Study for Remote Investigation of Evaporative Dry Eye Disease

Not yet recruiting

• Conditions: Evaporative Loss Dry Eye Disease

• Registration Number: NCT06976515
• Lead Sponsor: University of California, San Francisco

Brief 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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-07
• Study First Submitted QC: 2025-05-08
• Study First Posted: 2025-05-16
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-23
• Study Start: 2025-07-01
• Primary Completion: 2027-07-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Evaporative loss dry eye disease will be confirmed by screening clinical examination. Patients with evaporative loss dry eye disease will have minimal to no corneal staining and have normal aqueous (water) tear production. Eligible patients with evaporative loss dry eye disease over the age of 18 will be offered study participation.
• There will be no ethnic restrictions on enrollment. All adults (18 years of age or older) with evaporative loss dry eye disease regardless of race or ethnicity will be recruited for participation.
• All adults (18 years of age or older) with evaporative loss dry eye disease , regardless of sex/gender are eligible for recruitment. Women will not be excluded if they are pregnant or breastfeeding.
• All adults age 18 or older with evaporative loss dry eye disease will be recruited for participation. Dry eye disease is not common in the pediatric population and younger children would require assistance with electronic symptom logging and self-performed ocular surface sample collection. Therefore, this study of feasibility of decentralized dry eye disease study will exclude children.
• No treatment is administered in this non-interventional feasibility trial, therefore if pregnant women have dry eye they can participate with no risk to the fetus.

Exclusion Criteria

• Patients with keratoconjunctivitis sicca (clinically significant decrease in aqueous production) will not be included. This is because the population with this dry eye disease subtype is at higher risk for corneal epithelial breakdown and ocular surface infection.
• Patients unwilling to measure their own tear production at home will be excluded.
• Patients without internet access or reasonable proximity/access to a post box will be excluded.
• Eyedrop use is not an exclusion criterion.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Completion of Surveys and Receipt of Samples	4 weeks	The primary outcome is the rate of successful completion of the OSDI and SPEED surveys at two time points and the receipt of two clinical samples from two time points.

Secondary Outcome Measures

Name	Time	Method
Comparison of results of remote symptom surveys over time without intervention to inform variability	4 weeks
Quantification of Recoverable Human mRNA from Self-Collected Schirmer Strips for Transcriptome Analysis	4 weeks	The measurement used to assess this outcome will be the quantity of recoverable human mRNA extracted from self-collected Schirmer strips, expressed as the total number of high-quality, aligned transcript reads per sample after RNA sequencing.
Assessment of Intra-Participant Variability in Inflammatory Cytokine Gene Expression in Tears Over Time Using RNA Sequencing.	4 weeks	The measurement will be the expression levels of selected inflammatory cytokine genes, quantified as normalized transcript read counts derived from RNA sequencing data. Gene expression levels will be assessed at two time points, 4 weeks apart, with no intervention. Paired comparisons will be made to evaluate intra-participant variability and overall variance across the cohort.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States