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OpenTrials
Completed

NCT Number: NCT04835623

CEQUA for Sjogren's Syndrome Dry Eye

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cyclosporine 0.09% Ophthalmic Solution

Drug

one drop each eye twice daily

Other names: Cequa Ophthalmic Product

Primary outcomes

  1. Mean change from baseline in total corneal staining

    Time frame: Baseline and week 12

    Expanded NEI corneal staining scale ranging from 0 to 15

Secondary outcomes

  1. Mean change from baseline in total conjunctival staining

    Time frame: Baseline and week 12

    Expanded NEI conjunctival staining scale ranging from 0 to 20

  2. Mean change from baseline in the score of dry eye questionnaires

    Time frame: Baseline and week 12

    Dry eye questionnaire score ranging from 0 to 28

Sponsors and collaborators

Lead sponsor

Center for Ophthalmic and Vision Research, LLC

Other

Collaborators

  • Sun Pharmaceutical Industries Limited

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 8, 2021
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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