CEQUA for Sjogren's Syndrome Dry Eye

Sponsor

Center for Ophthalmic and Vision Research, LLC (Other)

Overall Status

Recruiting

CT.gov ID

NCT04835623

Collaborator

Sun Pharmaceutical Industries Limited (Industry)

Enrollment

Location

Arm

23.3

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Dry Eye Syndromes Sjogren's Syndrome	Drug: Cyclosporine 0.09% Ophthalmic Solution	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 21, 2021

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cyclosporine Participants receive Cyclosporine 0.09% Ophthalmic Solution (Cequa), 1 drop, each eye, twice a day for 12 weeks	Drug: Cyclosporine 0.09% Ophthalmic Solution one drop each eye twice daily Other Names: Cequa Ophthalmic Product

Arm

Intervention/Treatment

Experimental: Cyclosporine

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

Drug: Cyclosporine 0.09% Ophthalmic Solution

one drop each eye twice daily

Other Names:

Cequa Ophthalmic Product

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.