Bandage Contact Lenses for Corneal Abrasions

Phase 2

• Conditions: Corneal Abrasion; Eye Trauma
• Interventions: Drug: Eyedrop; Device: Bandage contact lens; Drug: Hydrocodone

• Registration Number: NCT03206723
• Lead Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-29
• Study First Submitted QC: 2017-06-29
• Study Start: 2017-07-01
• Study First Posted: 2017-07-02
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-31
• Last Update Posted: 2018-02-01
• Primary Completion: 2018-12-31
• Study Completion: 2019-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Hydrocodone	1. Standard care
Group 2	Hydrocodone	1. Standard care 2. Bandage contact lens
Group 1	Eyedrop	1. Standard care
Group 2	Bandage contact lens	1. Standard care 2. Bandage contact lens
Group 2	Eyedrop	1. Standard care 2. Bandage contact lens

Primary Outcome Measures

Name	Time	Method
Pain scale	24 hours post treatment	The pain difference using Visual Analogue Scale

Secondary Outcome Measures

Name	Time	Method
Corneal defect size	24 hours post treatment	Reduction in size (mm) of the defect
Pain medication needed	24 hours post treatment	The amount of pain medication needed

Trial Locations

Locations (1)

Harbor-UCLA Medical Center; 🇺🇸 Torrance, California, United States