Bandage Contact Lens Application for the Management of Corneal Abrasion

Corneal Abrasion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04159714
• Other study ID #: 18-009586
• Status: Terminated
• Phase: N/A
• Start date: September 10, 2019
• Est. completion date: October 24, 2019

Study information

• Verified date: December 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: October 24, 2019
• Est. primary completion date: October 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Corneal Abrasion
• Corneal Injuries

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Mayo Clinic Clinical Trials