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
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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 |
Actual Primary Completion Date : | September 2006 |
Actual Study Completion Date : | September 2006 |

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 |
- pain reduction [ Time Frame: continuous ]
- patient satisfaction [ Time Frame: at 5 days post injury ]
- delayed wound healing [ Time Frame: days 3,5 ,7 postinjury ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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

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 |
Principal Investigator: | Scott B Anderson, MD FRCPC | London Health Sciences Center |
Responsible Party: | Dr. Scott Anderson, London Health Sciences Centre |
ClinicalTrials.gov Identifier: | NCT00620997 |
Other Study ID Numbers: |
London HSC |
First Posted: | February 22, 2008 Key Record Dates |
Last Update Posted: | February 22, 2008 |
Last Verified: | September 2006 |
cornea analgesia topical anesthetic |
Corneal Injuries Eye Injuries Facial Injuries Craniocerebral Trauma Trauma, Nervous System Nervous System Diseases Corneal Diseases Eye Diseases |
Wounds and Injuries Proxymetacaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |