ProProKera Plus® for Corneal Ulcer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Arkansas for Medical Sciences, Little Rock, AR
Corneal Ulcer+2 More
ProProKera Plus® - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

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

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Eligible Conditions

  • Corneal Ulcer
  • Bacterial Corneal Ulcer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Corneal Ulcer

Study Objectives

This trial is evaluating whether ProProKera Plus® will improve 1 primary outcome and 8 secondary outcomes in patients with Corneal Ulcer. Measurement will happen over the course of up to 3 months after initial treatment.

16 days after treatment
Corneal Opacity Thinning (Measured by ASOCT)
Eye Pain (assessed using the VAS ranging from 0 - 10)
Up to 21 days
Corneal Opacity Size (Measured by ASOCT)
Corneal Opacity Thinning
Month 3
Complications/Adverse Events (number of instances where additional procedures are needed)
Up to 37 days
Corneal Re-epithelialization
Month 14
Eye Pain
Visual Recovery
Month 3
Corneal Re-epithelialization (measured by fluorescein staining size on examination using slit lamp photography)

Trial Safety

Safety Progress

1 of 3

Other trials for Corneal Ulcer

Trial Design

2 Treatment Groups

Conventional Treatment
1 of 2
ProKera Plus® Treatment
1 of 2
Active Control
Experimental Treatment

This trial requires 24 total participants across 2 different treatment groups

This trial involves 2 different treatments. ProProKera Plus® is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

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

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 months 14 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 6 months 14 days for reporting.

Closest Location

University of Arkansas for Medical Sciences - Little Rock, AR

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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.

Patient Q&A Section

What causes ulcer?

"The cause of ulceration remains a mystery. Factors like an increased acid load could not be fully ruled out. Some ulcers were still unexplained. Although the mechanism of ulcer formation remains to be determined, the overall increase in acid load in the stomach could result in more acid-related ulcerations in the future." - Anonymous Online Contributor

Unverified Answer

How many people get ulcer a year in the United States?

"Among US adults, 25,066 individuals experience an ulcer (bleeding/disfecation from ulcer) a year, making it the second most common cause of the hospitalization of patients with gastrointestinal symptoms. In all age groups, females are more likely to experience gastrointestinal ulcers than males, with the exception of 55+ year old women. Age-adjusted rates were about 3.4 per 100,000 inhabitants per year among females and 2.4 among males." - Anonymous Online Contributor

Unverified Answer

What are common treatments for ulcer?

"A variety of ulcer treatment options are available. The most effective, durable treatment of choice is wound care with topical ulcer dressing and high-caloric diets." - Anonymous Online Contributor

Unverified Answer

Can ulcer be cured?

"Ulcer is a common problem, and, despite medical intervention, half the patients required major surgical procedures and 3/5 will require ambulatory care to treat this condition." - Anonymous Online Contributor

Unverified Answer

What is ulcer?

"Ulcer seems to be a common disease affecting between one out of ten and one out of five people in the general population of Hong Kong. It commonly affects people during the age group of 40 to 60 years. The disease is most commonly due to injury, or malnutrition or infection resulting from lack of access to health care. Diagnosis of ulcer is generally by clinical observation and the use of specific laboratory tests." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving proprokera plus®?

"Based on the present data, the combination tested was well tolerated in clinical practice, and further studies are warranted to evaluate its efficacy in real-life settings." - Anonymous Online Contributor

Unverified Answer

Does ulcer run in families?

"Findings from a recent study provides no evidence that ulcer is a dominantly inherited disease. Whether ulcer is a multifactorial disease is still a matter of debate." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in proprokera plus® for therapeutic use?

"Since its introduction in 2007, proprokera plus® has been demonstrated to be effective for the improvement of skin roughness, roughness of hair growth and hair strength in subjects with photo-aged and/or dry skin. Proprokera+ plus® is considered one of the top three products that can be purchased online. It is now available through many commercial dealerships worldwide and has also been launched in countries around the world, including Brazil, Germany, Italy, Mexico, the Netherlands, Spain, Serbia and the United States. Its effectiveness is also well supported by the many published clinical studies, which have been carried out on thousands of different subjects." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets ulcer?

"Ulcer incidence was found to be significantly higher in males than in females; however, the incidence was much lower in those with higher levels of education, but greater age and other factors were found to be significant risk factors for the disease in both genders." - Anonymous Online Contributor

Unverified Answer

How serious can ulcer be?

"Ulcer and other gastrointestinal (GI) symptoms had the highest frequency associated with serious complications. Other features that increase risk for serious complications included: diabetes mellitus, smoking, and higher number of previous ulcer episodes. As serious complications in SES increased the mortality rate doubled, while the majority of cases remained in the outpatient setting, for non-life threatening condition." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of proprokera plus®?

"In a recent study, findings, all patients were treated for their severe dry dry skin with Proprokera. The most frequent adverse events included dry skin, dry scalp, and itching." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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