CEQUA for Sjogren's Syndrome Dry Eye

Phase 4

Completed

• Conditions: Dry Eye Syndromes; Sjogren's Syndrome; Dry Eye
• Interventions: Drug: Cyclosporine 0.09% Ophthalmic Solution

• Registration Number: NCT04835623
• Lead Sponsor: Center for Ophthalmic and Vision Research, LLC

Brief 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.

Study Timeline

• Study First Submitted: 2021-04-05
• Study First Submitted QC: 2021-04-06
• Study First Posted: 2021-04-08
• Study Start: 2021-06-21
• Primary Completion: 2024-03-21
• Study Completion: 2024-03-21
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in total corneal staining	Baseline and week 12	Expanded NEI corneal staining scale ranging from 0 to 15

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline in total conjunctival staining	Baseline and week 12	Expanded NEI conjunctival staining scale ranging from 0 to 20
Mean change from baseline in the score of dry eye questionnaires	Baseline and week 12	Dry eye questionnaire score ranging from 0 to 28

Trial Locations

Locations (1)

Center for Ophthalmic and Vision Recearch; 🇺🇸 Manhattan, New York, United States