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Rose Bengal + Light Therapy for Corneal Inflammation (REAGIR Trial)
REAGIR Trial Summary
This trial will compare two treatments for corneal ulcers: one standard medical treatment plus a new treatment using light therapy.
REAGIR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowREAGIR Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.REAGIR Trial Design
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Who is running the clinical trial?
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- I am at risk of or currently have a ruptured organ.I have not had eye surgery in the last three months.I have had a corneal transplant.My eye condition involves the sclera.I am not able to make decisions or think clearly due to my condition.I am over 18 years old.I have keratitis not caused by an infection or autoimmune disease.My vision is 20/40 or worse.My vision is 20/40 or worse.
- Group 1: Cross-Linking with rose Bengal (RB-PDT)
- Group 2: Standard Therapy
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the Federal Drug Administration signed off on Rose Bengal?
"There is some efficacy data and multiple safety rounds supporting Phase 3 trials, which gives Rose Bengal a score of 3 for safety."
What are some past examples of research using Rose Bengal?
"There are a total of 49 ongoing clinical trials researching Rose Bengal. Of these, 16 have reached Phase 3. The majority of these live studies for Rose Bengal are based in Redwood City, California; however, there are 586 locations running these sorts of investigations worldwide."
How many individuals are included in the testing for this new medication?
"This trial is no longer recruiting patients. The listing for this particular study was first posted on June 1st, 2022 and the most recent update was on May 31st, 2022. 20 other trials are currently looking for patients with acanthamoeba keratitis while 49 studies are searching for individuals to participate who have been diagnosed with Rose Bengal."
What is Rose Bengal's typical application?
"Rose Bengal is a medication with multiple functions. It can be used to treat community acquired pneumonia, wound infections, and topical antisepsis."
To your knowledge, is this the inaugural clinical trial of its type?
"As of now, there are 49 ongoing medical trials that use Rose Bengal as part of the treatment. These studies are taking place in 260 cities and 48 nations. The first time this compound was used in a trial was back in 2009. 78 individuals participated in the Phase 1 study which Provectus Biopharmaceuticals, Inc. sponsored. In total, since 2009, 18735 separate trials have been completed that utilize rose bengal in some capacity."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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