Proparacaine vs Placebo for Corneal Injuries (Dogma)
Primary Purpose
Corneal Abrasions
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Proparacaine drops 0.05%
saline drops
Sponsored by
About this trial
This is an interventional treatment trial for Corneal Abrasions focused on measuring cornea, analgesia, topical, anesthetic
Eligibility Criteria
Inclusion Criteria:
- adult patients with acute (within 24 hrs) traumatic corneal injuries
Exclusion Criteria:
- immunocompromised
- known allergy to local anesthetic
- unable to consent /follow instructions for dosing / go to follow-up appointments
- previous ocular pathology
Sites / Locations
- London Health Sciences Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
patients randomized to 0.05% Proparacaine drops on a PRN basis for up to 7 days Acetaminophen with Codeine for breakthrough pain topical Gatifloxacin drops
placebo drops on a PRN basis for up to 7 days post injury Acetaminophen with Codeine for breakthrough pain Gatifloxacin drops
Outcomes
Primary Outcome Measures
pain reduction
Secondary Outcome Measures
patient satisfaction
delayed wound healing
Full Information
NCT ID
NCT00620997
First Posted
February 12, 2008
Last Updated
February 21, 2008
Sponsor
London Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT00620997
Brief Title
Proparacaine vs Placebo for Corneal Injuries
Acronym
Dogma
Official Title
Challenging the Dogma: Topical Proparacaine is Safe and Effective for the Emergency Department Management of Acute Traumatic Corneal Injuries
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
London Health Sciences Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Introduction: Traumatic injuries to the outer covering of the eye (the cornea) are a common emergency department complaint. They cause significant patient distress including pain, loss of sleep and missed work days. There is currently no accepted, uniform approach to pain management in this patient population. Emergency medicine and ophthalmology texts state that prolonged use of medications that anesthetize the cornea is not recommended. Several recent publications in the ophthalmology literature show that the outpatient use of dilute local anesthesia in patients after eye surgery is a safe and effective method of pain control. In this study, we used Proparacaine (a local anesthetic), in a similar manner, for the outpatient emergency department management of traumatic corneal injuries.
Methods: We performed a clinical trial on a sample of adult patients presenting with traumatic corneal injuries to two university affiliated emergency departments in London, Canada.
Patients providing signed informed consent to participate in the study received a vial of clear liquid that contained either Proparacaine or plain water (placebo), a pain log, topical antibiotics and oral Acetaminophen (Tylenol) with Codeine for breakthrough pain.
Patients were instructed to use the "study drug" on an "as-needed" basis for the next seven days. Patients completed a pain scale describing their discomfort immediately prior to, and five minutes after self-administration of the study drug. All patients were followed closely in an ophthalmology outpatient clinic on Days 1, 3 and 5 after presentation to the emergency department. At the last ophthalmology clinic visit, the patients' pain logs were collected.
The protocol was approved by the Research Ethics Board for Health Sciences Research Involving Human Subjects at the University of Western Ontario.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Abrasions
Keywords
cornea, analgesia, topical, anesthetic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
patients randomized to 0.05% Proparacaine drops on a PRN basis for up to 7 days
Acetaminophen with Codeine for breakthrough pain
topical Gatifloxacin drops
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo drops on a PRN basis for up to 7 days post injury
Acetaminophen with Codeine for breakthrough pain
Gatifloxacin drops
Intervention Type
Drug
Intervention Name(s)
Proparacaine drops 0.05%
Intervention Description
topical, 0.05% drops, PRN continuously for up to 7 days
Intervention Type
Drug
Intervention Name(s)
saline drops
Intervention Description
saline drops continuously PRN for up to 7 days
Primary Outcome Measure Information:
Title
pain reduction
Time Frame
continuous
Secondary Outcome Measure Information:
Title
patient satisfaction
Time Frame
at 5 days post injury
Title
delayed wound healing
Time Frame
days 3,5 ,7 postinjury
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients with acute (within 24 hrs) traumatic corneal injuries
Exclusion Criteria:
immunocompromised
known allergy to local anesthetic
unable to consent /follow instructions for dosing / go to follow-up appointments
previous ocular pathology
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott B Anderson, MD FRCPC
Organizational Affiliation
London Health Sciences Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Center
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
12. IPD Sharing Statement
Citations:
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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Proparacaine vs Placebo for Corneal Injuries
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