Contrary to the medical cannon, studies have now begun show the effectiveness of topical anesthetics in reducing pain, and safe application when given at low doses and when given in quantities lasting only 24-48 hours. A recent prospective, randomized trial, published in Academic Emergency Medicine, observed the efficacy and safety of tetracaine compared to normal saline in 116 patients presenting with uncomplicated CA. The intervention was either undiluted topical tetracaine hydrochloride 1% or saline, applied up to every 30 minutes for 24 hours. The study showed topical tetracaine used for 24 hours was safe, revealing no difference in complications between the two groups, with all individuals attaining full healing within 1 month. Additionally, median visual analog scale (VAS) pain scores were lower in the tetracaine group at all study time points after presentation, however statistical significance was not observed. Furthermore, patient surveys on overall effectiveness revealed that patients perceived tetracaine to be significantly more effective than saline. In fact, several researchers now recommend that the short-term use of tetracaine eye drops for 24 hours for pain relief from simple corneal abrasions should become routine practice. Nevertheless both skeptics and supporters agree that more research is needed in order to appropriately establish topical analgesics as a the standard of care. The importance of conducting research in the management of CA is underscored by the significant impact topical analgesics may provide in reliving patients pain compared to standard treatment. The study's aim is to further investigate the role of tetracaine in the outpatient management of CA utilizing models already established to ensure safety. This study will employ a prospective, double blind, randomized control model to compare undiluted 1% tetracaine hydrochloride to normal saline in patients presenting to the ED with uncomplicated corneal abrasions. Tetracaine will be supplied in three plastic prefilled, commercially available vials, each containing 0.5 mL of preservative-free, undiluted 1% tetracaine hydrochloride (a total of 1.5 mL or approximately 50 drops will be provide to avoid overuse). Saline will also be supplied in three plastic prefilled, commercially available vials, plastic bullets. Follow up visits or calls will be provide at 48 hour to reevaluate symptoms an asses the patients perceived pain using VAS provided in participant introduction packet during the informed consent process. STUDY PROCEDURES a. Study visits and parameters to be measured Patients will be assessed using a VAS upon follow up at 48 hours. Patients will also be evaluated for complications either by phone or at a follow-up visit, which is at the participants discretion. All patients will be encouraged to follow up with ophthalmology as-per standard protocol. c. Drugs to be used (dose, method, schedule of administration, dose modifications, toxicities), include Toxicity Grading Scale (if applicable) Tetracaine will be supplied in three plastic prefilled, commercially available vials, each containing 0.5 mL of preservative-free, undiluted 1% tetracaine hydrochloride (a total of 1.5 mL or approximately 50 drops will be provide to avoid overuse). Patient will be instructed to use no more than 1-2 drops in the affected eye every 30 minutes while awake for 24-48 hours STATISTICAL ANALYSIS List of variables and their definition Variables will include perceived pain using a VAS, and overall perceived effectiveness of solution provided. Outcome measures,endpoints The outcome of interest is weather-or-not tetracaine is superior to placebo in controlling pain caused by CA Type of analysis A two sample T-test will be used comparing the average pain scale between the tetracaine and placebo group Sample size of 100-200 patients is expected

