search
Back to results

Evaluating the Use of ProKera Plus® in the Management of Bacterial Corneal Ulcers

Primary Purpose

Bacterial Corneal Ulcer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ProProKera Plus®
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Corneal Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Inclusion Criteria

    • Subjects 18 years of age or older, all sexes and races
    • Willing to sign a written informed consent to participate
    • Corneal ulcer criteria: at least 3mm in diameter, opacification located within 3mm of visual axis, infiltrate occupying at least 50% of the corneal thickness, moderate AC cell reaction, clinical picture consistent with bacterial infection later confirmed by culture and gram stain.

Exclusion Criteria:

  • History of Immunodeficiency
  • History of connective tissue disorders or severe atopic disease
  • History of chemical eye injuries
  • History of known limbal stem cell deficiency
  • History of neurotrophic keratopathy
  • History of recent eye surgery, or glaucoma surgery with bleb or drainage tube
  • Risk factors and clinical appearance consistent with fungal keratitis

Sites / Locations

  • University of Arkansas for Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Conventional Treatment

ProKera Plus® Treatment

Arm Description

Corneal ulcer scraping sent for microbial culture Admission to the hospital for initiation of fortified vancomycin 25mg/mL every 1 hour alternating with fortified tobramycin 15mg/mL every 1 hour, preservative free artificial tears every 2 hours, and doxycycline 100mg twice daily. After 48 hours of conventional treatment, consent will be obtained regarding the use of experimental treatment with ProKera Plus® versus continuing conventional method of treatment

1. Experimental Treatment Arm , ProKera Plus® will be placed in the eye with the corneal ulcer

Outcomes

Primary Outcome Measures

Visual Acuity - Visit 1
Visual acuity (VA) was assessed for participants applicable study eye using a Snellen letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity.
Visual Recovery - Visit 2
Visual acuity (VA) was assessed for participants applicable study eye using a Snellen letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity.
Visual Recovery - Visit 3
Visual acuity (VA) was assessed for participants applicable study eye using a Snellen letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity.
Visual Recovery - Visit 4
Visual acuity (VA) was assessed for participants applicable study eye using a Snellen letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity.
Visual Recovery - Visit 5
Visual acuity (VA) was assessed for participants applicable study eye using a Snellen letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity.

Secondary Outcome Measures

Corneal Re-epithelialization - Visit 1
number of participants who had slit lamp photography which measured fluorescein staining size.
Corneal Re-epithelialization - Visit 2
number of participants who had slit lamp photography which measured fluorescein staining size.
Corneal Re-epithelialization - Visit 3
number of participants who had slit lamp photography which measured fluorescein staining size.
Corneal Re-epithelialization - Visit 4
number of participants who had slit lamp photography which measured fluorescein staining size.
Corneal Opacity Size - Visit 1
number of participants who had anterior segment optical coherence tomography (ASOCT).
Corneal Opacity Size - Visit 3
number of participants who had anterior segment optical coherence tomography (ASOCT).
Corneal Opacity Thinning-Visit 1
number of participants who had anterior segment optical coherence tomography (ASOCT).
Corneal Opacity Thinning-Visit 3
number of participants who had anterior segment optical coherence tomography (ASOCT).
Eye Pain- Visit 1
Average pain rating across participants which was assessed subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)
Eye Pain- Visit 2
Average pain rating across participants which was assessed subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)
Eye Pain- Visit 3
Average pain rating across participants which was assessed subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)
Eye Pain- Visit 4
Average pain rating across participants which was assessed subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)
Eye Pain- Visit 5
Average pain rating across participants which was assessed subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)

Full Information

First Posted
April 7, 2021
Last Updated
July 5, 2023
Sponsor
University of Arkansas
search

1. Study Identification

Unique Protocol Identification Number
NCT04850313
Brief Title
Evaluating the Use of ProKera Plus® in the Management of Bacterial Corneal Ulcers
Official Title
A Prospective, Randomized, Controlled Clinical Study to Evaluate the Use of ProKera Plus® in the Management of Bacterial Corneal Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
This study terminated due to slow enrollment
Study Start Date
November 9, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas

