ClinicalTrials.gg
Not yet recruitingNCT07933874WE CRIEDUpdated Nov 12, 2026

Decentralized Dry Eye Study, Planning & Feasibility

An observational study in Evaporative Loss Dry Eye Disease, sponsored by University of California, San Francisco. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by University of California, San Francisco · Observational

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 543 studies in Dry Eye Syndromes with a site in United States — 52 open to participants now, 62 under way, 3 of them phase 3. Dry Eye Syndromes · United States.

Planned enrollment
44th of 64
50 · median 80
Started
2026
with 34 others
Observational
64 of 543
11 open now
Primary completion
2027-09
later than 49 of 61 live
Registered
542nd of 543
by date

Among the 543 studies in Dry Eye Syndromes with a site in United States, this one is the 44th largest by planned enrollment of the 64 observational ones that give a count, is one of 35 that started in 2026, is one of 64 observational ones, reaches primary completion later than 49 of the 61 other live ones, and was the 542nd registered.

Dry Eye Syndromes

1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.

Browse Dry Eye Syndromes studies →

Open to participants now

52 of the 543 studies in Dry Eye Syndromes with a site in United States are open now. Recruiting first, the newest first:

47 more — sign in →

All 52 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 116 Dry Eye Syndromes studies recruiting now, 73 (63%) set no upper age limit and 24 (21%) stop at 75 or younger; 7 take children under 18; 29 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 543 studies in Dry Eye Syndromes with a site in United States, or all of them as a file.
02

Study 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.

Read the 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.

This entry is for the expanded national recruitment cohort for the Study for Remote Investigation of Evaporative Dry Eye Disease. The expanded recruitment study is called WE CRIED and is funded by an R34 feasibility mechanism (NCT06976515). Note, a local to UCSF feasibility study called ICRIED is reported under a different entry. Both the UCSF local study and this expanded recruitment national portion of this study have been reviewed by the UCSF Institutional Review Board and are approved under the same Unique Protocol ID: 25-43371. We have included the unique protocol ID with the character "a" at the end of the WECRIED entry to differentiate the records.

03

Conditions studied

  • Evaporative Loss Dry Eye Disease

Browse trials for

Keywords

  • Dry Eye
  • Evaporative Loss Dry Eye
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Our study will enroll patients over the age of 18 with evaporative loss dry eye disease with minimal to no corneal staining and normal tear production.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients with keratoconjunctivitis sicca ( 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Expanded Remote Recruitment Group

    This is the expanded study of the Study for Remote Investigation of Evaporative Dry Eye Disease (ICRIED). Recruitment will be open to the U.S. 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.

06

What researchers measure

Primary outcomes

  1. Completion of Surveys and Receipt of Samples

    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.

    Time frame: 4 weeks

Secondary outcomes

  1. Comparison of results of remote symptom surveys over time without intervention to inform variability

    Time frame: 4 weeks

  2. Quantification of Recoverable Human mRNA from Self-Collected Schirmer Strips for Transcriptome Analysis

    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.

    Time frame: 4 weeks

  3. Quantification of Recoverable Human RNA from Self-Collected Eyelid Swabs for Transcriptome Analysis

    The measurement used to assess this outcome will be the quantity of recoverable human RNA extracted from self-collected eyelid swabs, expressed as the total number of high-quality, aligned transcript reads per sample after RNA sequencing.

    Time frame: 4 weeks

  4. Assessment of Intra-Participant Variability in Inflammatory Cytokine Gene Expression in Tears Over Time Using RNA Sequencing.

    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.

