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Oxervate for Dry Eye Syndrome (NGF0221 Trial)
NGF0221 Trial Summary
This trial will test if the drug cenegermin can help improve symptoms of dry eye disease in patients who are already using the drug cyclosporine A.
- Dry Eye Syndrome
NGF0221 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowNGF0221 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.NGF0221 Trial Design
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Who is running the clinical trial?
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- You have been diagnosed with Sjogren syndrome or another autoimmune disease that can cause dry eye disease.You have struggled with drug addiction or excessive alcohol use in the past year.You are a female with childbearing potential.You have severe Sjogren's dry eye disease, as determined by a questionnaire that measures your dry eye symptoms.You have had cancer in the past 5 years.You have a history of serious allergies that affect your whole body or allergies specifically related to your eyes, except for dry eye.You are female or male aged ≥ 18 years.The participant had a best corrected distance visual acuity of at least 20/200 in each eye at the time of study enrolment.
- Group 1: Oxervate
- Group 2: Vehicle
- 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
Are there any other instances where Oxervate was trialed as a potential treatment?
"Currently, there are 2 active clinical trials researching Oxervate. Of those 2 trials, both are in Phase 3. Most of the studies are located in Garden City, New york; however, there are 23 research centres spread out across the globe."
How can interested individuals sign up for this clinical trial?
"This study, which was posted on clinicaltrials.gov on 1/27/2022, is currently looking for participants."
Does this experiment pave the way for others like it?
"There are currently 2 clinical trials being conducted in 10 cities across 2 nations. The first trial for Oxervate was in 2022 and it completed Phase 3 drug approval in that same year. The trial was sponsored by Dompé Farmaceutici S.p.A and had 104 participants. A total of 221 trials have been completed since then."
Are there any known side effects to using Oxervate?
"We believe that Oxervate is reasonably safe, as it is a Phase 3 trial medication. This suggests that there is some evidence of its efficacy, as well as multiple rounds of data supporting its safety."
In how many different locations is this trial taking place today?
"There are 6 sites enrolling patients, such as The Johns Hopkins University in Baltimore, Eye Consultants of Atlanta in Atlanta, TUSM - New England Eye Center/Tufts Medical Center in Boston, as well as 6 other locations."
How many test subjects are participating in this trial?
"That is correct, the information available on clinicaltrials.gov does show that this particular clinical trial is looking for participants. The trial was first posted on 1/27/2022, and the most recent update was on 10/24/2022. They are looking to have a total of 80 participants at 6 different locations."
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