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Bandage Contact Lens Application for the Management of Corneal Abrasion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04159714
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : November 12, 2019
Sponsor:
Information provided by (Responsible Party):
Robert J. Hyde, Mayo Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Corneal Abrasion Device: Air Optix contact lens Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bandage Contact Lens Application for the Management of Corneal Abrasion in the Emergency Department
Actual Study Start Date : September 10, 2019
Estimated Primary Completion Date : September 10, 2024
Estimated Study Completion Date : December 10, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

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



Primary Outcome Measures :
  1. Change in pain score [ Time Frame: Baseline, approx. 12-24 hours, approx. 36-48 hours, approx. 1 day, 3 days, and/or 5 days post-discharge ]
    Measured on scale of 0 being no pain, 5 being moderate pain and 10 being worst pain possible



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159714


Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Kaitlin Lundell    507-255-5056    Lundell.Kaitlin@mayo.edu   
Principal Investigator: Robert Hyde, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Robert Hyde Mayo Clinic
Additional Information:
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Responsible Party: Robert J. Hyde, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04159714    
Other Study ID Numbers: 18-009586
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes