CEQUA for Sjogren's Syndrome Dry Eye

Last updated: April 15, 2024
Sponsor: Center for Ophthalmic and Vision Research, LLC
Overall Status: Completed

Phase

4

Condition

Sjogren's Syndrome

Dermatomyositis (Connective Tissue Disease)

Dry Eyes

Treatment

Cyclosporine 0.09% Ophthalmic Solution

Clinical Study ID

NCT04835623
SP-001
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 itsingredients.
  • Use of any systemic or topical ocular medication that is known to cause or exacerbatedry eye.
  • Any active ocular infection.
  • Severe or serious ocular condition in either eye or any other unstable medicalcondition that may preclude study treatment or follow-up.
  • History or presence of chronic generalized systemic disease that might increase therisk to the subject or confound the results of the study.
  • Currently pregnant or lactating.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Cyclosporine 0.09% Ophthalmic Solution
Phase: 4
Study Start date:
June 21, 2021
Estimated Completion Date:
March 21, 2024

Study 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.

Connect with a study center

  • Center for Ophthalmic and Vision Recearch

    Manhattan, New York 10022
    United States

    Site Not Available

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