What side effects are associated with this type of intervention?

Common treatments for Dry Eye Syndrome include topical corticosteroids, cyclosporine, and preservative-free artificial tears. Topical corticosteroids, such as fluorometholone and loteprednol, can cause increased intraocular pressure and cataract formation with prolonged use. Cyclosporine drops may cause stinging and eyelid maceration. Preservative-free artificial tears generally have fewer side effects but can still cause irritation in some patients. These treatments aim to reduce inflammation and improve tear production, similar to the investigational Tivanisiran Sodium Eye Drops.

What prior FDA approvals exist?

The FDA has approved several treatments for Dry Eye Syndrome that focus on reducing inflammation and improving tear production. Notable examples include cyclosporine ophthalmic emulsion (Restasis), which reduces inflammation and increases tear production, and lifitegrast ophthalmic solution (Xiidra), which targets the inflammation pathway by inhibiting the binding of lymphocyte function-associated antigen-1 (LFA-1) to intercellular adhesion molecule-1 (ICAM-1). These treatments share a common goal with Tivanisiran Sodium Eye Drops, which aim to reduce pain and inflammation by targeting TRPV1.

What other types of research exist?

Promising novel alternatives to Tivanisiran Sodium Eye Drops for Dry Eye Syndrome in 2024 include: 1. Lifitegrast (Xiidra) - an LFA-1 antagonist that reduces inflammation by inhibiting T-cell activation. 2. Cyclosporine A (Cequa) - an immunomodulator that increases tear production and reduces inflammation. 3. Eysuvis (loteprednol etabonate) - a corticosteroid for short-term treatment of dry eye symptoms. 4. NOV03 (perfluorohexyloctane) - a novel treatment targeting evaporative dry eye by stabilizing the lipid layer of the tear film.

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RNA Interference

Tivanisiran for Dry Eye in Sjögren's Syndrome

Phase 3

Waitlist Available

Research Sponsored by Sylentis, S.A.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Any concomitant treatment or prior ocular procedure or surgery, or alteration of the dose of systemic medications at the time of entry into the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 85 days

Awards & highlights

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.

Who is the study for?

This trial is for adults with Sjögren's Syndrome who suffer from dry eye disease. Participants must have a certain level of dry eye symptoms and not use artificial tears or other specific medications during the study. They can't join if they've had recent eye procedures, surgeries, significant eye diseases, or changes in systemic medication doses.Check my eligibility

What is being tested?

The study tests tivanisiran sodium ophthalmic solution against a placebo (vehicle ophthalmic solution) to see if it's effective and safe when used daily for three months by people with dry eyes due to Sjögren's Syndrome.See study design

What are the potential side effects?

Potential side effects are not detailed here but may include typical reactions associated with ophthalmic solutions such as irritation, redness, discomfort, or allergic reactions at the site of application.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I haven't had recent eye surgery or changed my medication doses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 85 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~85 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 85 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in Corneal Fluorescein Staining (CFS) scale [0-3]. Higher scores mean disease worsening.

Change from baseline in Dry Eye Symptom scale [0-100]. Higher scores mean disease worsening.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Tivanisiran sodium ophthalmic solutionActive Control1 Intervention

Group II: Vehicle ophthalmic solutionPlacebo Group1 Intervention

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Dry Eye Syndrome (DES) treatments often target the underlying causes of tear film instability and inflammation. Tivanisiran Sodium Eye Drops, which use siRNA to target TRPV1, aim to reduce pain and inflammation by silencing specific genes involved in these processes. This is crucial for DES patients as it directly addresses the discomfort and inflammatory responses that exacerbate the condition. Other common treatments include artificial tears to lubricate the eyes, anti-inflammatory medications like cyclosporine to reduce ocular surface inflammation, and punctal plugs to retain natural tears. Understanding these mechanisms helps patients and doctors choose the most effective treatment based on the specific pathophysiology of their DES.

Stimulation of tear secretion by topical agents that increase cyclic nucleotide levels.TRPV4 is activated by mechanical stimulation to induce prostaglandins release in trabecular meshwork, lowering intraocular pressure.Newer advances in medical management of glaucoma.