Treatment of Corneal Abrasions With Topical Tetracaine

NCT02771392 | Unknown Phase 2

• 1 other identifier: CA001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Corneal Abrasion

Outcome Measures

Primary Outcomes (1)

• Pain assessed with Visual Analog Scale

  Participants receiving both arms of the study (Tetracaine and Normal Saline) will be provided with a Visual Analog Scale in there study welcome packet. Scales will be completed at the end of 48 hours and submitted at follow up visit or mailed in if visit is deferred.

  Up to 24 months

Study Arms (2)

Tetracaine Group

EXPERIMENTAL

Patients with he primary diagnosis of corneal abrasion will be treated with ophthalmic tetracaine. 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). Patients will be instructed to use 1-2 drops of up to every 30 min for pain control over a 48 hour period with subsequent followup with the ophthalmologist.

Drug: Ophthalmic Tetracaine

Normal Saline Group

PLACEBO COMPARATOR

Patients with the primary diagnosis of corneal abrasion will be treated with normal saline eye drops. Normal saline will be supplied in three plastic prefilled, commercially available vials, each containing 0.5 mL of normal saline. Patients will be instructed to use 1-2 drops of up to every 30 min for pain control over a 48 hour period with subsequent followup with the ophthalmologist.

Other: Normal Saline

Interventions

Ophthalmic Tetracaine DRUG

1-2 drops to affected eye every 15-30 minutes over 24-48 hours as need

Also known as: 1% tetracaine solution

Tetracaine Group

Normal Saline OTHER

1-2 drops to affected eye every 15-30 minutes over 24-48 hours as need

Also known as: sodium chloride in 0.85% solution

Normal Saline Group

Eligibility Criteria

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

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

Sponsors & Collaborators

• New York Presbyterian Brooklyn Methodist Hospital: lead

Study Sites (1)

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Related Publications (5)

• Waldman N, Densie IK, Herbison P. Topical tetracaine used for 24 hours is safe and rated highly effective by patients for the treatment of pain caused by corneal abrasions: a double-blind, randomized clinical trial. Acad Emerg Med. 2014 Apr;21(4):374-82. doi: 10.1111/acem.12346.

  PMID: 24730399 BACKGROUND

• Pruet CM, Feldman RM, Kim G. Re: "topical tetracaine used for 24 hours is safe and rated highly effective by patients for the treatment of pain caused by corneal abrasions: a double-blind, randomized clinical trial". Acad Emerg Med. 2014 Sep;21(9):1062-3. doi: 10.1111/acem.12470. No abstract available.

  PMID: 25269590 BACKGROUND

• Swaminathan A, Otterness K, Milne K, Rezaie S. The Safety of Topical Anesthetics in the Treatment of Corneal Abrasions: A Review. J Emerg Med. 2015 Nov;49(5):810-5. doi: 10.1016/j.jemermed.2015.06.069. Epub 2015 Aug 15.

  PMID: 26281814 BACKGROUND

• Segal KL, Fleischut PM, Kim C, Levine B, Faggiani SL, Banerjee S, Gadalla F, Lelli GJ Jr. Evaluation and treatment of perioperative corneal abrasions. J Ophthalmol. 2014;2014:901901. doi: 10.1155/2014/901901. Epub 2014 Feb 4.

  PMID: 24672709 RESULT

• 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

Saline Solution; Sodium Chloride; 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)

Crystalloid Solutions; Isotonic Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Laura Melville, M.D.

  New York Presbyterian Brooklyn Methodist Hospital

  STUDY DIRECTOR

Central Study Contacts

Charles A Pereyra, M.D.

CONTACT

516 587-4520; cap9126@nyp.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: May 13, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: October 1, 2018
• Last Updated: May 13, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)