Study for Remote Investigation of Evaporative Dry Eye Disease

This is a feasibility study, this is not an interventional study. This proposal outlines a novel approach to the study of dry eye disease through a decentralized clinical trial design. This non-interventional planning and feasibility proposal shifts the focus of dry eye disease study away from doctors' offices and into participants' home environments. Subjective dry eye disease symptoms are collected remotely, electronically, and sequentially. Self-collected ocular surface samples are collected with self-collected Schirmer strips. All study materials are mailed to participants' homes. Self-collected ocular surface samples are placed in study vials and return-mailed by the participant to a central location, UCSF Proctor Foundation laboratory. Here, the samples are processed for RNA-deep sequencing which allows for host transcriptomic analysis. To mimic repeat ocular surface collection after a future dry eye disease intervention, Schirmer strips will be repeated after 4 weeks. This decentralized approach to dry eye disease study promotes patient engagement, recruitment, communication, and participant diversity and also seeks to identify new objective markers of dry eye disease efficacy that can be collected remotely. This entry called I CRIED is for the UCSF participant only portion of this study. The expanded national remote recruitment portion (WECRIED) can be found in the ct.gov record titled "Remote Dry Eye Wider Enrollment Cohort Study (WECRIED)." Both the UCSF portion and the expanded national portion of this study have been reviewed by the UCSF Insititutional Review Board and approved under the same Unique Protocol ID: 25-43371. We have included the unique protocol ID with the character "a" at the end of the WE CRIED record to differentiate the two portions of the study.