Bandage Contact Lenses for Corneal Abrasions

Bandage Contact Lenses to Decrease Pain and Improve Healing in Emergency Department Subjects Presenting With Corneal Abrasions

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 Overview

• Status: Unknown
• Conditions: Corneal Abrasion; Eye Trauma
• Intervention / Treatment: Drug: Eyedrop; Drug: Hydrocodone; Device: Bandage contact lens

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Torrance, California, United States, 90502
      • Recruiting
      • Harbor-UCLA Medical Center
      • Contact: David Tanen, MD; Phone Number: 210-222-3501; Email: dtanen@emedharbor.edu
      • Sub-Investigator: Pradeep S Prasad, MD
      • Sub-Investigator: Timothy Horeczko, MD
      • Sub-Investigator: Richard H Hoft, MD
      • Sub-Investigator: Bradley Chappell, DO
      • Sub-Investigator: Manpreet Singh, MD
      • Sub-Investigator: Hiroko Akuzawa, MD
      • Sub-Investigator: Debryna D Lumanauw, MD
      • Sub-Investigator: James Archer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; 1. Standard care	Drug: Eyedrop; Fluoroquinolone eyedrops 4x/day; Drug: Hydrocodone; Hydrocone 1-2 tabs 4x/day if needed
Active Comparator: Group 2; Standard care; Bandage contact lens	Drug: Eyedrop; Fluoroquinolone eyedrops 4x/day; Drug: Hydrocodone; Hydrocone 1-2 tabs 4x/day if needed; Device: Bandage contact lens; Bandage contact lenses (BCL) have the advantage of pain reduction, facilitating epithelial healing, and improved surface healing. They have been used in the ophthalmology community to treat post-operative eye pain due to the large corneal abrasion created during Excimer photorefractive keratectomy (PRK), laser in situ keratomileusis (LASIK), and radial keratotomy (RK) with good success. Bandage contact lenses have also been used in studies in Europe through ophthalmology clinics to treat traumatic corneal abrasions with excellent results. A British study from 1987, found that large diameter contact lenses can be fitted satisfactorily without the use of special equipment such as keratometry. Studies in rabbits have also been performed showing improved rates of healing when using bandage contact lenses. BCLs have been used to treat epithelial defects from various causes for up to 7 months at a time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scale	The pain difference using Visual Analogue Scale	24 hours post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal defect size	Reduction in size (mm) of the defect	24 hours post treatment
Pain medication needed	The amount of pain medication needed	24 hours post treatment

Collaborators and Investigators

• Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: June 29, 2017
• First Submitted That Met QC Criteria: June 29, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): February 1, 2018
• Last Update Submitted That Met QC Criteria: January 31, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: contact lens; corneal abrasion; eye trauma
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Corneal Diseases; Facial Injuries; Corneal Injuries; Eye Injuries; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Respiratory System Agents; Pharmaceutical Solutions; Antitussive Agents; Ophthalmic Solutions; Hydrocodone
• Other Study ID Numbers: 30610-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPD will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No