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

July 5, 2023 updated by: University of Arkansas

A Prospective, Randomized, Controlled Clinical Study to Evaluate the Use of ProKera Plus® in the Management of Bacterial Corneal Ulcers

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

  1. To determine if ProKera Plus® can lead to better visual recovery when used with bacterial corneal ulcers compared to conventional treatment
  2. 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
  3. To determine if ProKera Plus® can decrease pain associated with bacterial corneal ulcers compared to conventional treatment
  4. To determine if ProKera Plus® can decrease the amount of corneal opacity and corneal thinning associated with bacterial corneal ulcers compared to conventional treatment
  5. To determine if ProKera Plus® can decrease the need for further interventions or surgeries related to complications from bacterial corneal ulcers

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Conventional Treatment
  • 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
Experimental: ProKera Plus® Treatment
1. Experimental Treatment Arm , ProKera Plus® will be placed in the eye with the corneal ulcer
Device: ProProKera Plus®
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.
Other Names:
  • ProKera Plus®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Acuity - Visit 1
Time Frame: 5-day Follow-Up, plus or minus 3 days
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.
5-day Follow-Up, plus or minus 3 days
Visual Recovery - Visit 2
Time Frame: 16-day follow-up plus or minus 5 days
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.
16-day follow-up plus or minus 5 days
Visual Recovery - Visit 3
Time Frame: 30-day follow-up plus or minus 7 days
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.
30-day follow-up plus or minus 7 days
Visual Recovery - Visit 4
Time Frame: 90 day follow-up plus or minus 10 days
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.
90 day follow-up plus or minus 10 days
Visual Recovery - Visit 5
Time Frame: 180-day follow-up plus or minus 14 days
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.
180-day follow-up plus or minus 14 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Corneal Re-epithelialization - Visit 1
Time Frame: 5-day follow-up plus or minus 3 days
number of participants who had slit lamp photography which measured fluorescein staining size.
5-day follow-up plus or minus 3 days
Corneal Re-epithelialization - Visit 2
Time Frame: 16-day follow-up plus or minus 5 days
number of participants who had slit lamp photography which measured fluorescein staining size.
16-day follow-up plus or minus 5 days
Corneal Re-epithelialization - Visit 3
Time Frame: 30-day follow-up plus or minus 7 days
number of participants who had slit lamp photography which measured fluorescein staining size.
30-day follow-up plus or minus 7 days
Corneal Re-epithelialization - Visit 4
Time Frame: 90-day follow-up plus or minus 10 days
number of participants who had slit lamp photography which measured fluorescein staining size.
90-day follow-up plus or minus 10 days
Corneal Opacity Size - Visit 1
Time Frame: 5-day follow-up plus or minus 3 days
number of participants who had anterior segment optical coherence tomography (ASOCT).
5-day follow-up plus or minus 3 days
Corneal Opacity Size - Visit 3
Time Frame: 30-day follow-up plus or minus 7 days
number of participants who had anterior segment optical coherence tomography (ASOCT).
30-day follow-up plus or minus 7 days
Corneal Opacity Thinning-Visit 1
Time Frame: 5-day follow-up plus or minus 3 days
number of participants who had anterior segment optical coherence tomography (ASOCT).
5-day follow-up plus or minus 3 days
Corneal Opacity Thinning-Visit 3
Time Frame: 30-day follow-up plus or minus 7 days
number of participants who had anterior segment optical coherence tomography (ASOCT).
30-day follow-up plus or minus 7 days
Eye Pain- Visit 1
Time Frame: 5-day follow-up plus or minus 3 days
Average pain rating across participants which was assessed subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)
5-day follow-up plus or minus 3 days
Eye Pain- Visit 2
Time Frame: 16-day follow-up plus or minus 5 days
Average pain rating across participants which was assessed subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)
16-day follow-up plus or minus 5 days
Eye Pain- Visit 3
Time Frame: 30-day follow-up plus or minus 7 days
Average pain rating across participants which was assessed subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)
30-day follow-up plus or minus 7 days
Eye Pain- Visit 4
Time Frame: 90-day follow-up plus or minus 10 days
Average pain rating across participants which was assessed subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)
90-day follow-up plus or minus 10 days
Eye Pain- Visit 5
Time Frame: 180-day follow-up plus or minus 14 days
Average pain rating across participants which was assessed subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)
180-day follow-up plus or minus 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Arkansas

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Warrner, MD, University Of Arkansas For Medical Sciences, Jones Eye Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 9, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 262292

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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