Bandage Contact Lenses for Corneal Abrasions

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Status and phase: Unknown; Phase 2

Conditions: Eye Trauma; Corneal Abrasion

Treatments: Device: Bandage contact lens; Drug: Hydrocodone; Drug: Eyedrop

Study type: Interventional

Funder types: Other

Identifiers

NCT03206723

30610-01

Details and patient eligibility

About

Two percent of all patients presenting to the Emergency Departments have complaints involving the eye. Corneal abrasions are a common diagnosis with patients with eye pain and often cause significant discomfort. Current treatment includes a thorough evaluation of the eye followed by patching, empiric antibiotics, cycloplegics and oral pain medicines. This study will be a randomized controlled trial to determine the safety and efficacy of BCLs. It will involve the initial patient evaluation followed by a return visit to the Emergency Department within 36 hours for re-examination. At each visit, the patient will be assessed for the size and location of the abrasion along with their report of pain using a visual analog scale. Data will be recorded on a standard data collection sheet. Telephone contact will be made at 30 days to ensure resolution of abrasion and that no complications ensued.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects between ages 18-65 years who present to the emergency department.
• Traumatic corneal abrasion not associated with contact lens use or communicating or adjacent wounds to the eye.

Exclusion criteria

• Pregnant women
• Breast-feeding women
• Corneal abrasion associated with the wearing contact lenses
• Evidence of corneal ulcer, glaucoma or other ocular pathology, monocular vision
• Wound healing deficits such as collagen vascular disease or concomitant steroid use
• Use of other ocular medications, dry eyes, blepharitis
• Systemic infections
• Known allergies to medicines used in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Group 1

Active Comparator group

Description:

1. Standard care

Treatment:

Drug: Eyedrop

Drug: Hydrocodone

Group 2

Active Comparator group

Description:

1. Standard care 2. Bandage contact lens

Treatment:

Drug: Eyedrop

Drug: Hydrocodone

Device: Bandage contact lens