What side effects are associated with this type of intervention?

Common treatments for Sjogren's Syndrome, particularly those similar to CEQUA (Cyclosporine 0.09% Ophthalmic Solution), often include topical cyclosporine and other immunosuppressive agents. The most frequently reported side effects of topical cyclosporine include mild to moderate instillation site pain, burning sensation, and eye redness. Systemic treatments, such as oral cyclosporine, may cause more severe side effects like nephrotoxicity, hypertension, and increased risk of infections. Other topical treatments, like corticosteroids, can lead to increased intraocular pressure and cataract formation with prolonged use.

What prior FDA approvals exist?

The FDA has approved several treatments for Sjogren's Syndrome, particularly for managing dry eye symptoms. CEQUA (Cyclosporine 0.09% Ophthalmic Solution) is one such treatment that inhibits T-cell activation and reduces inflammation to improve tear production. Another similar drug is Restasis (Cyclosporine 0.05% Ophthalmic Emulsion), which also targets T-cell activation to increase tear production. Additionally, Xiidra (Lifitegrast Ophthalmic Solution) is approved for dry eye disease and works by inhibiting the binding of certain proteins that contribute to inflammation. These treatments focus on reducing inflammation and improving tear production to alleviate the symptoms of dry eye associated with Sjogren's Syndrome.

What other types of research exist?

Promising alternatives to CEQUA for Sjogren's Syndrome patients include: <ol> <li>Rebamipide 2% ophthalmic suspension, which has shown efficacy in improving signs and symptoms of keratoconjunctivitis sicca in Sjogren's Syndrome patients.</li> <li></li> </ol> Tacrolimus ointment, which has been effective for refractory posterior blepharitis. 3. Systemic immunomodulatory agents like methotrexate, cyclosporine A, and infliximab, which have been used to control inflammation in severe dry eye cases secondary to inflammation.

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Immunosuppressant

CEQUA for Sjogren's Syndrome Dry Eye

Phase 4

Waitlist Available

Led By John Rocco Robilotto, OD, PhD

Research Sponsored by Center for Ophthalmic and Vision Research, LLC

Eligibility Criteria Checklist

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

Must have

Self-reported complaints of ocular dryness for a period of at least 3 months

Clinical diagnosis of Sjogren's Syndrome.

Must not have

Use of ocular steroid within the 3 months.

Previous history of treatment failure with cyclosporine.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and week 12

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing eye drops to see if they help people with Sjogren's Syndrome who have very dry eyes. The drops work by reducing swelling in the eyes and helping them make more tears.

Who is the study for?

This trial is for individuals with Sjogren's Syndrome who have been experiencing dry eyes for at least three months and can travel to Manhattan, NY. It's not suitable for those who've used eye steroids recently, had no success with cyclosporine before, or are pregnant or planning pregnancy soon.

What is being tested?

The study aims to determine if CEQUA (cyclosporine 0.09% ophthalmic solution) can relieve the symptoms of dry eye disease in patients diagnosed with Sjogren's Syndrome.

What are the potential side effects?

Potential side effects may include a burning sensation in the eyes, eye redness, discharge, pain, itching or stinging; however individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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You have experienced dry eyes for at least three months and have reported it yourself.

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You have been diagnosed with Sjogren's Syndrome.

Exclusion Criteria

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

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You have tried cyclosporine before and it didn't work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Staining method

Secondary study objectives

Mean change from baseline in the score of dry eye questionnaires

Mean change from baseline in total conjunctival staining

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: CyclosporineExperimental Treatment1 Intervention

Participants receive Cyclosporine 0.09% Ophthalmic Solution (Cequa), 1 drop, each eye, twice a day for 12 weeks

0 / 6Eligibility 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

Common treatments for Sjogren's Syndrome, such as CEQUA (Cyclosporine 0.09% Ophthalmic Solution), work by inhibiting T-cell activation and reducing inflammation. This is crucial for patients because Sjogren's Syndrome is characterized by an autoimmune response that targets moisture-producing glands, leading to symptoms like dry eyes and mouth. By reducing inflammation and preventing T-cells from attacking these glands, these treatments help improve tear production and alleviate dry eye symptoms, significantly enhancing the quality of life for patients.

Systemic immunomodulatory therapy in severe dry eye secondary to inflammation.