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Bandage Contact Lenses for Corneal Abrasions

Primary Purpose

Corneal Abrasion, Eye Trauma

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bandage contact lens
Eyedrop
Hydrocodone
Sponsored by
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corneal Abrasion focused on measuring corneal abrasion, contact lens, eye trauma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Harbor-UCLA Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

1. Standard care

Standard care Bandage contact lens

Outcomes

Primary Outcome Measures

Pain scale
The pain difference using Visual Analogue Scale

Secondary Outcome Measures

Corneal defect size
Reduction in size (mm) of the defect
Pain medication needed
The amount of pain medication needed

Full Information

First Posted
June 29, 2017
Last Updated
January 31, 2018
Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03206723
Brief Title
Bandage Contact Lenses for Corneal Abrasions
Official Title
Bandage Contact Lenses to Decrease Pain and Improve Healing in Emergency Department Subjects Presenting With Corneal Abrasions
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
March 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Abrasion, Eye Trauma
Keywords
corneal abrasion, contact lens, eye trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
1. Standard care
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Standard care Bandage contact lens
Intervention Type
Device
Intervention Name(s)
Bandage contact lens
Intervention Description
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
Drug
Intervention Name(s)
Eyedrop
Intervention Description
Fluoroquinolone eyedrops 4x/day
Intervention Type
Drug
Intervention Name(s)
Hydrocodone
Intervention Description
Hydrocone 1-2 tabs 4x/day if needed
Primary Outcome Measure Information:
Title
Pain scale
Description
The pain difference using Visual Analogue Scale
Time Frame
24 hours post treatment
Secondary Outcome Measure Information:
Title
Corneal defect size
Description
Reduction in size (mm) of the defect
Time Frame
24 hours post treatment
Title
Pain medication needed
Description
The amount of pain medication needed
Time Frame
24 hours post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Tanen, MD
Phone
3102223501
Email
dtanen@labiomed.org
Facility Information:
Facility Name
Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Tanen, MD
Phone
210-222-3501
Email
dtanen@emedharbor.edu
First Name & Middle Initial & Last Name & Degree
Pradeep S Prasad, MD
First Name & Middle Initial & Last Name & Degree
Timothy Horeczko, MD
First Name & Middle Initial & Last Name & Degree
Richard H Hoft, MD
First Name & Middle Initial & Last Name & Degree
Bradley Chappell, DO
First Name & Middle Initial & Last Name & Degree
Manpreet Singh, MD
First Name & Middle Initial & Last Name & Degree
Hiroko Akuzawa, MD
First Name & Middle Initial & Last Name & Degree
Debryna D Lumanauw, MD
First Name & Middle Initial & Last Name & Degree
James Archer

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared.

Learn more about this trial

Bandage Contact Lenses for Corneal Abrasions

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