Bandage Contact Lens Application for the Management of Corneal Abrasion

NCT ID: NCT04159714

Last Updated: 2023-01-13

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-10

Study Completion Date

2019-10-24

Brief Summary

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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.

Detailed Description

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Conditions

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Corneal Abrasion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Air Optix contact lens

Intervention Type DEVICE

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

Usual Care Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Robert J. Hyde

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Hyde

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Related Links

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Other Identifiers

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18-009586

Identifier Type: -

Identifier Source: org_study_id

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