Trial Outcomes & Findings for Evaluating the Use of ProKera Plus® in the Management of Bacterial Corneal Ulcers (NCT NCT04850313)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

5-day Follow-Up, plus or minus 3 days

Results posted on

2023-07-07

Participant Flow

Total number of candidates screened and enrolled in study was 3. The goal of the study was to enroll 24 subjects, 12 subjects per group. Patients were recruited in the medical clinic (UAMS). recruitment started in November 2021 and ended in March 2022.

After at least 48 hours of conventional treatment, consent will be obtained regarding the use of experimental treatment with Prokera Plus versus continuing conventional treatment. This will be randomized in a 1:1 ratio by a block-randomization schedule to assign subjects to each of the two treatment groups. All three subjects that were screened were consented and assigned a group.

Participant milestones

Participant milestones
Measure	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	ProKera Plus® Treatment 1\. Experimental Treatment Arm , ProKera Plus® will be placed in the eye with the corneal ulcer 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.
Overall Study STARTED	1	2
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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	ProKera Plus® Treatment 1\. Experimental Treatment Arm , ProKera Plus® will be placed in the eye with the corneal ulcer 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.
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Conventional Treatment n=1 Participants * 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 n=2 Participants 1\. Experimental Treatment Arm , ProKera Plus® will be placed in the eye with the corneal ulcer 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.	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=1 Participants	0 Participants n=2 Participants	0 Participants n=3 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=1 Participants	2 Participants n=2 Participants	3 Participants n=3 Participants
Age, Categorical >=65 years	0 Participants n=1 Participants	0 Participants n=2 Participants	0 Participants n=3 Participants
Sex: Female, Male Female	1 Participants n=1 Participants	1 Participants n=2 Participants	2 Participants n=3 Participants
Sex: Female, Male Male	0 Participants n=1 Participants	1 Participants n=2 Participants	1 Participants n=3 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Vision Acuity at Baseline	1.9 LogMAR STANDARD_DEVIATION NA • n=1 Participants	1.45 LogMAR STANDARD_DEVIATION .45 • n=2 Participants	1.6 LogMAR STANDARD_DEVIATION .424 • n=3 Participants

PRIMARY outcome

Timeframe: 5-day Follow-Up, plus or minus 3 days

Population: All randomized subjects regardless of actual treatment, with data at the 5-day Follow-up Evaluation.

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.

Outcome measures

Outcome measures
Measure	Conventional Treatment n=1 Participants * 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 n=2 Participants 1\. Experimental Treatment Arm , ProKera Plus® will be placed in the eye with the corneal ulcer 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.
Visual Acuity - Visit 1	1.3 LogMar Standard Deviation NA Standard deviation not available because only one participant is assigned conventional treatment.	3.3 LogMar Standard Deviation .65

PRIMARY outcome

Timeframe: 16-day follow-up plus or minus 5 days

Population: All randomized subjects regardless of actual treatment, with data at the 16-day Follow-up Evaluation.

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.

Outcome measures

Outcome measures
Measure	Conventional Treatment n=1 Participants * 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 n=2 Participants 1\. Experimental Treatment Arm , ProKera Plus® will be placed in the eye with the corneal ulcer 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.
Visual Recovery - Visit 2	1.3 LogMar Standard Deviation NA Standard deviation not available because only one participant is assigned conventional treatment.	2.1 LogMar Standard Deviation 0.2

PRIMARY outcome

Timeframe: 30-day follow-up plus or minus 7 days

Population: All randomized subjects regardless of actual treatment, with data at the 30-day Follow-up Evaluation.

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.

Outcome measures

Outcome measures
Measure	Conventional Treatment n=1 Participants * 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 n=2 Participants 1\. Experimental Treatment Arm , ProKera Plus® will be placed in the eye with the corneal ulcer 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.
Visual Recovery - Visit 3	0.6 LogMar Standard Deviation NA Standard deviation not available because only one participant is assigned conventional treatment.	2.1 LogMar Standard Deviation 0.2

PRIMARY outcome

Timeframe: 90 day follow-up plus or minus 10 days

Population: All randomized subjects regardless of actual treatment, with data at the 90-day Follow-up Evaluation.

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.

