Bandage Contact Lenses to Decrease Pain and Improve Healing in Emergency Department Subjects Presenting With Corneal Abrasions
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Pain scale
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Group 1
- Standard care
Intervention: Eyedrop (Drug)
Group 1
- Standard care
Intervention: Hydrocodone (Drug)
Group 2
- Standard care
- Bandage contact lens
Intervention: Bandage contact lens (Device)
Group 2
- Standard care
- Bandage contact lens
Intervention: Eyedrop (Drug)
Group 2
- Standard care
- Bandage contact lens
Intervention: Hydrocodone (Drug)
Outcomes
Primary Outcomes
Pain scale
Time Frame: 24 hours post treatment
The pain difference using Visual Analogue Scale
Secondary Outcomes
- Corneal defect size(24 hours post treatment)
- Pain medication needed(24 hours post treatment)
Investigators
David Tanen
Professor of Clinical X
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center