Bacterial Corneal UlcerNCT04850313
Evaluating the Use of ProKera Plus® in the Management of Bacterial Corneal Ulcers
A study testing ProProKera Plus® in people with Bacterial Corneal Ulcer, run by University of Arkansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Corneal Ulcer
- What is being tested?
- ProProKera Plus®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2021to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: 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.
Read the 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
- Conditions
- Bacterial Corneal Ulcer
- Being tested
- ProProKera Plus®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProProKera Plus®Device
Also called ProKera 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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Treatment | No intervention | * 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 |
| ProKera Plus® Treatment | Experimental | 1. Experimental Treatment Arm , ProKera Plus® will be placed in the eye with the corneal ulcer Receives: Device: ProProKera Plus® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5-day Follow-Up, plus or minus 3 days
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.
Measured: 16-day follow-up plus or minus 5 days
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.
Measured: 30-day follow-up plus or minus 7 days
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.
Measured: 90 day follow-up plus or minus 10 days
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.
Measured: 180-day follow-up plus or minus 14 days
Secondary outcomes (13)
Corneal Re-epithelialization - Visit 1
number of participants who had slit lamp photography which measured fluorescein staining size.
Measured: 5-day follow-up plus or minus 3 days
Corneal Re-epithelialization - Visit 2
number of participants who had slit lamp photography which measured fluorescein staining size.
Measured: 16-day follow-up plus or minus 5 days
Corneal Re-epithelialization - Visit 3
number of participants who had slit lamp photography which measured fluorescein staining size.
Measured: 30-day follow-up plus or minus 7 days
Corneal Re-epithelialization - Visit 4
number of participants who had slit lamp photography which measured fluorescein staining size.
Measured: 90-day follow-up plus or minus 10 days
Corneal Opacity Size - Visit 1
number of participants who had anterior segment optical coherence tomography (ASOCT).
Measured: 5-day follow-up plus or minus 3 days
Corneal Opacity Size - Visit 3
number of participants who had anterior segment optical coherence tomography (ASOCT).
Measured: 30-day follow-up plus or minus 7 days
Corneal Opacity Thinning-Visit 1
number of participants who had anterior segment optical coherence tomography (ASOCT).
Measured: 5-day follow-up plus or minus 3 days
Corneal Opacity Thinning-Visit 3
number of participants who had anterior segment optical coherence tomography (ASOCT).
Measured: 30-day follow-up plus or minus 7 days
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)
Measured: 5-day follow-up plus or minus 3 days
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)
Measured: 16-day follow-up plus or minus 5 days
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)
Measured: 30-day follow-up plus or minus 7 days
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)
Measured: 90-day follow-up plus or minus 10 days
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)
Measured: 180-day follow-up plus or minus 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start9 Nov 2021
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Why it stopped: This study terminated due to slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bacterial Corneal UlcerStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Warrner, MD, Principal investigator, University Of Arkansas For Medical Sciences, Jones Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850313
- Sponsor's protocol ID
- 262292
- Status last verified
- Mar 2023
- First submitted
- 7 Apr 2021
- Last updated
- 7 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Clinical Study to Evaluate the Use of ProKera Plus® in the Management of Bacterial Corneal Ulcers
- ClinicalTrials.gov ID
- NCT04850313
- Acronym / sponsor ID
- 262292
- Conditions
- Bacterial Corneal Ulcer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study terminated due to slow enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 20 Apr 2021 (actual)
- Results
- Posted 7 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Conventional Treatment | No intervention | –* 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 |
| ProKera Plus® Treatment | Experimental | Device: ProProKera Plus®1. Experimental Treatment Arm , ProKera Plus® will be placed in the eye with the corneal ulcer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProProKera Plus®Also: ProKera 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. | Device | ProKera Plus® Treatment |
Primary outcome
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.
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.
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.
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.
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.
13 secondary outcomes
Corneal Re-epithelialization - Visit 1
Time frame: 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
Corneal Re-epithelialization - Visit 3
Time frame: 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
Corneal Opacity Size - Visit 1
Time frame: 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
Corneal Opacity Thinning-Visit 1
Time frame: 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
Eye Pain- Visit 1
Time frame: 5-day follow-up plus or minus 3 days
Eye Pain- Visit 2
Time frame: 16-day follow-up plus or minus 5 days
Eye Pain- Visit 3
Time frame: 30-day follow-up plus or minus 7 days
Eye Pain- Visit 4
Time frame: 90-day follow-up plus or minus 10 days
Eye Pain- Visit 5
Time frame: 180-day follow-up plus or minus 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Bacterial Corneal Ulcer
Recruiting
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Bacterial Keratitis, Recalcitrant Infectious Keratitis
Not yet recruitingPhase 2
Fluorometholone Study
Keratitis Bacterial, Corneal Ulcer (Diagnosis)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Warrner, MD principal investigator
University Of Arkansas For Medical Sciences, Jones Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProProKera Plus® in people with Bacterial Corneal Ulcer, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity - Visit 1 (time frame: 5-day Follow-Up, plus or minus 3 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.