Center for Ophthalmic and Vision Recearch
Manhattan, New York, 10022, United States
NCT Number: NCT04835623
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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Notify Me18 year–70 year
All sexes
Interventional
Phase 4
Manhattan, New York, 10022, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
one drop each eye twice daily
Other names: Cequa Ophthalmic Product
Time frame: Baseline and week 12
Expanded NEI corneal staining scale ranging from 0 to 15
Time frame: Baseline and week 12
Expanded NEI conjunctival staining scale ranging from 0 to 20
Time frame: Baseline and week 12
Dry eye questionnaire score ranging from 0 to 28
Center for Ophthalmic and Vision Research, LLC
Other
Effects of CEQUA™ on Objective and Subjective Dry Eye Findings Associated With Sjogren's Syndrome
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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