Bandage Contact Lenses for Corneal Abrasions

NCT ID: NCT03206723

Last Updated: 2018-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2019-03-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

1\. Standard care

Group Type: ACTIVE_COMPARATOR

Eyedrop

Intervention Type: DRUG

Fluoroquinolone eyedrops 4x/day

Hydrocodone

Intervention Type: DRUG

Hydrocone 1-2 tabs 4x/day if needed

Group 2

1. Standard care

2. Bandage contact lens

Group Type: ACTIVE_COMPARATOR

Bandage contact lens

Intervention Type: 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.

Eyedrop

Intervention Type: DRUG

Fluoroquinolone eyedrops 4x/day

Hydrocodone

Intervention Type: DRUG

Hydrocone 1-2 tabs 4x/day if needed

Interventions

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.

Intervention Type: DEVICE

Eyedrop

Fluoroquinolone eyedrops 4x/day

Intervention Type: DRUG

Hydrocodone

Hydrocone 1-2 tabs 4x/day if needed

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

OTHER

Sponsor Role: lead

Responsible Party

David Tanen

Professor of Clinical X

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Harbor-UCLA Medical Center

Torrance, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

David Tanen, MD

Role: CONTACT

dtanen@labiomed.org

3102223501

Facility Contacts

David Tanen, MD

Role: primary

dtanen@emedharbor.edu

210-222-3501

Other Identifiers

30610-01

Identifier Type: -

Identifier Source: org_study_id