NCT06976515

Study for Remote Investigation of Evaporative Dry Eye Disease

Initial Cohort Study for Remote Investigation of Eye Dryness: A Pilot and Feasibility Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 90 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Dry eye disease is a common problem that can make your eyes feel uncomfortable and affect your vision, making daily tasks harder. Many past studies on dry eye treatments haven't worked well because they didn't include enough people or different types of people. Doing studies at home instead of at the doctor's office can help more people join and make it easier to find out which treatments really work.

Detailed description

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 in two ways: with a self-collected Schirmer strips and with a self-collected ocular surface swab of the eyelid margin and conjunctiva. 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 and ocular surface self-swabbing 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.

Conditions

• Evaporative Loss Dry Eye Disease

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2025-05-16
• Last updated: 2025-10-09

Locations

1 site across 1 country: United States