CEQUA for Sjogren's Syndrome Dry Eye

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Center for Ophthalmic and Vision Research, LLC
• Collaborator: Sun Pharma Global FZE
• Treatments: Cyclosporine; Cyclosporins; Ophthalmic Solutions

Criteria

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.