CEQUA for Sjogren's Syndrome Dry Eye

  • days left to enroll
  • participants needed
  • sponsor
    Center for Ophthalmic and Vision Research, LLC
Updated on 4 October 2022


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.


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.

Condition Dry Eye, Dry Eye Syndromes, Sjogren's Syndrome
Treatment Cyclosporine 0.09% Ophthalmic Solution
Clinical Study IdentifierNCT04835623
SponsorCenter for Ophthalmic and Vision Research, LLC
Last Modified on4 October 2022


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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