Bandage Contact Lenses for Corneal Abrasions

Corneal Abrasion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03206723
• Other study ID #: 30610-01
• Status: Recruiting
• Phase: Phase 2
• First received: June 29, 2017
• Last updated: January 31, 2018
• Start date: July 1, 2017
• Est. completion date: March 1, 2019

Study information

• Verified date: January 2018
• Source: Los Angeles Biomedical Research Institute
• Contact: David Tanen, MD
• Phone: 3102223501
• Email: dtanen[@]labiomed.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 1, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Corneal Abrasion
• Eye Injuries
• Eye Trauma

Intervention

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.

Drug:
• Eyedrop
Fluoroquinolone eyedrops 4x/day
• Hydrocodone
Hydrocone 1-2 tabs 4x/day if needed

Locations

Country	Name	City	State
United States	Harbor-UCLA Medical Center	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Los Angeles Biomedical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scale	The pain difference using Visual Analogue Scale	24 hours post treatment
Secondary	Corneal defect size	Reduction in size (mm) of the defect	24 hours post treatment
Secondary	Pain medication needed	The amount of pain medication needed	24 hours post treatment