    Time frame: 4 weeks

07

Study locations

1 site
08

References and documents

Publications

  • McCann P, Abraham AG, Mukhopadhyay A, Panagiotopoulou K, Chen H, Rittiphairoj T, Gregory DG, Hauswirth SG, Ifantides C, Qureshi R, Liu SH, Saldanha IJ, Li T. Prevalence and Incidence of Dry Eye and Meibomian Gland Dysfunction in the United States: A Systematic Review and Meta-analysis. JAMA Ophthalmol. 2022 Dec 1;140(12):1181-1192. doi: 10.1001/jamaophthalmol.2022.4394. PubMed 36301551 ↗
  • Dry Eye Assessment and Management Study Research Group; Asbell PA, Maguire MG, Pistilli M, Ying GS, Szczotka-Flynn LB, Hardten DR, Lin MC, Shtein RM. n-3 Fatty Acid Supplementation for the Treatment of Dry Eye Disease. N Engl J Med. 2018 May 3;378(18):1681-1690. doi: 10.1056/NEJMoa1709691. Epub 2018 Apr 13. PubMed 29652551 ↗
  • Sinha SD, Chary Sriramadasu S, Raphael R, Roy S. Decentralisation in Clinical Trials and Patient Centricity: Benefits and Challenges. Pharmaceut Med. 2024 Mar;38(2):109-120. doi: 10.1007/s40290-024-00518-x. Epub 2024 Mar 7. PubMed 38453755 ↗
  • Kelsey MD, Patrick-Lake B, Abdulai R, Broedl UC, Brown A, Cohn E, Curtis LH, Komelasky C, Mbagwu M, Mensah GA, Mentz RJ, Nyaku A, Omokaro SO, Sewards J, Whitlock K, Zhang X, Bloomfield GS. Inclusion and diversity in clinical trials: Actionable steps to drive lasting change. Contemp Clin Trials. 2022 May;116:106740. doi: 10.1016/j.cct.2022.106740. Epub 2022 Mar 29. PubMed 35364292 ↗
  • Sehrawat O, Noseworthy PA, Siontis KC, Haddad TC, Halamka JD, Liu H. Data-Driven and Technology-Enabled Trial Innovations Toward Decentralization of Clinical Trials: Opportunities and Considerations. Mayo Clin Proc. 2023 Sep;98(9):1404-1421. doi: 10.1016/j.mayocp.2023.02.003. PubMed 37661149 ↗
  • Miyata BL, Tafuto B, Jose N. Methods and perceptions of success for patient recruitment in decentralized clinical studies. J Clin Transl Sci. 2023 Oct 6;7(1):e232. doi: 10.1017/cts.2023.643. eCollection 2023. PubMed 38028356 ↗
  • Asbell PA, Maguire MG. Another Disappointment for omega-3 Fatty Acid and Dry Eye Disease. JAMA Ophthalmol. 2022 Jul 1;140(7):714-715. doi: 10.1001/jamaophthalmol.2022.1821. No abstract available. PubMed 35679039 ↗
  • de Paiva CS, Pflugfelder SC, Ng SM, Akpek EK. Topical cyclosporine A therapy for dry eye syndrome. Cochrane Database Syst Rev. 2019 Sep 13;9(9):CD010051. doi: 10.1002/14651858.CD010051.pub2. PubMed 31517988 ↗
  • McCann P, Kruoch Z, Lopez S, Malli S, Qureshi R, Li T. Interventions for Dry Eye: An Overview of Systematic Reviews. JAMA Ophthalmol. 2024 Jan 1;142(1):58-74. doi: 10.1001/jamaophthalmol.2023.5751. PubMed 38127364 ↗
  • Montecchi-Palmer M, Wu M, Rolando M, Lau C, Perez Quinones VL, Dana R. Possible Strategies to Mitigate Placebo or Vehicle Response in Dry Eye Disease Trials: A Narrative Review. Ophthalmol Ther. 2023 Aug;12(4):1827-1849. doi: 10.1007/s40123-023-00720-1. Epub 2023 May 20. PubMed 37208548 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Sep 2027, 9 months later.

Of 53 non-industry observational studies under Dry Eye Syndromes, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 64. This study's planned 9 months is below that.

Counting every sponsor, half of 69 studies reached it within 12 months; a quarter within 5 and three quarters within 64.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 5, 2026
First posted
Nov 12, 2026
StartEst.
Dec 10, 2026
Primary completionEst.
Sep 29, 2027
CompletionEst.
Sep 29, 2027
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07933874
Responsible party
Sponsor
First posted
Nov 12, 2026
Start date
Dec 10, 2026 (estimated)
Primary completion
Sep 29, 2027 (estimated)
Completion
Sep 29, 2027 (estimated)
Last update
Nov 12, 2026

Study contacts

Gerami D Seitzman, MD
Contact
remotedryeye@ucsf.edu
+14154761442
Brianna Colado
Contact
brianna.colado@ucsf.edu
Gerami Seitzman, MD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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