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Proparacaine vs Placebo for Corneal Injuries (Dogma)

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ClinicalTrials.gov Identifier: NCT00620997
Recruitment Status : Completed
First Posted : February 22, 2008
Last Update Posted : February 22, 2008
Information provided by:
London Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
Corneal Abrasions Drug: Proparacaine drops 0.05% Drug: saline drops Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : October 2005
Primary Completion Date : September 2006
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. pain reduction [ Time Frame: continuous ]

Secondary Outcome Measures :
  1. patient satisfaction [ Time Frame: at 5 days post injury ]
  2. delayed wound healing [ Time Frame: days 3,5 ,7 postinjury ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00620997

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

Responsible Party: Dr. Scott Anderson, London Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00620997     History of Changes
Other Study ID Numbers: London HSC
First Posted: February 22, 2008    Key Record Dates
Last Update Posted: February 22, 2008
Last Verified: September 2006

Keywords provided by London Health Sciences Centre:

Additional relevant MeSH terms:
Corneal Injuries
Eye Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Corneal Diseases
Eye Diseases
Wounds and Injuries
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents