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Effect of Tetracaine on Pain Management and Corneal Healing in Patients With Acute Corneal Abrasion

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ClinicalTrials.gov Identifier: NCT02483897
Recruitment Status : Withdrawn (inabililty to recruit at required rate)
First Posted : June 29, 2015
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Robert Brison, Queen's University

Brief Summary:

Corneal abrasions are associated with significant discomfort during a 24-48 hrs healing phase. Current practice guidelines discourage the use of topical anesthetics in treating these patients due to concerns that these medications may prevent proper corneal epithelial healing. These concerns are based primarily on decades old animal based research. However, recent evidence suggests topical anaesthetics are a safe and effective way of managing patient pain in the short term. This study will investigate the effect of topical 0.5% tetracaine on corneal healing and pain management in patients with corneal abrasions in the first 48 hours.

This will be a prospective, double blind, randomized, controlled study of 260 adults with uncomplicated acute corneal injuries presenting to the tertiary acute care settings in Kingston. Patients will be randomly assigned to receive either 0.5% tetracaine or saline in addition to usual care as outpatients. They will be followed through the ophthalmology emergency eye clinic to assess healing at 36-48hrs. after the acute care visit. The primary outcome will be an assessment of pain as measured every 4 hours for 48 hrs. using a 10mm Visual Analogue Scale (VAS). Secondary outcomes will include assessments of corneal healing, use of adjunct pain medications, time lost from work/usual activities, quality of sleep, ability to read and the SF12 quality of life questionnaire.

This study will better inform the safety and effectiveness of short-term tetracaine usage in patients with simple corneal abrasions for optimal treatment of patients in the future.


Condition or disease Intervention/treatment Phase
Corneal Abrasion Drug: Tetracaine 0.5% ophthalmic drops Drug: Normal Saline placebo drops Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Tetracaine on Pain Management and Corneal Healing in Patients With Acute Corneal Abrasion
Study Start Date : June 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tetracaine 0.5% ophthalmic drops
0.8 mls. drops provided to be used hourly p.r.n. for pain control
Drug: Tetracaine 0.5% ophthalmic drops
0.8 mls. drops provided to be used hourly p.r.n. for pain control

Placebo Comparator: placebo (Normal Saline placebo drops)
0.8 mls. drops provided to be used hourly p.r.n. for pain control
Drug: Normal Saline placebo drops
0.8 mls. drops provided to be used hourly p.r.n. for pain control




Primary Outcome Measures :
  1. pain control as measured by visual analogue score [ Time Frame: at 12 hours post baseline ]
    10 cm. VAS scale


Secondary Outcome Measures :
  1. Compound Outcome comprised of Number of Participants with one or more of listed adverse outcomes including: anaphylactic reaction, infectious infiltrate, stromal/ring infiltrate, corneal ulceration, hypopyon, abrasion size not decreasing [ Time Frame: at 36-48 hour follow up appointment ]
    adverse outcome measure



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients (>18yo) coming in with acute (<24 hours) simple uncomplicated corneal abrasions.

Exclusion Criteria:

  1. Patients with frankly contaminated wound, corneal foreign body, or epithelial defect secondary to contact lens wear
  2. History of comorbid eye conditions including eye surgery within the past month and glaucoma.
  3. Involvement of both eyes
  4. Allergy to tetracaine or any of the substances used in the study
  5. Unable to provide consent.
  6. Unable to come for follow-up.
  7. Patients with a past history of corneal injury infection or surgery will undergo a screening test of the corneal sensation. If a diminished or absent sensation is found, the patient will be excluded from the study.

Responsible Party: Dr. Robert Brison, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT02483897     History of Changes
Other Study ID Numbers: 6015429
First Posted: June 29, 2015    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Tetracaine
Ophthalmic Solutions
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Pharmaceutical Solutions