NCT04187417

Brief Summary

The objective of this study was to show that patients with corneal abrasions would experience more pain relief with short term topical tetracaine than placebo, have similar complication rates, and take less hydrocodone for breakthrough pain.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 5, 2019

Completed
Last Updated

December 6, 2019

Status Verified

December 1, 2019

Enrollment Period

2.7 years

First QC Date

November 27, 2019

Last Update Submit

December 4, 2019

Conditions

Corneal Abrasion

Outcome Measures

Primary Outcomes (1)

  • Overall Visual Analog Scale score

    The primary endpoint of the study was the overall post study drop Visual Analog Scale pain score measured at the patients initial follow up Emergency Department visit. Measured on a 0-10 scale with 0 meaning no pain and 10 worst pain.

    48 hours

Secondary Outcomes (3)

  • Visual Analog Scale score

    1 week

  • Number of hydrocodone tablets taken

    48 hours

  • adverse events

    1 week

Study Arms (2)

Topical tetracaine

EXPERIMENTAL

Topical tetracaine hydrochoride 1%

Drug: topical tetracaine hydrochloride 1%

Balanced artificial tear solution

PLACEBO COMPARATOR

Balanced artificial tear solution (Systane)

Drug: Placebo

Interventions

topical tetracaine hydrochloride 1%DRUG

topical ophthalmologic anesthestic

Topical tetracaine
PlaceboDRUG

Placebo

Balanced artificial tear solution

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients aged 18 years to 80 years old presenting to the ED with suspected acute corneal abrasion from mechanical trauma or removal of a foreign body by the physician were included

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (16)

  • Waldman N, Winrow B, Densie I, Gray A, McMaster S, Giddings G, Meanley J. An Observational Study to Determine Whether Routinely Sending Patients Home With a 24-Hour Supply of Topical Tetracaine From the Emergency Department for Simple Corneal Abrasion Pain Is Potentially Safe. Ann Emerg Med. 2018 Jun;71(6):767-778. doi: 10.1016/j.annemergmed.2017.02.016. Epub 2017 May 5.

    PMID: 28483289BACKGROUND

  • 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: 24730399BACKGROUND

  • Ball IM, Seabrook J, Desai N, Allen L, Anderson S. Dilute proparacaine for the management of acute corneal injuries in the emergency department. CJEM. 2010 Sep;12(5):389-96. doi: 10.1017/s1481803500012537.

    PMID: 20880433BACKGROUND

  • Ting JY, Barns KJ, Holmes JL. Management of Ocular Trauma in Emergency (MOTE) Trial: A pilot randomized double-blinded trial comparing topical amethocaine with saline in the outpatient management of corneal trauma. J Emerg Trauma Shock. 2009 Jan;2(1):10-4. doi: 10.4103/0974-2700.44676.

    PMID: 19561949BACKGROUND

  • Verma S, Corbett MC, Patmore A, Heacock G, Marshall J. A comparative study of the duration and efficacy of tetracaine 1% and bupivacaine 0.75% in controlling pain following photorefractive keratectomy (PRK). Eur J Ophthalmol. 1997 Oct-Dec;7(4):327-33. doi: 10.1177/112067219700700404.

    PMID: 9457454BACKGROUND

  • Verma S, Corbett MC, Marshall J. A prospective, randomized, double-masked trial to evaluate the role of topical anesthetics in controlling pain after photorefractive keratectomy. Ophthalmology. 1995 Dec;102(12):1918-24. doi: 10.1016/s0161-6420(95)30775-0.

    PMID: 9098296BACKGROUND

  • Chang YS, Tseng SY, Tseng SH, Wu CL. Cytotoxicity of lidocaine or bupivacaine on corneal endothelial cells in a rabbit model. Cornea. 2006 Jun;25(5):590-6. doi: 10.1097/01.ico.0000220775.93852.02.

    PMID: 16783149BACKGROUND

  • Grant RL, Acosta D. Comparative toxicity of tetracaine, proparacaine and cocaine evaluated with primary cultures of rabbit corneal epithelial cells. Exp Eye Res. 1994 Apr;58(4):469-78. doi: 10.1006/exer.1994.1040.

    PMID: 7925683BACKGROUND

  • Bisla K, Tanelian DL. Concentration-dependent effects of lidocaine on corneal epithelial wound healing. Invest Ophthalmol Vis Sci. 1992 Oct;33(11):3029-33.

    PMID: 1399407BACKGROUND

  • Higbee RG, Hazlett LD. Topical ocular anesthetics affect epithelial cytoskeletal proteins of wounded cornea. J Ocul Pharmacol. 1989 Fall;5(3):241-53. doi: 10.1089/jop.1989.5.241.

    PMID: 2625618BACKGROUND

  • Rosenwasser GO, Holland S, Pflugfelder SC, Lugo M, Heidemann DG, Culbertson WW, Kattan H. Topical anesthetic abuse. Ophthalmology. 1990 Aug;97(8):967-72. doi: 10.1016/s0161-6420(90)32458-2.

    PMID: 2402423BACKGROUND

  • Rosenwasser GO. Complications of topical ocular anesthetics. Int Ophthalmol Clin. 1989 Fall;29(3):153-8. doi: 10.1097/00004397-198902930-00005. No abstract available.

    PMID: 2666331BACKGROUND

  • Henkes HE, Waubke TN. Keratitis from abuse of corneal anaesthetics. Br J Ophthalmol. 1978 Jan;62(1):62-5. doi: 10.1136/bjo.62.1.62.

    PMID: 629912BACKGROUND

  • Willis WE, Laibson PR. Corneal complications of topical anesthetic abuse. Can J Ophthalmol. 1970 Jul;5(3):239-43. No abstract available.

    PMID: 5472832BACKGROUND

  • Ahmed F, House RJ, Feldman BH. Corneal Abrasions and Corneal Foreign Bodies. Prim Care. 2015 Sep;42(3):363-75. doi: 10.1016/j.pop.2015.05.004. Epub 2015 Jul 31.

    PMID: 26319343BACKGROUND

  • Shipman S, Painter K, Keuchel M, Bogie C. Short-Term Topical Tetracaine Is Highly Efficacious for the Treatment of Pain Caused by Corneal Abrasions: A Double-Blind, Randomized Clinical Trial. Ann Emerg Med. 2021 Mar;77(3):338-344. doi: 10.1016/j.annemergmed.2020.08.036. Epub 2020 Oct 27.

    PMID: 33121832DERIVED

MeSH Terms

Conditions

Corneal Injuries

Condition Hierarchy (Ancestors)

Eye InjuriesFacial InjuriesCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesCorneal DiseasesEye DiseasesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
sealed, numbered opaque envelopes
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2019

First Posted

December 5, 2019

Study Start

January 1, 2015

Primary Completion

September 30, 2017

Study Completion

September 30, 2018

Last Updated

December 6, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share