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Tivanisiran sodium ophthalmic solution for Dry Eye Syndrome

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
FYDES Investigative Site, El Paso, TXDry Eye SyndromeTivanisiran sodium ophthalmic solution - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the safety of tivanisiran sodium eye drops to a placebo in people with dry eye disease, dosed once daily for a year.

Eligible Conditions
  • Dry Eye Syndrome

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

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Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 1 year

1 year
Frequency and percentage of subjects with ocular and non-ocular treatment emergent adverse events (TEAEs) for 1 year

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

2
Aerobic walking
2
Binimetinib
1
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Trial Design

2 Treatment Groups

Tivanisiran sodium ophthalmic solution
1 of 2
Vehicle ophthalmic solution
1 of 2

Experimental Treatment

Non-Treatment Group

301 Total Participants · 2 Treatment Groups

Primary Treatment: Tivanisiran sodium ophthalmic solution · Has Placebo Group · Phase 3

Tivanisiran sodium ophthalmic solution
Drug
Experimental Group · 1 Intervention: Tivanisiran sodium ophthalmic solution · Intervention Types: Drug
Vehicle ophthalmic solution
Drug
PlaceboComparator Group · 1 Intervention: Vehicle ophthalmic solution · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

Sylentis, S.A.Lead Sponsor
11 Previous Clinical Trials
1,136 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have not used artificial tears, autologous serum, or certain dry eye medications within the past 6 months.

Who else is applying?

What state do they live in?
Georgia100.0%
What site did they apply to?
Sylentis Investigative Site100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
Why did patients apply to this trial?
  • "I use muro 128 every night for my dry eyes"
How many prior treatments have patients received?
0100.0%
References

Frequently Asked Questions

Where are patients able to participate in this trial?

"There are 24 sites currently running this clinical trial, which are based in Washington, Largo and Asheville as well as 21 other locations. If you enroll in the trial, it would be most convenient to select the site nearest to your location to minimize travel requirements." - Anonymous Online Contributor

Unverified Answer

Are people still able to sign-up for this experiment?

"According to the listing on clinicaltrials.gov, this particular trial is not currently seeking patients for participation. This study was originally posted on March 24th, 2022 but has since stopped recruiting candidates. However, there are still many other trials (144 in total) that are open for enrollment." - Anonymous Online Contributor

Unverified Answer

When did Tivanisiran sodium ophthalmic solution receive FDA clearance?

"Tivanisiran sodium ophthalmic solution is in Phase 3 trials, meaning that while there is some data supporting efficacy, multiple rounds of data are needed to support safety." - 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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