Bandage Contact Lenses for Corneal Abrasions

NCT03206723 | Unknown Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: 30610-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Corneal Abrasion; Eye Trauma

Keywords

corneal abrasion; contact lens; eye trauma

Outcome Measures

Primary Outcomes (1)

• Pain scale

  The pain difference using Visual Analogue Scale

  24 hours post treatment

Secondary Outcomes (2)

• Corneal defect size

  24 hours post treatment

• Pain medication needed

  24 hours post treatment

Study Arms (2)

Group 1

ACTIVE COMPARATOR

1\. Standard care

Drug: Eyedrop; Drug: Hydrocodone

Group 2

ACTIVE COMPARATOR

1. Standard care 2. Bandage contact lens

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

Interventions

Bandage contact lens DEVICE

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.

Group 2

Eyedrop DRUG

Fluoroquinolone eyedrops 4x/day

Group 1; Group 2

Hydrocodone DRUG

Hydrocone 1-2 tabs 4x/day if needed

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Harbor-UCLA Medical Center

Torrance, California, 90502, United States

RECRUITING

MeSH Terms

Conditions

Corneal Injuries; Eye Injuries

Interventions

Ophthalmic Solutions; Hydrocodone

Condition Hierarchy (Ancestors)

Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Corneal Diseases; Eye Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

David Tanen, MD

CONTACT

3102223501; dtanen@labiomed.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical X

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: July 2, 2017
• Study Start: July 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: March 1, 2019
• Last Updated: February 1, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)