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Tivanisiran for Dry Eye in Sjögren's Syndrome
Study Summary
This trial will compare the effectiveness and safety of tivanisiran sodium eye drops to artificial tears (vehicle) in people with dry eye disease caused by Sjögren's Syndrome, after a 2-week run-in phase.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am 18 years old or older.I haven't had recent eye surgery or changed my medication doses.You cannot wear contact lenses during the study.You have eye problems that the researcher considers significant.I have used artificial tears or specific dry eye treatments in the last 6 months.You agree not to use AT or autologous serum during the study.You have Sjögren Syndrome.
- Group 1: Vehicle ophthalmic solution
- Group 2: Tivanisiran sodium ophthalmic solution
- 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 participating hospitals in Canada?
"There are a total of 34 sites running this study at the moment, with centres in locations such as Birmingham, Largo and Saint Louis. If you are considering participating, be sure to choose a location near you to limit travel."
Has Tivanisiran's ophthalmic solution received FDA approval?
"Tivanisiran sodium ophthalmic solution is considered safe based on Phase 3 trial data. This means that the medication has shown some efficacy in prior trials and has undergone multiple rounds of testing to support its safety."
Is there still room for more people in this trial?
"The clinical trial is still open and actively recruiting patients, as of 9/15/2022. This can be seen on clinicaltrials.gov, where the study was first posted on 5/25/2021. In total, the clinical trial needs 200 participants, which 34 different locations across the country."
How many volunteers are currently enrolling in this research project?
"That is correct. The information displayed on clinicaltrials.gov reveals that this study is still recruiting patients. This specific trial was first posted on May 25th, 2021 and was edited most recently on September 15th, 2022. In total, the study needs 200 participants from 34 different locations."
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