CEQUA for Sjogren's Syndrome Dry Eye

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-21

Study Completion Date

2024-03-21

Brief Summary

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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.

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Detailed Description

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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

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Dry Eye Dry Eye Syndromes Sjogren's Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cyclosporine

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

Group Type EXPERIMENTAL

Cyclosporine 0.09% Ophthalmic Solution

Intervention Type DRUG

one drop each eye twice daily

Interventions

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Cyclosporine 0.09% Ophthalmic Solution

one drop each eye twice daily

Intervention Type DRUG

Other Intervention Names

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Cequa Ophthalmic Product

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No