Bandage Contact Lens Application for the Management of Corneal Abrasion

Bandage Contact Lens Application for the Management of Corneal Abrasion in the Emergency Department

The researchers are trying to understand if the application of a bandage contact lens results in better relief than usual treatment for a corneal abrasion.

Study Overview

• Status: Terminated
• Conditions: Corneal Abrasion
• Intervention / Treatment: Device: Air Optix contact lens

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of Superficial Corneal Abrasion

Exclusion Criteria:

• Incarceration
• Pregnancy
• Inability to Provide Informed Consent
• Infectious keratitis
• Retained foreign bodies in the eye
• Active infection involving the orbit or periorbital region
• Patients who are not able to or who are deemed unlikely to follow-up with ophthalmology
• A history or recent contact lens wear
• A lack of trauma or an unclear history of trauma as the inciting cause of the abrasion
• Allergy to the antimicrobial solution (POLYTRIM)
• Women who are currently breastfeeding
• Chronic eye drop use
• A history of eye surgery other than cataract surgery (greater than 6 months prior to abrasion)
• Diabetes (Patients with even mild diabetic neuropathy can have decreased pain sensation and also delayed corneal epithelial healing)
• Any eye condition that may be deemed to interfere with the conduct of the protocol or outcome measurement.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bandage Contact Lens (BCL) group; Subjects diagnosed with superficial corneal abrasion in the Emergency Department will have a bandage contact lens soaked in antibiotic solution placed in the affected eye	Device: Air Optix contact lens; Contact lens will be placed on the surface of the patient's eye and is to be used as a bandage
No Intervention: Usual Care Group; Subjects diagnosed with superficial corneal abrasion in the Emergency Department will have usual care provided in the Emergency Department

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Score	Measured on scale of 0 being no pain, 5 being moderate pain and 10 being worst pain possible	Baseline, approx. 12-24 hours, approx. 36-48 hours, approx. 1 day, 3 days, and/or 5 days post-discharge

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Robert Hyde, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2019
• Primary Completion (Actual): October 24, 2019
• Study Completion (Actual): October 24, 2019

Study Registration Dates

• First Submitted: November 8, 2019
• First Submitted That Met QC Criteria: November 8, 2019
• First Posted (Actual): November 12, 2019

Study Record Updates

• Last Update Posted (Estimate): January 13, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Corneal Diseases; Facial Injuries; Eye Injuries; Corneal Injuries
• Other Study ID Numbers: 18-009586

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes