A Prospective, Randomized, Controlled Clinical Study to Evaluate the Use of ProKera Plus® in the Management of Bacterial Corneal Ulcers
Phase: NA
Conditions: Bacterial Corneal Ulcer
Sponsor: University of Arkansas

A Prospective, Randomized, Controlled Pilot Clinical Study to Evaluate the Use of ProKera Plus®  
                                                           in the Management of Bacterial Corneal Ulcers  
PI: Dr. David Warner 
 
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Study Title: 
A Prospective, Randomized, Controlled Pilot Clinical Study to Evaluate the Use 
of ProKera Plus® in the Management of Bacterial Corneal Ulcers 
 
Principal Investigator:  
David B Warner M.D.  
University of Arkansas for Medical Sciences 
4301 W. Markham Street 
Little Rock, AR 72205 
Telephone:  501.686.5822 
Email:  dbwarner@uams.edu 
 
Co-Investigators: 
Heather V Broyles D.O.  
 
University of Arkansas for Medical Sciences 
  
4301 W. Markham Street 
Little Rock, AR 72205 
Telephone:  501.686.5822 
Email:  hvbroyles@uams.edu 
 
William Henry, M.D. 
 
University of Arkansas for Medical Sciences 
  
4301 W. Markham Street 
Little Rock, AR 72205 
Telephone:  501.686.5822 
Email:  wahenry@uams.edu 
 
 
 
Study Coordinators: 
Jeremy Lemmons 
 
University of Arkansas for Medical Sciences 
  
4301 W. Markham Street 
Little Rock, AR 72205 
Telephone:  501-296-1156 
Email: JDLemmons2@uams.edu 
 
 
 
 
 
Study location: 
University of Arkansas for Medical Sciences 
 
4301 W. Markham Street 
Little Rock, AR 72205 
 
 
 
 

A Prospective, Randomized, Controlled Pilot Clinical Study to Evaluate the Use of ProKera Plus®  
                                                           in the Management of Bacterial Corneal Ulcers  
PI: Dr. David Warner 
 
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Background and Rationale 
 
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.  
Several retrospective case reports have shown that ProKera® can facilitate resolution of pain and 
inflammation and promote rapid epithelization.3 However, 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. Our Main goal is to 
estimate standard deviation of our outcomes in order to design a larger clinical trial to more 
accurately address these objectives 
 
Objectives 
 
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 Design and Procedures  
 
This is a pilot study meant to gather information needed to design a larger, prospective, randomized, 
controlled clinical trial. A total of N=24 patients (12 per treatment arm) will be required for this pilot study. 

A Prospective, Randomized, Controlled Pilot Clinical Study to Evaluate the Use of ProKera Plus®  
                                                           in the Management of Bacterial Corneal Ulcers  
PI: Dr. David Warner 
 
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There may be up to 30 patients consented to reach this total. The pilot 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 to answer the objectives stated above. 
Patients who present to an Ophthalmology clinic or Emergency Department at UAMS with a severe corneal 
ulcer based on the inclusion criteria will be evaluated and initially treated in the conventional, standard of 
care methods as follows: 
- The patient’s name, date of birth and medical record number will be accessed to enter the standard 
consult note in the EMR chart.  
- 
The patient’s past medical, ocular, surgical and family history will be obtained including the following 
historical information: medications patients takes, any medications allergies, if the patient smokes, drinks 
alcohol or uses recreational drugs, if the patient has ever been diagnosed with any eye condition or 
disease, any history of eye infections or eye surgeries including glaucoma surgery, and history of eye 
trauma or chemicals in the eye, if patient has ever worn contact lenses and if so how often they are 
worn/cleaned/changed/where they are bought, and recent exposure to pools, lakes or outside matter and 
any high risk sexual behavior (this information will help determine initial eligibility as well as subsequent 
data analyses.  
 Visual acuity, pupil check, extraocular motility, and intraocular pressure will be recorded. An 
anterior segment exam will be recorded using a slit-lamp. Dilating eye drops will be administered and 
dilated fundus exam will be obtained. If the ulcer is impeding view of the fundus, an ocular ultrasound will 
be performed to evaluate the posterior segment. All of this information will be documented in the consult 
note. 
-  
Corneal ulcer scraping sent for microbial culture 
- 
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, 
with outpatient follow-up every 1-3 days at the UAMS Ophthalmology clinic or in the hospital if admitted for 
the above regimen based on clinical severity.  
 
Phase 1: This phase of the pilot study will establish baseline characteristics for each patient that is 
randomized into the treatment arm for the phase 2 part of the study.  
- 
After at least 48 hours of conventional treatment as described above, consent will be obtained 
regarding the use of experimental treatment with ProKera Plus® versus continuing conventional 
method of treatment. This will be randomized in a 1:1 ratio (n=12/group) by a block-randomization 
schedule to assign subjects to each of the two treatment groups.  The master randomization 
schedule will be generated from sealed envelope.com prior to the start of the study, and the master 
randomization list will be kept in the Trial Master File. A set of tamper-evident envelopes will be 
created and each have the trial identification and a sequential number on it. Inside is the specific 
treatment allocation as determined by the Master Randomization List. The envelopes are to be kept 
private, and to only reveal a treatment allocation after receiving information demonstrating that the 
patient is eligible and has consented to the trial. After assessing subject’s eligibility and consent, the 
next envelope in sequence is opened. 

A Prospective, Randomized, Controlled Pilot Clinical Study to Evaluate the Use of ProKera Plus®  
                                                           in the Management of Bacterial Corneal Ulcers  
PI: Dr. David Warner 
 
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- 
At this time, each patient will undergo baseline slit-lamp photography with and without fluorescein 
staining, as well as anterior segment optical coherence tomography (ASOCT). These will be 
recorded in the patient’s existing medical chart for the hospital encounter. 
- 
Each patient will be in the study for 6 months. It will include continued outpatient follow-up in clinic 
for approximately 5-7 days or continued hospitalization for approximately 5-7 days if necessary, and 
2 mandatory clinic visits that will happen on approximately day 16 and day 30 of the study. 
Additional clinic visits will be scheduled for approximately 3 months and 6 months for visual acuity 
and Slit Lamp exam, and a survey will be sent instead if patient is unable to physically come to 
clinic.  
 
 
Phase 2: This phase of the pilot study will test the intervention of using ProKera Plus® versus continuing 
conventional treatment for the corneal ulcer as follows: 
- 
Experimental Treatment Arm (determined at random as mentioned above) → ProKera Plus® will be 
placed in the eye with the corneal ulcer. Eye drops will then be adjusted based on culture speciation 
and sensitivities, and decreased to 4 times daily. If patient is being followed on an outpatient basis, 
they will be evaluated every 1-3 days for 5-7 days then be seen in clinic for repeat slit-lamp 
photography with and without fluorescein staining. If the patient is still hospitalized during this time, 
the patient will be evaluated every 1-3 days and brought to clinic prior to discharge. At this last visit 
before discharge, pain level will be assessed; in addition we will repeat slit-lamp photography with 
and without fluorescein staining The ProKera Plus® will be exchanged or replaced if it becomes 
cloudy or melts 
1. Active Comparator Control Arm → Standard of care eye drops will be adjusted based on culture 
speciation and sensitivities. If culture speciation is not available at 48 hours, eye drops will decrease 
to every 2 hours. If speciation has resulted, eye drop regimen will be adjusted to either every 2 
hours or 4 times daily depending on the severity. If the patient is being followed on an outpatient 
basis, they will be seen in clinic every 1-3 days for 5-7 days and at one visit we will repeat slit-lamp 
photography with and without fluorescein staining. If the patient is still hospitalized, they will continue 
to be evaluated every 1-3 days for approximately 5-7 days, and brought to clinic prior to discharge. 
At this last visit before discharge, pain level will be assessed and we will repeat slit-lamp 
photography with and without fluorescein staining. 
2. For the patients that are hospitalized, they will be discharged from the hospital approximately 5 (+/-
3) days from the start of the study based on demonstrated improvement, and seen in the clinic prior 
to discharge. This will be given there are no other conditions keeping patient hospitalized at this 
time. 
3. The following will be obtained at visit 3(refer to protocol table): subjective data including pain level 
and subjective visual improvement, and objective data including visual acuity, slit-lamp photography 
with and without fluorescein, and ASOCT. 
4. The following will be obtained at visit 4(refer to protocol table): subjective data including pain level, 
subjective visual improvement, and objective data including visual acuity, slit-lamp photography with 
and without fluorescein. Additional visits may be scheduled if wound healing is delayed and patient 

A Prospective, Randomized, Controlled Pilot Clinical Study to Evaluate the Use of ProKera Plus®  
                                                           in the Management of Bacterial Corneal Ulcers  
PI: Dr. David Warner 
 
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requires closer follow-up. 
5. Visits 5 & 6(refer to protocol table) are the only visits that are solely for research purposes. If the 
patient is unable to come to an in-person clinic visit at this time, a patient questionnaire will be 
mailed instead which evaluates pain and visual acuity on a subjective level. If the patient is able to 
come to clinic, the questionnaire will be done in person, objective visual acuity will be obtained as 
well as a slit lamp exam and pain assessment.   
 
