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Study Summary
This trial will test whether K-161 ophthalmic solution is effective and safe for treating moderate to severe dry eye disease.
- Dry Eye Syndrome
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 2 trial • 238 Patients • NCT04084483Awards & Highlights
Trial Design
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Who is running the clinical trial?
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- You have a history of dry eyes in both eyes and have used eye drops for this condition.You have dry eye disease in both eyes and have used eye drops to treat it.
- Group 1: K-161
- Group 2: Placebo
- 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
What are some of the risks associated with taking K-161?
"K-161 is safe according to our estimation because it has reached Phase 3 in clinical trials. This means that, not only is there data supporting its efficacy, but also that multiple rounds of testing have been conducted to support its safety."
Can people with the necessary conditions enroll in this trial currently?
"That is right, the clinical trial is currently recruiting patients. The first posting was on June 1st, 2022 and there have been no changes since May 31st, 2022. They are looking to enroll 620 people from a single site."
How many volunteers are enrolled in this clinical trial?
"That is correct, the listing on clinicaltrials.gov verifies that this research project is looking for volunteers right now. This specific trial was first announced on 6/1/2022 and has been updated as recently as 5/31/2022. A total of 620 individuals are needed from 1 different locations."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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