Skip to content

Bandage Contact Lenses for Corneal Abrasions

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03206723
Enrollment
60
Registered
2017-07-02
Start date
2017-07-01
Completion date
2019-03-01
Last updated
2018-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Abrasion, Eye Trauma

Keywords

corneal abrasion, contact lens, eye trauma

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.

Interventions

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.

DRUGEyedrop

Fluoroquinolone eyedrops 4x/day

Hydrocone 1-2 tabs 4x/day if needed

Sponsors

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Pain scale24 hours post treatmentThe pain difference using Visual Analogue Scale

Secondary

MeasureTime frameDescription
Corneal defect size24 hours post treatmentReduction in size (mm) of the defect
Pain medication needed24 hours post treatmentThe amount of pain medication needed

Countries

United States

Contacts

Primary ContactDavid Tanen, MD
dtanen@labiomed.org3102223501

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026