4. Oversight

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

5. Study Description

Brief Summary
The study design is a prospective, randomized, controlled interventional study to compare the outcome of ProKera Plus® with conventional treatment in patients with vision-threatening bacterial corneal ulcers. The study will be conducted at the University of Arkansas Medical Sciences (UAMS) in two phases for patients who present to an Ophthalmology clinic or Emergency Department at UAMS.
Detailed Description
Bacterial keratitis is a serious bacterial infection of the cornea, usually caused by a persistent epithelial defect or ulcer that can lead to permanent vision loss from corneal scarring, perforation or endophthalmitis. An infectious corneal ulcer requires immediate treatment with intensive topical fortified broad-spectrum antibiotics to try to eliminate the pathogen. Corneal tissue destruction can be caused directly by infectious agents, the associated inflammatory response, or by ocular toxicity from frequent dosing of fortified antibiotics.1 Sutured amniotic membrane transplantation (AMT) has been shown to reduce pain and promote healing in human bacterial keratitis.2 ProKera® is a sutureless form of CryoTek amniotic membrane that is clipped into a dual polycarbonate ring system with the epithelial side up when in contact with the ocular surface. ProKera Plus® contains a double layer of CryoTek amniotic membrane tissue to provide extra therapeutic benefit. ProKera Plus® has several advantages over sutured AMT including ease of administration in a clinic setting and reduced overall procedural cost. The role of ProKera® in the treatment algorithm of corneal ulcers has yet to be fully clarified. There are currently no prospective case studies comparing the use of ProKera® to standard of care conventional treatments in corneal ulcers. The utility of this device would provide valuable information in the treatment of bacterial corneal ulcers. The objectives are: To determine if ProKera Plus® can lead to better visual recovery when used with bacterial corneal ulcers compared to conventional treatment To determine if ProKera Plus® can actively modify corneal wound healing during the course of managing bacterial corneal ulcers and decrease the overall time to re-epithelialization To determine if ProKera Plus® can decrease pain associated with bacterial corneal ulcers compared to conventional treatment To determine if ProKera Plus® can decrease the amount of corneal opacity and corneal thinning associated with bacterial corneal ulcers compared to conventional treatment To determine if ProKera Plus® can decrease the need for further interventions or surgeries related to complications from bacterial corneal ulcers

