CEQUA for Sjogren's Syndrome Dry Eye

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dry Eye, Dry Eye Syndromes, Sjogren's Syndrome

Intervention / Treatment
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* Drug: Cyclosporine 0.09% Ophthalmic Solution


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cyclosporine<br>Participants receive Cyclosporine 0.09% Ophthalmic Solution (Cequa), 1 drop, each eye, twice a day for 12 weeks | Drug: Cyclosporine 0.09% Ophthalmic Solution<br>* one drop each eye twice daily<br>* Other names: Cequa Ophthalmic Product;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in total corneal staining | Expanded NEI corneal staining scale ranging from 0 to 15 | Baseline and week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in total conjunctival staining | Expanded NEI conjunctival staining scale ranging from 0 to 20 | Baseline and week 12 | 
| Mean change from baseline in the score of dry eye questionnaires | Dry eye questionnaire score ranging from 0 to 28 | Baseline and week 12 |