 
Primary Outcome Measures: 
1. 
Visual Recovery [ Data points: Day of presentation, visits 1, 2, 3, and 4; visits 5 and 6 only if patient 
is able to make it to these visits in person]  
• 
Measured by the Traditional Snellen Eye Chart or Revised 2000 Series ETDRS charts (Precision 
Vision, La Salle, Illinois, USA) recorded values of anywhere from 20/20 to 20/400 or count fingers vs hand 
motion vision in front of face. These values will be converted to logarithm of the minimum angle of 
resolution (logMar) for statistical analysis 
 
Secondary Outcome Measures:  
2. 
Corneal Re-epithelialization [Data points: Visits 1, 2, 3, and 4]  
• 
Measured by fluorescein staining size on examination using slit lamp photography 
 
3.  
Corneal Opacity size and Thinning [Data points: Visits 1 and 3] 
• 
Measured by ASOCT  
  
4. 
Pain [Data points: At day of presentation and at visits 1, 2, 3, and 4; visits 5 and 6 only if patient is 
able to make it to these visits in person]  
• 
Assessed subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst 
possible pain) 
 
5. 
Complications/Adverse Events [Time Frame: up to 3 months after initial treatment] 
• 
Quantified by need for additional procedures such as corneal gluing or corneal transplantation due 
to corneal perforation, need for vitreous tap/inject for development of endophthalmitis, or any additional 
surgical procedure necessitated by infection. In addition, there will be documentation and quantification of 
any adverse event from the insertion of the ProKera Plus® including but not limited to cloudy vision while 
inserted, allergic reaction, inability to completely blink or close the eyelid with possible need for tape to 
close eyelids, or any new microbial infection or transmission of viral disease.  
 

A Prospective, Randomized, Controlled Pilot Clinical Study to Evaluate the Use of ProKera Plus®  
                                                           in the Management of Bacterial Corneal Ulcers  
PI: Dr. David Warner 
 
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6.    
A questionnaire, constructed by the study team, will be given to participants at visits 5 & 6.(see 
attached) 
 
Study Population 
The study population will consist of all patients ages 18 or older who present to the ophthalmology 
consulting service or ophthalmology eye clinic for eye care at University of Arkansas for the Medical 
Sciences.  
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, and clinical 
picture consistent with bacterial infection.  
 
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 
• History of drug reactions to Ciprofloxacin or Amphotericin B 
• Risk factors and clinical appearance consistent with fungal keratitis 
• Visual acuity that is greater than 20/40 
• Visual acuity that is light perception or worse  
 
Risks and Benefits 
 
A risk to study participants is the potential for loss of confidentiality of study data.  Measures to protect the 
confidentiality of study data will be implemented as described in the Data Handling and Recordkeeping 
section below. 
Potential risks include possible discomfort with insertion of ProKera Plus® and cloudy vision while inserted, 
allergic reaction if drug allergies to Ciprofloxacin or Amphotericin B, inability to completely blink or close the 
eyelid with possible need for tape to close eyelids, and rare possibility of microbial infection and 
transmission of viral disease through the donor tissue although unlikely 
Potential benefits include decreased pain, ability to decrease eye drop frequency, decreased corneal 
scarring and therefore possible increased chance of visual recovery.  
Knowledge gained from the study could potentially benefit patients in the future and determine the utility of 
ProKera Plus® in treating bacterial corneal ulcers as part of standard-of-care treatment for severe ulcers. 

