Remote approach to understanding evaporative dry eye

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

This project tries a home-based approach to collect symptoms and self-collected eye samples from adults with evaporative dry eye to see if remote methods can work.

Quick facts

• Study type: Observational
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of California, San Francisco (Academic / other)
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT06976515 on ClinicalTrials.gov

What this trial studies

This non-interventional feasibility project uses a decentralized design to collect sequential electronic symptom reports and self-collected ocular surface samples from participants at home. Participants receive mailed kits with Schirmer strips and swabs, collect samples themselves at baseline and again after four weeks, and return samples by mail to the UCSF Proctor Foundation laboratory. Returned samples undergo RNA deep sequencing for host transcriptomic analysis to search for objective markers. The approach aims to increase participant diversity and make repeat sampling easier without clinic visits.

Who should consider this trial

Good fit: Adults (18 years or older) with confirmed evaporative loss dry eye who have minimal to no corneal staining, normal aqueous tear production, and the ability to self-collect samples and return mailed kits are ideal candidates.

Not a fit: People with aqueous-deficient dry eye, significant corneal damage, children, or those unable to perform self-collection or receive/return mailed kits likely will not benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could make it easier for more people to join dry eye research and identify objective, remotely collected markers to monitor evaporative dry eye.

How similar studies have performed: Remote, self-collection and decentralized trial methods are relatively novel for dry eye—previous dry eye trials have often struggled with enrollment and diversity, so this approach is exploratory rather than widely proven.

Eligibility criteria

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.

Where this trial is running

San Francisco, California

• University of California, San Francisco — San Francisco, California, United States (Recruiting)

Study contacts

• Principal investigator: Gerami Seitzman, MD — University of California, San Francisco
• Study coordinator: Gerami D Seitzman, MD

Conditions Evaporative Loss Dry Eye Disease; Dry Eye; Evaporative Loss Dry Eye