CEQUA for Sjogren's Syndrome Dry Eye

Center for Ophthalmic and Vision Research, LLC

Status and phase: Completed; Phase 4

Conditions: Sjogren's Syndrome; Dry Eye; Dry Eye Syndromes

Treatments: Drug: Cyclosporine 0.09% Ophthalmic Solution

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04835623

SP-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Cyclosporine

Experimental group

Description:

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

Treatment:

Drug: Cyclosporine 0.09% Ophthalmic Solution