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

NCT02483897 | Withdrawn Phase 3 DMC

• 1 other identifier: 6015429
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Corneal Abrasion

Outcome Measures

Primary Outcomes (1)

• pain control as measured by visual analogue score

  10 cm. VAS scale

  at 12 hours post baseline

Secondary Outcomes (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

  at 36-48 hour follow up appointment

Study Arms (2)

Tetracaine 0.5% ophthalmic drops

EXPERIMENTAL

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

Drug: Tetracaine 0.5% ophthalmic drops

placebo (Normal Saline placebo drops)

PLACEBO COMPARATOR

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

Drug: Normal Saline placebo drops

Interventions

Tetracaine 0.5% ophthalmic drops DRUG

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

Tetracaine 0.5% ophthalmic drops

Normal Saline placebo drops DRUG

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

placebo (Normal Saline placebo drops)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen's University: lead

Related Publications (1)

• 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.

  PMID: 35622535 DERIVED

MeSH Terms

Conditions

Corneal Injuries

Interventions

Tetracaine; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Eye Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Corneal Diseases; Eye Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 18, 2015
• First Posted: June 29, 2015
• Study Start: June 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: June 4, 2018

Record last verified: 2018-06