Vevye®
DrugParticipants will receive Vevye® (0.1% cyclosporine ophthalmic solution) as per the schedule described in the treatment arm.
Other names: Cyclosporine Ophthalmic Solution
NCT Number: NCT07025811
This study aims to evaluate the performance of biomarkers and their responsiveness to standard-of-care treatments (Vevye® or Xiidra®), in participants with dry eye disease (DED) compared to healthy volunteers (control participants).
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Eye Research Foundation, Newport Beach, California, United States
This study aims to characterize longitudinal changes in signs, symptoms, molecular, and imaging markers of the ocular surface to investigate pathological mechanisms and biomarkers (BMs) of DED after treatment with either of two commercially approved therapeutics (Vevye® [cyclosporine ophthalmic solution], Xiidra® [liftegrast ophthalmic solution]).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
A. Inclusion Criteria for Participants with DED:
B. Inclusion Criteria for Healthy Volunteers:
Exclusion criteria
Participants will receive Vevye® (0.1% cyclosporine ophthalmic solution) as per the schedule described in the treatment arm.
Other names: Cyclosporine Ophthalmic Solution
Participants will receive Xiidra® (5% lifitegrast ophthalmic solution) as per the schedule described in the treatment arm.
Other names: Lifitegrast Ophthalmic Solution
Time frame: Up to Week 12
Hoffmann-La Roche
Industry
A Longitudinal, Open-label, Multi-center Study to Explore the Relationship Between Signs, Symptoms, Molecular and Imaging Biomarkers in Participants With Dry Eye Disease Following Anti-inflammatory Treatment
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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