NCT04835623

CEQUA for Sjogren's Syndrome Dry Eye

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Center for Ophthalmic and Vision Research, LLC · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dry Eye
• Dry Eye Syndromes
• Sjogren's Syndrome

Interventions

Type	Name	Description
DRUG	Cyclosporine 0.09% Ophthalmic Solution	one drop each eye twice daily

Timeline

• Start date: 2021-06-21
• Primary completion: 2024-03-21
• Completion: 2024-03-21
• First posted: 2021-04-08
• Last updated: 2024-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study