A Prospective, Randomized, Controlled Pilot Clinical Study to Evaluate the Use of ProKera Plus®  
                                                           in the Management of Bacterial Corneal Ulcers  
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Data Handling and Recordkeeping 
 
The Principal Investigator will carefully monitor study procedures to protect the safety of research subjects, 
the quality of the data and the integrity of the study.  All study subject material will be assigned a unique 
identifying number. The key to the code will kept in a locked file in the Principal Investigator’s office. Only 
the Principal Investigator Dr. Warner, Dr. Broyles and Dr. Henry will have access to the code.  
Data safety monitoring will involve the following: any feedback, complaint, error or accidents that may 
possibly occur during the trial will be reported to UAMS and Tissue Tech company. In addition any adverse 
event that may occur during the trial will be properly monitored by the following: if potentially attributable to 
the ProKera Plus®, a description of the adverse event, the date if occurred, and the serial number and 
expiration date of the device will be recorded and mailed to Tissue Tech.  
During the study, the information collected will be obtained from EMR on UAMS servers and de-identified  
and stored on research service drive (encrypted database/spreadsheet) on UAMS servers. Dr. David 
Warner, Dr. Heather Broyles, and Dr. Will Henry will have access to the research service drive. In addition, 
the de-identified data including all measurements and data obtained from the primary and secondary 
outcomes will be shared with Tissue Tech.  
At the conclusion of the study, the information will be permanently de-identified. The information will be 
kept on site for a minimum of 7 years according to UAMS policy. The records will be destroyed according 
to current HIPAA regulations and institution policy.  
 
Specimen Handling and Storage  
 
The specimens obtained from the patient include corneal ulcer wound scrapings done at bedside and 
plated Blood Agar Plate, Chocolate Agar and Potato Dextrose Agar Plates. This is part of the normal 
clinical standard-of-care that will occur regardless of study participation. These specimens will be walked 
over to the clinical microbiology lab at UAMS as part of routine care 
The ProKera Plus® will be obtained from Tissue Tech Inc. It will be stored in the tissue freezer at -80ºC to 
4ºC. After being thawed at room temperature for five minutes, the ProKera Plus® will be rinsed with saline 
solution and inserted at the bedside after topical application of 0.5% proparacaine hydrochloride. 
The ProKera Plus® will be removed when measuring visual acuity and for photographic documentation 
and reinserted afterwards. It will be exchanged or replaced when it becomes torn, cloudy, or melts. 
 
Statistical Considerations: 
 
Sample Size:  A total of N=24 patients (12 per treatment arm) will be required for this pilot study.  With this 
sample size, we can get robust variance estimates for the primary and secondary outcomes of interest.  

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                                                           in the Management of Bacterial Corneal Ulcers  
PI: Dr. David Warner 
 
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We intend to use a one-sided 80% upper confidence limit (UCL) of the sample standard deviation (s) 
estimated from this pilot study to calculate the power and sample size requirements for larger clinical trial.  
With N=24, the 80% UCL of s is 1.16*s.4  This estimate is relatively precise, resulting in only a 16% 
increase in s, and practical in that the required sample can be obtained from a single site within two years. 
Summaries of demographic and medical characteristics of the patients who agree to participate will be 
calculated for each treatment group.  Continuous variables will be summarized using means, standard 
deviations, medians and ranges.  Counts and percentages will be used to summarize categorical 
measures. 
Primary Analysis: The primary outcome of the study is visual recovery as measured by change in logMAR 
scores from baseline to approximately16-days post-treatment.  As stated above, the primary goal of this 
pilot study is to estimate the sample variance of the temporal changes in these logMAR scores; however, 
we also intend to perform statistical testing.  A two-sample t-test will be used to compare the treatment 
arms with respect to this outcome and a two-tailed 5% α-level will be used to determine statistical 
significance.  Prior to the analysis, the assumption of the t-test procedure will be assessed.  If violated, 
alternative nonparametric testing procedures, such as a Wilcoxon rank sum test, will be employed.  With 
N=24, the t-test described above will have 80% power to detect standardized differences in group means 
of 1.20 standard deviations or larger, or 90% to detect differences of 1.39 standard deviations or larger 
Secondary Analyses: As above, two-sample t-tests will be used to compare the treatment arms with 
respect to ASOCT measures and VAS pain scores.  Log-likelihood ratio tests will be used to compare the 
groups with respect to dichotomous outcomes, such as re-epithelialization at approximately16-days or the 
need for further interventions or surgeries. A 1% α-level will be used to determine statistical significance for 
all secondary analyses. 
 
