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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether CEQUA, an eye drop containing cyclosporine, can alleviate dry eye symptoms in individuals with Sjogren's Syndrome. Sjogren's Syndrome is an autoimmune condition that frequently causes dry eyes. Participants will apply the eye drops twice daily for 12 weeks. The trial suits those diagnosed with Sjogren's Syndrome who have experienced dry eyes for at least three months and can see clearly with glasses or contacts. As a Phase 4 trial, CEQUA is already FDA-approved and proven effective, and this research aims to understand its benefits for more patients.

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 is the safety track record for this treatment?

Research has shown that CEQUA, an eye drop containing cyclosporine 0.09%, is generally safe for treating dry eyes. Earlier studies identified mild side effects, such as a stinging sensation (experienced by 22% of participants) and eye redness (noticed by 6% of participants). These effects are typically temporary and not serious. The FDA has approved CEQUA for long-term dry eye treatment, indicating its safety. While some individuals might experience these mild side effects, many do not encounter any issues. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Cyclosporine 0.09% Ophthalmic Solution, known as Cequa, is unique because it delivers cyclosporine in a higher concentration than some other treatments for dry eye associated with Sjogren's Syndrome, like Restasis. This higher concentration can potentially lead to more effective treatment outcomes by reducing inflammation more efficiently. Additionally, Cequa uses a novel delivery system, which helps improve the penetration of the medication into the eye, potentially making it more effective than standard options. Researchers are excited about this treatment because it might offer quicker and more noticeable relief for patients suffering from this chronic condition.

What is the effectiveness track record for Cyclosporine 0.09% Ophthalmic Solution in treating dry eye disease in patients with Sjogren's Syndrome?

Research has shown that CEQUA, a cyclosporine 0.09% eye drop, helps people with dry eye disease by boosting tear production. This stronger formula outperforms the more common 0.05% version used for similar issues. Users of CEQUA have reported significant improvements in symptoms, such as increased tear production, with regular use. Results typically appear within 4 to 12 weeks, though individuals with dry eye from Sjogren's Syndrome might notice faster improvements. CEQUA performs comparably to other treatments, such as 0.1% fluorometholone. ^{6 7 8 9 10}

Who Is on the Research Team?

John Rocco Robilotto, OD, PhD

Principal Investigator

Center for Ophthalmic and Vision Research

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04835623?term=Cequa&rank=4

NCT04835623 | CEQUA for Sjogren's Syndrome Dry Eye The primary objective of this study is to show that CEQUA ( cyclosporine 0.09% ophthalmic solution) improves symptoms of dry eye disease in a population of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7518773/

Preclinical Efficacy Comparison of Cyclosporine ... Overall, tear production significantly increased with cyclosporine ophthalmic solution 0.09% twice daily vs cyclosporine ophthalmic emulsion 0.05% twice daily ...

3. withpower.com withpower.com/trial/phase-4-sjogrens-syndrome-5-2021-8bb29

CEQUA for Sjogren's Syndrome Dry Eye · Info for Participants Research shows that lower concentrations of cyclosporine, like 0.05%, have been effective in treating dry eye in patients with Sjogren's Syndrome, suggesting ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9861012/

Management of Sjogren's Dry Eye Disease—Advances in ... Cyclosporine requires consistent dosing and has a delayed onset of 4 to 12 weeks but shows a faster response in SSDE. It is as effective as 0.1% fluorometholone ...

5. cequapro.com cequapro.com/efficacy

Study Results of Patients with Chronic Dry Eye Disease (DED) The primary endpoint for Study 2 was percentage of eyes demonstrating an improvement of ≥10 mm in Schirmer score after 84 days of treatment. Both studies ...

6. cequapro.com cequapro.com/safety

CEQUA® (cyclosporine ophthalmic solution) 0.09% Safety The most common adverse reactions reported in greater than 5% of patients were pain on instillation of drops (22%) and conjunctival hyperemia (6%). Other ...

7. cequa.com cequa.com/safety

CEQUA® for Chronic Dry Eye | Safety CEQUA (cyclosporine ophthalmic solution) 0.09% is a topical solution that helps to increase the production of natural tears in your eye.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04835623?term=AREA%5BBasicSearch%5D(Dry%20eye)&rank=10

NCT04835623 | CEQUA for Sjogren's Syndrome Dry Eye Experimental : Cyclosporine. Participants receive Cyclosporine 0.09% Ophthalmic Solution (Cequa), 1 drop, each eye , twice a day for 12 weeks.

9. eyesoneyecare.com eyesoneyecare.com/resources/cequa-r-is-how-you-and-your-patients-see-eye-to-eye/

CEQUA® Is How You and Your Patients See Eye to Eye Paul Karpecki, OD, FAAO, explains how CEQUA® (cyclosporine ophthalmic solution) 0.09% can increase tear production in patients with dry eye

10. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2018/210913Orig1s000MedR.pdf

Clinical Review(s) - accessdata.fda.gov Established Name cyclosporine ophthalmic solution,. 0.09%. (Proposed) Trade Name Cequa. Therapeutic Class calcineurin inhibitor.