Recruiting
Phase 2

Bandage Contact Lenses

Sponsor:

UCLA

Code:

NCT03206723

Conditions

Corneal Abrasion

Eye Trauma

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Bandage contact lens

Eyedrop

Hydrocodone

Study Details

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 ID

NCT03206723

Start date

Jul 1, 2017

Status verified date

Jan, 2018

Completion date

Mar 1, 2019

Anticipated

Primary completion date

Dec 31, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Group 1

1. Standard care

active comparator: Group 2

1. Standard care
2. Bandage contact lens

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.

Eyedrop

Fluoroquinolone eyedrops 4x/day

Hydrocodone

Hydrocone 1-2 tabs 4x/day if needed

Primary outcome measure

  • Pain scale [ Time Frame: 24 hours post treatment ]

Central Contacts and Locations

Central contacts

David Tanen, MD

3102223501dtanen@labiomed.org

Locations

Harbor-UCLA Medical Center

Recruiting

Torrance, California, United States, 90502

Contacts

David Tanen, MD

210-222-3501dtanen@emedharbor.edu

More Information

Sponsor

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Last update posted

Feb 1, 2018

Last verified

Jan, 2018

Keywords

  • corneal abrasion
  • contact lens
  • eye trauma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center on 2018-02-01.