Proparacaine vs Placebo for Corneal Injuries (Dogma)

This study has been completed.
Sponsor:
Information provided by:
London Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00620997
First received: February 12, 2008
Last updated: February 21, 2008
Last verified: September 2006
  Purpose

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.


Condition Intervention Phase
Corneal Abrasions
Drug: Proparacaine drops 0.05%
Drug: saline drops
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Challenging the Dogma: Topical Proparacaine is Safe and Effective for the Emergency Department Management of Acute Traumatic Corneal Injuries

Resource links provided by NLM:


Further study details as provided by London Health Sciences Centre:

Primary Outcome Measures:
  • pain reduction [ Time Frame: continuous ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • patient satisfaction [ Time Frame: at 5 days post injury ] [ Designated as safety issue: No ]
  • delayed wound healing [ Time Frame: days 3,5 ,7 postinjury ] [ Designated as safety issue: Yes ]

Enrollment: 43
Study Start Date: October 2005
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1

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

Drug: Proparacaine drops 0.05%
topical, 0.05% drops, PRN continuously for up to 7 days
Placebo Comparator: 2

placebo drops on a PRN basis for up to 7 days post injury

Acetaminophen with Codeine for breakthrough pain

Gatifloxacin drops

Drug: saline drops
saline drops continuously PRN for up to 7 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620997

Locations
Canada, Ontario
London Health Sciences Center
London, Ontario, Canada, N6A 5W9
Sponsors and Collaborators
London Health Sciences Centre
Investigators
Principal Investigator: Scott B Anderson, MD FRCPC London Health Sciences Center
  More Information

No publications provided

Responsible Party: Dr. Scott Anderson, London Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00620997     History of Changes
Other Study ID Numbers: London HSC
Study First Received: February 12, 2008
Last Updated: February 21, 2008
Health Authority: Canada: Ethics Review Committee

Keywords provided by London Health Sciences Centre:
cornea
analgesia
topical
anesthetic

Additional relevant MeSH terms:
Proxymetacaine
Propoxycaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014