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Clinical Trials/NCT04159714
NCT04159714TerminatedNot Applicable

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

Mayo Clinic2 sites in 1 country1 target enrollmentStarted: September 10, 2019Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
1
Locations
2
Primary Endpoint
Change in Pain Score
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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.

Outcomes

Primary Outcomes

Change in Pain Score

Time Frame: 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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Robert J. Hyde

Principal Investigator

Mayo Clinic

Study Sites (2)

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