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Abrasion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tetracaine Group
Arm Type
Experimental
Arm Description
Patients with he primary diagnosis of corneal abrasion will be treated with ophthalmic tetracaine. Tetracaine will be supplied in three plastic prefilled, commercially available vials, each containing 0.5 mL of preservative-free, undiluted 1% tetracaine hydrochloride (a total of 1.5 mL or approximately 50 drops will be provide to avoid overuse). Patients will be instructed to use 1-2 drops of up to every 30 min for pain control over a 48 hour period with subsequent followup with the ophthalmologist.
Arm Title
Normal Saline Group
Arm Type
Placebo Comparator
Arm Description
Patients with the primary diagnosis of corneal abrasion will be treated with normal saline eye drops. Normal saline will be supplied in three plastic prefilled, commercially available vials, each containing 0.5 mL of normal saline. Patients will be instructed to use 1-2 drops of up to every 30 min for pain control over a 48 hour period with subsequent followup with the ophthalmologist.
Intervention Type
Drug
Intervention Name(s)
Ophthalmic Tetracaine
Other Intervention Name(s)
1% tetracaine solution
Intervention Description
1-2 drops to affected eye every 15-30 minutes over 24-48 hours as need
Intervention Type
Other
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
sodium chloride in 0.85% solution
Intervention Description
1-2 drops to affected eye every 15-30 minutes over 24-48 hours as need
Primary Outcome Measure Information:
Title
Pain assessed with Visual Analog Scale
Description
Participants receiving both arms of the study (Tetracaine and Normal Saline) will be provided with a Visual Analog Scale in there study welcome packet. Scales will be completed at the end of 48 hours and submitted at follow up visit or mailed in if visit is deferred.
Time Frame
Up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients > 18 years of age with a primary diagnosis of uncomplicated corneal abrasion presenting to NYMH emergency department Exclusion Criteria: Patients<18 years of age with complicated corneal abrasions or other eye injuries Present more than 36 hours after their initial injury Had previous eye surgery or cataracts Wear contact lenses or if their injury was caused from contact lens wear Had injured both eyes Unable to give informed consent Current infectious or chemical conjunctivitis Have a grossly contaminated foreign body in their eye Currently suffering from an ocular infection Currently or previously had herpes keratitis Allergies to tetracaine or similar medication classes Had an injury requiring urgent ophthalmologic evaluation; including penetrating eye injuries, large or complicated corneal abrasions, or injuries causing a significant disruption of visio) Unable to attend follow up in 48 hours
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charles A Pereyra, M.D.
Phone
516 587-4520
Email
cap9126@nyp.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Melville, M.D.
Organizational Affiliation
New York Presbyterian Brooklyn Methodist Hospital
Official's Role
Study Director
Facility Information:
Facility Name
New York Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Melville, M.D.
Phone
718-780-5040
Email
lmelville@me.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Plan to share data of pain perception and complications of patients
Citations:
PubMed Identifier
24730399
Citation
Waldman N, Densie IK, Herbison P. Topical tetracaine used for 24 hours is safe and rated highly effective by patients for the treatment of pain caused by corneal abrasions: a double-blind, randomized clinical trial. Acad Emerg Med. 2014 Apr;21(4):374-82. doi: 10.1111/acem.12346.
Results Reference
background
PubMed Identifier
25269590
Citation
Pruet CM, Feldman RM, Kim G. Re: "topical tetracaine used for 24 hours is safe and rated highly effective by patients for the treatment of pain caused by corneal abrasions: a double-blind, randomized clinical trial". Acad Emerg Med. 2014 Sep;21(9):1062-3. doi: 10.1111/acem.12470. No abstract available.
Results Reference
background
PubMed Identifier
26281814
Citation
Swaminathan A, Otterness K, Milne K, Rezaie S. The Safety of Topical Anesthetics in the Treatment of Corneal Abrasions: A Review. J Emerg Med. 2015 Nov;49(5):810-5. doi: 10.1016/j.jemermed.2015.06.069. Epub 2015 Aug 15.
Results Reference
background
PubMed Identifier
24672709
Citation
Segal KL, Fleischut PM, Kim C, Levine B, Faggiani SL, Banerjee S, Gadalla F, Lelli GJ Jr. Evaluation and treatment of perioperative corneal abrasions. J Ophthalmol. 2014;2014:901901. doi: 10.1155/2014/901901. Epub 2014 Feb 4.
Results Reference
result
PubMed Identifier
35622535
Citation
Algarni AM, Guyatt GH, Turner A, Alamri S. Antibiotic prophylaxis for corneal abrasion. Cochrane Database Syst Rev. 2022 May 27;5(5):CD014617. doi: 10.1002/14651858.CD014617.pub2.
Results Reference
derived

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Treatment of Corneal Abrasions With Topical Tetracaine

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