CEQUA for Sjogren's Syndrome Dry Eye

Overseen By George Zikos, OD, MS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Center for Ophthalmic and Vision Research, LLC

Must not be taking: Cyclosporine, Ocular steroids

Disqualifiers: Ocular infection, Severe ocular condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

50 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial requires that you have not used cyclosporine or ocular steroids in the last 3 months, and you cannot use any medication that might worsen dry eye. If you're on such medications, you may need to stop them before joining the trial.

What data supports the effectiveness of the drug Cyclosporine 0.09% Ophthalmic Solution for treating dry eye in Sjogren's Syndrome?

Research shows that lower concentrations of cyclosporine, like 0.05%, have been effective in treating dry eye in patients with Sjogren's Syndrome, suggesting that the 0.09% solution may also be beneficial. ^{1 2 3 4 5}

Is CEQUA (Cyclosporine 0.09% Ophthalmic Solution) safe for humans?

CEQUA (Cyclosporine 0.09% Ophthalmic Solution) has been approved by the US Food and Drug Administration for managing dry eye, and numerous clinical trials have assessed its safety. While there is no universal agreement on its effects, it has been widely used and considered safe for treating dry eye conditions. ^{1 2 6 7 8}

How is the drug CEQUA (Cyclosporine 0.09% Ophthalmic Solution) different from other treatments for Sjogren's Syndrome dry eye?

CEQUA is unique because it uses a higher concentration of cyclosporine (0.09%) compared to other formulations like 0.05% or 0.1%, potentially offering a stronger anti-inflammatory effect for treating dry eye in Sjogren's Syndrome. It is specifically designed to increase tear production and reduce inflammation in the eyes. ^{1 3 5 9 10}

What is the purpose of this trial?

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.

Research Team

John Rocco Robilotto, OD, PhD

Principal Investigator

Center for Ophthalmic and Vision Research

Eligibility Criteria

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.

Inclusion Criteria

Within a commutable distance of Manhattan, NY

You have been diagnosed with Sjogren's Syndrome.

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

Exclusion Criteria

Use of ocular steroid within the 3 months.

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

You are pregnant, lactating, or planning to become pregnant in the next 3-4 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 10 days

1 visit (in-person)

Treatment

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

12 weeks

4 visits (in-person, every 4 weeks)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cyclosporine 0.09% Ophthalmic Solution

Trial Overview 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.

Participant Groups

Group I: Cyclosporine Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Center for Ophthalmic and Vision Research, LLC

Lead Sponsor

Trials

2

Recruited

130+

Sun Pharmaceutical Industries Limited

Industry Sponsor

Trials

71

Recruited

14,000+

Dilip Shanghvi

Sun Pharmaceutical Industries Limited

Chief Executive Officer since 1993

Majored in Cellular and Molecular Biology at the University of Michigan – Ann Arbor

Dr. Azadar H. Khan

Sun Pharmaceutical Industries Limited

Chief Medical Officer since 2023

MD from a recognized institution

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Topical cyclosporine a (0.05%) treatment in dry eye patients: a comparison study of Sjogren's syndrome versus non-Sjogren's syndrome. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Evaluation of the Efficacy and Safety of Topical 0.05% Cyclosporine Eye Drops (II) in the Treatment of Dry Eye Associated with Primary Sjögren's Syndrome. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of 0.1% ciclosporin A cationic emulsion in dry eye disease: a pooled analysis of two double-masked, randomised, vehicle-controlled phase III clinical studies. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the effect of topical tacrolimus 0.03% versus cyclosporine 0.05% in the treatment of dry eye secondary to Sjogren syndrome. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Three percent diquafosol ophthalmic solution as an additional therapy to existing artificial tears with steroids for dry-eye patients with Sjögren's syndrome. [2018]

6. India pubmed.ncbi.nlm.nih.gov

Efficacy and safety of topical cyclosporine 0.1% in moderate-to-severe dry eye disease refractory to topical cyclosporine 0.05% regimen. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Topical cyclosporine A therapy for dry eye syndrome. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Topical ocular 0.1% cyclosporine A cationic emulsion in dry eye disease patients with severe keratitis: experience through the French early-access program. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

The Efficacy of Diquafosol Ophthalmic Solution in Non-Sjögren and Sjögren Syndrome Dry Eye Patients Unresponsive to Artificial Tear. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Treatment of Sjögren's syndrome dry eye using 0.03% tacrolimus eye drop: Prospective double-blind randomized study. [2015]