Outcome measures

Outcome measures
Measure	Conventional Treatment n=1 Participants * 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 n=1 Participants 1\. Experimental Treatment Arm , ProKera Plus® will be placed in the eye with the corneal ulcer 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.
Visual Recovery - Visit 4	.47 LogMar Standard Deviation NA Standard deviation not available because only one participant is assigned conventional treatment.	.70 LogMar Standard Deviation NA Standard deviation not available because only one participant was seen due to adverse event and was seen in clinic as part of standard of care only (Not study related).

PRIMARY outcome

Timeframe: 180-day follow-up plus or minus 14 days

Population: All randomized subjects regardless of actual treatment, with data at the 180-day Follow-up Evaluation.

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.

Outcome measures

Outcome measures
Measure	Conventional Treatment n=1 Participants * 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 n=1 Participants 1\. Experimental Treatment Arm , ProKera Plus® will be placed in the eye with the corneal ulcer 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.
Visual Recovery - Visit 5	.6 LogMar Standard Deviation NA Standard deviation not available because only one participant is assigned conventional treatment.	1 LogMar Standard Deviation NA Standard deviation not available because only one participant was seen due to adverse event and was seen in clinic as part of standard of care only (Not study related).

SECONDARY outcome

Timeframe: 5-day follow-up plus or minus 3 days

number of participants who had slit lamp photography which measured fluorescein staining size.

Outcome measures

Outcome measures
Measure	Conventional Treatment n=1 Participants * 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 n=2 Participants 1\. Experimental Treatment Arm , ProKera Plus® will be placed in the eye with the corneal ulcer 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.
Corneal Re-epithelialization - Visit 1	0 participants	1 participants

SECONDARY outcome

Timeframe: 16-day follow-up plus or minus 5 days

number of participants who had slit lamp photography which measured fluorescein staining size.

Outcome measures

Outcome measures
Measure	Conventional Treatment n=1 Participants * 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 n=2 Participants 1\. Experimental Treatment Arm , ProKera Plus® will be placed in the eye with the corneal ulcer 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.
Corneal Re-epithelialization - Visit 2	1 participants	2 participants

SECONDARY outcome

Timeframe: 30-day follow-up plus or minus 7 days

number of participants who had slit lamp photography which measured fluorescein staining size.

Outcome measures

Outcome measures
Measure	Conventional Treatment n=1 Participants * 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 n=2 Participants 1\. Experimental Treatment Arm , ProKera Plus® will be placed in the eye with the corneal ulcer 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.
Corneal Re-epithelialization - Visit 3	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 90-day follow-up plus or minus 10 days

number of participants who had slit lamp photography which measured fluorescein staining size.

Outcome measures

Outcome measures
Measure	Conventional Treatment n=1 Participants * 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 n=1 Participants 1\. Experimental Treatment Arm , ProKera Plus® will be placed in the eye with the corneal ulcer 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.
Corneal Re-epithelialization - Visit 4	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 5-day follow-up plus or minus 3 days

number of participants who had anterior segment optical coherence tomography (ASOCT).

Outcome measures

Outcome measures
Measure	Conventional Treatment n=1 Participants * 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 n=2 Participants 1\. Experimental Treatment Arm , ProKera Plus® will be placed in the eye with the corneal ulcer 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.
Corneal Opacity Size - Visit 1	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 30-day follow-up plus or minus 7 days

number of participants who had anterior segment optical coherence tomography (ASOCT).

Outcome measures

Outcome measures
Measure	Conventional Treatment n=1 Participants * 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 n=2 Participants 1\. Experimental Treatment Arm , ProKera Plus® will be placed in the eye with the corneal ulcer 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.
Corneal Opacity Size - Visit 3	0 Participants	2 Participants

SECONDARY outcome

Timeframe: 5-day follow-up plus or minus 3 days

number of participants who had anterior segment optical coherence tomography (ASOCT).

Outcome measures

Outcome measures
Measure	Conventional Treatment n=1 Participants * 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 n=2 Participants 1\. Experimental Treatment Arm , ProKera Plus® will be placed in the eye with the corneal ulcer 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.
Corneal Opacity Thinning-Visit 1	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 30-day follow-up plus or minus 7 days

number of participants who had anterior segment optical coherence tomography (ASOCT).

Outcome measures

Outcome measures
Measure	Conventional Treatment n=1 Participants * 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 n=2 Participants 1\. Experimental Treatment Arm , ProKera Plus® will be placed in the eye with the corneal ulcer 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.
Corneal Opacity Thinning-Visit 3	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 5-day follow-up plus or minus 3 days

Population: All randomized subjects regardless of actual treatment, with data at the 5-day Follow-up Evaluation.