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Corneal Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Phase 1: This phase will establish baseline characteristics for each patient that is randomized into the treatment arm for the phase 2 part of the study. Phase 2: This phase will test the intervention of using ProKera Plus® versus continuing conventional treatment for the corneal ulcer
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Treatment
Arm Type
No Intervention
Arm Description
Corneal ulcer scraping sent for microbial culture Admission to the hospital for initiation of fortified vancomycin 25mg/mL every 1 hour alternating with fortified tobramycin 15mg/mL every 1 hour, preservative free artificial tears every 2 hours, and doxycycline 100mg twice daily. After 48 hours of conventional treatment, consent will be obtained regarding the use of experimental treatment with ProKera Plus® versus continuing conventional method of treatment
Arm Title
ProKera Plus® Treatment
Arm Type
Experimental
Arm Description
1. Experimental Treatment Arm , ProKera Plus® will be placed in the eye with the corneal ulcer
Intervention Type
Device
Intervention Name(s)
ProProKera Plus®
Other Intervention Name(s)
ProKera Plus®
Intervention Description
ProKera® is a sutureless form of CryoTek amniotic membrane that is clipped into a dual polycarbonate ring system with the epithelial side up when in contact with the ocular surface.
Primary Outcome Measure Information:
Title
Visual Acuity - Visit 1
Description
Visual acuity (VA) was assessed for participants applicable study eye using a Snellen letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity.
Time Frame
5-day Follow-Up, plus or minus 3 days
Title
Visual Recovery - Visit 2
Description
Visual acuity (VA) was assessed for participants applicable study eye using a Snellen letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity.
Time Frame
16-day follow-up plus or minus 5 days
Title
Visual Recovery - Visit 3
Description
Visual acuity (VA) was assessed for participants applicable study eye using a Snellen letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity.
Time Frame
30-day follow-up plus or minus 7 days
Title
Visual Recovery - Visit 4
Description
Visual acuity (VA) was assessed for participants applicable study eye using a Snellen letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity.
Time Frame
90 day follow-up plus or minus 10 days
Title
Visual Recovery - Visit 5
Description
Visual acuity (VA) was assessed for participants applicable study eye using a Snellen letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity.
Time Frame
180-day follow-up plus or minus 14 days
Secondary Outcome Measure Information:
Title
Corneal Re-epithelialization - Visit 1
Description
number of participants who had slit lamp photography which measured fluorescein staining size.
Time Frame
5-day follow-up plus or minus 3 days
Title
Corneal Re-epithelialization - Visit 2
Description
number of participants who had slit lamp photography which measured fluorescein staining size.
Time Frame
16-day follow-up plus or minus 5 days
Title
Corneal Re-epithelialization - Visit 3
Description
number of participants who had slit lamp photography which measured fluorescein staining size.
Time Frame
30-day follow-up plus or minus 7 days
Title
Corneal Re-epithelialization - Visit 4
Description
number of participants who had slit lamp photography which measured fluorescein staining size.
Time Frame
90-day follow-up plus or minus 10 days
Title
Corneal Opacity Size - Visit 1
Description
number of participants who had anterior segment optical coherence tomography (ASOCT).
Time Frame
5-day follow-up plus or minus 3 days
Title
Corneal Opacity Size - Visit 3
Description
number of participants who had anterior segment optical coherence tomography (ASOCT).
Time Frame
30-day follow-up plus or minus 7 days
Title
Corneal Opacity Thinning-Visit 1
Description
number of participants who had anterior segment optical coherence tomography (ASOCT).
Time Frame
5-day follow-up plus or minus 3 days
Title
Corneal Opacity Thinning-Visit 3
Description
number of participants who had anterior segment optical coherence tomography (ASOCT).
Time Frame
30-day follow-up plus or minus 7 days
Title
Eye Pain- Visit 1
Description
Average pain rating across participants which was assessed subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)
Time Frame
5-day follow-up plus or minus 3 days
Title
Eye Pain- Visit 2
Description
Average pain rating across participants which was assessed subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)
Time Frame
16-day follow-up plus or minus 5 days
Title
Eye Pain- Visit 3
Description
Average pain rating across participants which was assessed subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)
Time Frame
30-day follow-up plus or minus 7 days
Title
Eye Pain- Visit 4
Description
Average pain rating across participants which was assessed subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)
Time Frame
90-day follow-up plus or minus 10 days
Title
Eye Pain- Visit 5
Description
Average pain rating across participants which was assessed subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)
Time Frame
180-day follow-up plus or minus 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion Criteria Subjects 18 years of age or older, all sexes and races Willing to sign a written informed consent to participate Corneal ulcer criteria: at least 3mm in diameter, opacification located within 3mm of visual axis, infiltrate occupying at least 50% of the corneal thickness, moderate AC cell reaction, clinical picture consistent with bacterial infection later confirmed by culture and gram stain. Exclusion Criteria: History of Immunodeficiency History of connective tissue disorders or severe atopic disease History of chemical eye injuries History of known limbal stem cell deficiency History of neurotrophic keratopathy History of recent eye surgery, or glaucoma surgery with bleb or drainage tube Risk factors and clinical appearance consistent with fungal keratitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Warrner, MD
Organizational Affiliation
University Of Arkansas For Medical Sciences, Jones Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluating the Use of ProKera Plus® in the Management of Bacterial Corneal Ulcers

We'll reach out to this number within 24 hrs