Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT06976515

Conditions

Evaporative Loss Dry Eye Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Evaporative Loss Dry Eye Disease

Study ID

NCT06976515

Start date

Sep 1, 2025

Status verified date

Oct, 2025

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

90 participants

Anticipated

Interventions and Outcome Measures

Arms

UCSF Recruitment Group

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

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.

Primary outcome measure

  • Completion of Surveys and Receipt of Samples [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Brianna K Colado, BA

brianna.colado@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94010

Contacts

Principal Investigator:

Gerami D Seitzman, MD

More Information

Sponsor

University of California, San Francisco

Last update posted

Oct 9, 2025

Last verified

Oct, 2025

Keywords

  • Dry Eye
  • Evaporative Loss Dry Eye

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2025-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.