Back to resultsBandage Contact Lens Application for the Management of Corneal Abrasion
Primary Purpose
Corneal Abrasion
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Air Optix contact lens
Sponsored by
About this trial
This is an interventional treatment trial for Corneal Abrasion
Eligibility 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.
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Bandage Contact Lens (BCL) group
Usual Care Group
Arm Description
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
Subjects diagnosed with superficial corneal abrasion in the Emergency Department will have usual care provided in the Emergency Department
Outcomes
Primary Outcome Measures
Change in Pain Score
Measured on scale of 0 being no pain, 5 being moderate pain and 10 being worst pain possible
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04159714
Brief Title
Bandage Contact Lens Application for the Management of Corneal Abrasion
Official Title
Bandage Contact Lens Application for the Management of Corneal Abrasion in the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
Change in practice decreasing availability of eligible patients.
Study Start Date
September 10, 2019 (Actual)
Primary Completion Date
October 24, 2019 (Actual)
Study Completion Date
October 24, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Abrasion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bandage Contact Lens (BCL) group
Arm Type
Experimental
Arm Description
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
Arm Title
Usual Care Group
Arm Type
No Intervention
Arm Description
Subjects diagnosed with superficial corneal abrasion in the Emergency Department will have usual care provided in the Emergency Department
Intervention Type
Device
Intervention Name(s)
Air Optix contact lens
Intervention Description
Contact lens will be placed on the surface of the patient's eye and is to be used as a bandage
Primary Outcome Measure Information:
Title
Change in Pain Score
Description
Measured on scale of 0 being no pain, 5 being moderate pain and 10 being worst pain possible
Time Frame
Baseline, approx. 12-24 hours, approx. 36-48 hours, approx. 1 day, 3 days, and/or 5 days post-discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Hyde
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Bandage Contact Lens Application for the Management of Corneal Abrasion
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