Treatment of Corneal Abrasions With Topical Tetracaine

Status unconfirmed · Phase 2/Phase 3

Conditions studied: Corneal Abrasion

In brief

Corneal abrasion (CA) is one of the most common eye injuries, accounting for 10% of eye-related emergency visits.1 A 1985 survey showed that around 3% of all visits to US general practitioners were for corneal abrasions. In addition, in 2008, approximately 27,450 work-related eye injuries and illnesses occurred that caused missed time from work.1Due to the large number of nerve endings even small corneal injuries can produce significant pain. The discomfort is typically most pronounced in the first 24-48 hours, and in many cases showed a loss in time at work and disruption of daily activities. The current standard of care in the emergency department includes topical analgesia and antibiotics with a change to oral analgesics upon discharge. Despite the ineffectiveness of oral analgesics in treating CA pain, most physicians do not prescribe topical analgesics based on standard medical teaching. The study's aim is to further investigate the role of tetracaine in the outpatient management of CA utilizing models already established to ensure safety. To accomplish this investigators will employ a prospective, double blind, randomized control model to compare undiluted 1% tetracaine hydrochloride to normal saline in patients presenting to the ED with uncomplicated corneal abrasions. Tetracaine will be supplied in three plastic prefilled, commercially available vials, each containing 0.5 mL of preservative-free, undiluted 1% tetracaine hydrochloride (a total of 1.5 mL or approximately 50 drops will be provide to avoid overuse). Saline will also be supplied in three plastic prefilled, commercially available vials, plastic bullets. Follow up visits or calls will be provide at 48 hour to reevaluate symptoms an asses the patients perceived pain using VAS provided in participant introduction packet during the informed consent process.

Key facts

Study ID

NCT02771392

Run by

New York Presbyterian Brooklyn Methodist Hospital

People needed

120

Starts

2016-06-01

Expected to finish

2018-10-01

Last updated by the study team

2016-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients > 18 years of age with a primary diagnosis of uncomplicated corneal abrasion presenting to NYMH emergency department

You may not qualify if…

• Patients<18 years of age with complicated corneal abrasions or other eye injuries
• Present more than 36 hours after their initial injury
• Had previous eye surgery or cataracts
• Wear contact lenses or if their injury was caused from contact lens wear
• Had injured both eyes
• Unable to give informed consent
• Current infectious or chemical conjunctivitis
• Have a grossly contaminated foreign body in their eye
• Currently suffering from an ocular infection
• Currently or previously had herpes keratitis
• Allergies to tetracaine or similar medication classes
• Had an injury requiring urgent ophthalmologic evaluation; including penetrating eye injuries, large or complicated corneal abrasions, or injuries causing a significant disruption of visio)
• Unable to attend follow up in 48 hours

Where it is running

• New York Methodist Hospital — Brooklyn, New York, United States

Full record on ClinicalTrials.gov

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