Bandage Contact Lens Application for the Management of Corneal Abrasion

• Sponsor: Mayo Clinic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04159714
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 63
• Patients Per Site Per Month: 3.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Corneal Abrasion	Device: Air Optix contact lens	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Sep 10, 2019
• Anticipated Primary Completion Date: Sep 10, 2024
• Anticipated Study Completion Date: Dec 10, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in pain score [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Robert Hyde, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Robert J. Hyde, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT04159714
• Other Study ID Numbers: 18-009586
• First Posted: Nov 12, 2019
• Last Update Posted: Nov 15, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Corneal Injuries

Study Results

No Results Posted as of Nov 15, 2021