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CEQUA for Sjogren's Syndrome Dry Eye | Clinical Trials | Clareo Health

COMPLETEDPHASE4

CEQUA for Sjogren's Syndrome Dry Eye

Effects of CEQUA™ on Objective and Subjective Dry Eye Findings Associated With Sjogren's Syndrome

NCT04835623•Center for Ophthalmic and Vision Research, LLC

Summary

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 patients with Sjogren's Syndrome diagnosis.

Detailed Description

After being informed about the study and potential risks, all participants giving informed consent will have an eye exam and will be asked about their medical history to determine eligibility for the study. Eligible participants will continue to the second visit the same day or up to 10 days later. During the second visit participants will answer questionnaires about their eyes and have their vision, eyes, and tears examined. All participants will be given CEQUA to use over the duration of the study. The same procedures will be repeated every four weeks for 3 months total.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Clinical diagnosis of Sjogren's Syndrome.
•Self-reported complaints of ocular dryness for a period of at least 3 months
•Best-corrected distance visual acuity of 20/25 or better in each eye.

Exclusion Criteria

•Use of cyclosporine within the last 3 months.
•Use of ocular steroid within the 3 months.
•Previous history of treatment failure with cyclosporine.
•Known hypersensitivity or contraindication to the study medication or any of its ingredients.
•Use of any systemic or topical ocular medication that is known to cause or exacerbate dry eye.
•Any active ocular infection.
•Severe or serious ocular condition in either eye or any other unstable medical condition that may preclude study treatment or follow-up.
•History or presence of chronic generalized systemic disease that might increase the risk to the subject or confound the results of the study.
•Currently pregnant or lactating.

Locations (1)

Center for Ophthalmic and Vision Recearch

Manhattan, New York, United States

Key Dates

Start Date

June 21, 2021

Primary Completion Date

March 21, 2024

Completion Date

March 21, 2024

Last Updated

April 16, 2024

Enrollment

ACTUAL participants

Conditions

Dry EyeDry Eye SyndromesSjogren's Syndrome

Interventions

Cyclosporine 0.09% Ophthalmic Solution

DRUG

A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study

NCT07463950

Dry Eye Disease (DED)

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RECRUITINGPHASE1

A Clinical Study of TI-0032-III Injection in Patients With Relapsed and Refractory Autoimmune Diseases

NCT07413341

Systemic Lupus Erythematosus (SLE)Sjogren's Syndrome (SS)+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 16, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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CEQUA for Sjogren's Syndrome Dry Eye

Inclusion Criteria

Exclusion Criteria

A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study

A Clinical Study of TI-0032-III Injection in Patients With Relapsed and Refractory Autoimmune Diseases

Rheumatology Patient Registry and Biorepository

A Study on the Correlation Between Tear Iron Levels and the Severity of Dry Eye Disease.

Supplementary Kelulut Honey Therapy in Juvenile Open-Angle Glaucoma: Effects on IL-6, RNFL and Dry Eye

Preliminary Clinical Study of the Effectiveness and Safety of Ocular Surface Microbiota Transplantation in the Treatment of Dry Eye Disease