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Corneal AbrasionPhase 3NCT02483897

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

A Phase 3 study testing Tetracaine 0.5% ophthalmic drops in people with Corneal Abrasion, run by Queen's University.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Corneal Abrasion
What is being tested?
Tetracaine 0.5% ophthalmic drops
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Jun 2015to Aug 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Patients with frankly contaminated wound, corneal foreign body, or epithelial defect secondary to contact lens wear
  • History of comorbid eye conditions including eye surgery within the past month and glaucoma.
  • Involvement of both eyes
  • Allergy to tetracaine or any of the substances used in the study
  • Unable to provide consent.
  • Unable to come for follow-up.
  • 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.

About this study

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.

Read the detailed description

Corneal abrasions are commonly encountered eye injuries presenting to acute care settings and account for over 10% of new ophthalmological presentations at eye accident departments, primary care offices, and emergency departments. Patients complain of severe eye pain, foreign body sensation, pain with blinking, and photophobia. Corneal abrasions are defects in the epithelial layer that occur secondary to mechanical ocular surface trauma. Common causes of corneal abrasions include fingernail injuries, tree branches, and projectile pieces of metal, wood, or glass that injure or become embedded in the cornea. . Though associated with significant discomfort, the prognosis for simple corneal abrasions is usually excellent, with full recovery within 24-48 hours. Untreated abrasions, particularly those associated with a retained foreign body, can lead to complications such as corneal ulcers, prolonged pain, and visual acuity loss.

Currently, the standard approach to treating corneal abrasions includes removal of the foreign body if present, oral analgesics for pain control, and topical antibiotics. Traditional guidelines by ophthalmologists have advocated against the use of topical anesthetics due to concerns with corneal epithelial healing the potential for patients to miss important clinical clues that indicate the rare development of secondary corneal infection, as well as the potential for longer term misuse leading to severe corneal ulceration and perforation. Previous studies, primarily using animal models, have found a delay in corneal epithelial healing with topical anaesthetics, particularly with repeated and prolonged usage. Several case studies have described impaired corneal epithelial healing and ulceration with the prolonged use and abuse of topical anesthetic drops (0.05% proparacaine HCl). There have been reports of topical anesthetic (TA) induced corneal damage including punctate epitheliopathy, corneal lysis, perforation, persistent epithelial defects, and ocular inflammation. It is thought that local anesthetics inhibit mitosis and cellular migration, preventing proper re-epithelialization of the cornea.

However, in recent years a number of randomized clinical trials and case studies of human subjects have shown that with appropriate application and restricted short term usage, topical anesthetics did not delay wound healing or increase risks of corneal ulceration.

A recent prospective, randomized, double-blind trial looked at the effect of topical anesthetics on epithelial healing and pain management for patients with uncomplicated corneal abrasion. The study included 116 patients presenting to the emergency department who were given either 1% tetracaine HCl or control artificial tears. The study found no change in corneal healing rate or persistent symptoms but little benefit in pain relief as measured at 48 hrs. A previous prospective randomized study comparing 0.05% proparacaine and placebo has shown a significant decrease in reported pain with topical anesthetic use compared to control with no change in corneal healing. Another study evaluating the effect of 1% tetracaine for pain management after photorefractive keratectomy also reported significant pain reduction with topical anesthetic use with no delays in epithelial healing.

Controversy continues to exist over the utility of topical anesthetics in managing pain and their safety in affecting corneal healing. Contemporary studies of short term topical anesthetic use, noted above, have not shown adverse effects on healing. Differential effects on pain management have been found. Yet the investigators believe the Waldman study measured pain at a delayed time when the abrasion would be expected to have healed. Clinicians in Queen's Department of Emergency Medicine do not generally prescribe topical anesthetics for corneal abrasions and believe that evidence demonstrating their efficacy and safety would change practice patterns for the benefit of patients with these injuries and those in other centres. The investigators also hope that this study will better address problems of inadequate participant enrollment and retention that previous studies have encountered.

1.3 - Research Question In adult emergency department patients with acute corneal abrasions, is the application of 0.5% tetracaine effective in the short-term management of pain while not being associated with adverse effects on healing?

1.4 - Hypothesis Based on the review of existing literature on the effects of topical anesthetics, the investigators hypothesize that short-term and controlled usage of tetracaine will be an effective way in managing patient pain and will not affect corneal healing.

Being tested
Tetracaine 0.5% ophthalmic drops, Normal Saline placebo drops
Medical subject headings
Corneal Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tetracaine 0.5% ophthalmic dropsDrug

    0.8 mls. drops provided to be used hourly p.r.n. for pain control

  • Normal Saline placebo dropsDrug

    0.8 mls. drops provided to be used hourly p.r.n. for pain control

Study groups in NCT02483897
Study groupRoleWhat they receive
Tetracaine 0.5% ophthalmic dropsExperimental0.8 mls. drops provided to be used hourly p.r.n. for pain control
Receives: Drug: Tetracaine 0.5% ophthalmic drops
placebo (Normal Saline placebo drops)Placebo comparator0.8 mls. drops provided to be used hourly p.r.n. for pain control
Receives: Drug: Normal Saline placebo drops

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pain control as measured by visual analogue score

    10 cm. VAS scale

    Measured: at 12 hours post baseline

Secondary outcomes (1)
  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

    adverse outcome measure

    Measured: at 36-48 hour follow up appointment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionAug 2015
  4. Study completionAug 2015

Why it stopped: inabililty to recruit at required rate

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02483897
Sponsor's protocol ID
6015429
Status last verified
Jun 2018
First submitted
18 Jun 2015
Last updated
4 Jun 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 35622535

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tetracaine 0.5% ophthalmic drops in people with Corneal Abrasion, run by Queen's University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 4 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pain control as measured by visual analogue score (time frame: at 12 hours post baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02483897, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2018.

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