 
Ethical Considerations 
 
This pilot study will be conducted in accordance with all applicable government regulations and University 
of Arkansas for Medical Sciences research policies and procedures.  This protocol and any amendments 
will be submitted and approved by the UAMS Institutional Review Board (IRB) to conduct the study.   
The formal consent of each subject, using the IRB-approved consent form, will be obtained before that 
subject is submitted to any study procedure.  All subjects for this study will be provided a consent form 
describing this study and providing sufficient information in language suitable for subjects to make an 
informed decision about their participation in this study.  The person obtaining consent will thoroughly 
explain each element of the document and outline the risks and benefits, alternate treatment(s), and 
requirements of the study.  The consent process will take place in a quiet and private room, and subjects 
may take as much time as needed to make a decision about their participation.  Participation privacy will be 
maintained and questions regarding participation will be answered.  No coercion or undue influence will be 
used in the consent process.  This consent form must be signed by the subject or legally authorized 
representative, and the person obtaining the consent.  A copy of the signed consent will be given to the 
participant, and the informed consent process will be documented in the research record.   
 

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                                                           in the Management of Bacterial Corneal Ulcers  
PI: Dr. David Warner 
 
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Dissemination of Data 
 
The study will be listed on clinicaltrials.gov in accordance with FDA requirements. Results of this study may 
be used for presentations, posters, or publications. The publications will not contain any identifiable 
information that could be linked to a participant.   
 
References 
1. Gangopadhyay N, Daniell M, Weih L, et al. Fluoroquinolone and fortified antibiotics for treating 
bacterial corneal ulcers. Br J Ophthalmol. 2000; 84:378-384. 
2. Sheha, H., Liang, L., Li, J., & Tseng, S. C. (2009). Sutureless amniotic membrane transplantation for 
severe bacterial keratitis. Cornea, 28(10), 1118–1123.  
3. Sheha H, Liang L, Li J, Tseng SC. Sutureless amniotic membrane transplantation for severe 
bacterial keratitis. Cornea. 2009;28(10):1118-1123. 
4. Whitehead, A. L., Julious, S. A., Cooper, C. L., & Campbell, M. J. (2016). Estimating the sample size 
for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main 
trial for a continuous outcome variable. Statistical methods in medical research, 25(3), 1057–1073.  
 
Appendices  
 
 
 
 
 
 
 
 
 
 
 
 
 
Supplemental Eye Symptom Questionnaire 
Please circle below which eye was treated: 
 
RIGHT EYE  
LEFT EYE  
 
 
1. In general, would you say your overall health is: 
 
o Excellent 
o Very Good 

A Prospective, Randomized, Controlled Pilot Clinical Study to Evaluate the Use of ProKera Plus®  
                                                           in the Management of Bacterial Corneal Ulcers  
PI: Dr. David Warner 
 
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o Good 
o Fair 
o Poor 
 
2. At the present time, would you say your eyesight using the affected eye (with glasses or contact 
lenses, if you wear them) is: 
 
o Excellent 
o Good 
o Fair 
o Poor 
o Very poor 
 
3. In the last month, how much of your eyesight in the affected eye has improved if at all?  
 
o None 
o Very little  
o A noticeable but not significant amount 
o A lot  
 
4. In the last month, how much pain or discomfort have you had in & around the affected eye (ex: 
burning, itching, or aching)?  
 
 
 
 
 
 
o None 
o Mild 
o Moderate  
o Severe 
o Very Severe  
 
5. If you answered at least Mild in the previous question, how often did you have the 
pain/discomfort?  
 
o Not Applicable 
o Rarely 
o Sometimes 
o Often 
 
6.  In the last month, how much of a problem did you have with burning or stinging in the affected 
eye?  
 
o No problem at all 
o A little bit of a problem 

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                                                           in the Management of Bacterial Corneal Ulcers  
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o Somewhat of a problem 
o Very much of a problem 
 
 
7. In the last month, how much of a problem did you have with the affected eye feeling gritty? 
 
o No problem at all 
o A little bit of a problem 
o Somewhat of a problem 
o Very much of a problem 
 
 
 
 
 
 
7.  In the last month, how much of a problem did you have with the eye being sensitive to light? 
 
o No problem at all 
o A little bit of a problem 
o Somewhat of a problem 
o Very much of a problem 
 
8.  In general, do you currently use contact lenses in either eye? 
 
o No 
o Yes 
 
 
9. Do you have any other concerns regarding your affected eye? Please fill in the blank space 
below: 
 
__________________________________________________________________ 
 
__________________________________________________________________ 
 
__________________________________________________________________ 
 
 
Thank you for taking this survey! 
 

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Date:  09/21/2020  
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