Bandage Contact Lens Application for the Management of Corneal Abrasion

NCT04159714 | Terminated Results FDA Device

• 1 other identifier: 18-009586
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Corneal Abrasion

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Bandage Contact Lens (BCL) group

EXPERIMENTAL

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

Usual Care Group

NO INTERVENTION

Subjects diagnosed with superficial corneal abrasion in the Emergency Department will have usual care provided in the Emergency Department

Interventions

Air Optix contact lens DEVICE

Contact lens will be placed on the surface of the patient's eye and is to be used as a bandage

Bandage Contact Lens (BCL) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Superficial Corneal Abrasion

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Corneal Injuries

Condition Hierarchy (Ancestors)

Eye Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Corneal Diseases; Eye Diseases; Wounds and Injuries

Limitations and Caveats

Study terminated due to change in practice decreasing availability of eligible patients.

Results Point of Contact

• Title: Dr. Robert Hyde
• Organization: Mayo Clinic

Hyde.Robert1@mayo.edu

507-255-4137

Study Officials

• Robert Hyde

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 12, 2019
• Study Start: September 10, 2019
• Primary Completion: October 24, 2019
• Study Completion: October 24, 2019
• Last Updated: January 13, 2023
• Results First Posted: January 13, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)