Study for Remote Investigation of Evaporative Dry Eye Disease (I CRIED)

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: Evaporative Loss Dry Eye Disease

Study type: Observational

Funder types: Other

Identifiers

NCT06976515

25-43371

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

90 participants in 2 patient groups

UCSF Recruitment Group

Description:

For this feasibility trial any patient identified in the eye clinics of the UCSF Department of Ophthalmology, Optometry, or Proctor Foundation clinic with evaporative dry eye as a primary diagnosis will be queried with regard to participation interest. Participants are recruited in person but are consented remotely. To mimic a larger, scalable, future-anticipated recruitment strategy, interested participants will be asked to scan a QR code to indicate interest in the study. Study information will be posted in clinic rooms and waiting rooms.

Remote Recruitment Group

Description:

Anterior Segment Delegates of Optometry have specialty training in ocular surface disease and are located across the entire United States. Study information will be sent to Anterior Segment Delegates of the American Board of Optometry who have expressed interest in this study design. Recruitment sheets will be offered for them to post in their clinics and waiting rooms. Once an Anterior Segment delegate has confirmed dry eye disease in the interested participant, they will scan the study QR code to indicate interest in the study. Alternatively, if sample size is not met we will recruit through ophthalmology listservs. All participants recruited through anterior segment delegates or listservs will give permission for their eye doctor to be contacted to confirm evaporative dry eye is their primary diagnosis and that no exclusion criteria exist.