Evaporative Loss Dry Eye DiseaseI CRIEDNCT06976515
Study for Remote Investigation of Evaporative Dry Eye Disease
An observational study of Evaporative Loss Dry Eye Disease, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Evaporative Loss Dry Eye Disease
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94010
About this study
Official title: Initial Cohort Study for Remote Investigation of Eye Dryness: A Pilot and Feasibility Study
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.
- Conditions
- Evaporative Loss Dry Eye Disease
- Keywords
- Dry Eye, Evaporative Loss Dry Eye
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (3)
Comparison of results of remote symptom surveys over time without intervention to inform variability
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start1 Sep 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Evaporative Loss Dry Eye DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- That Man May See, Inc.
- Responsible party
- Sponsor
- Investigators
- Gerami Seitzman, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976515
- Sponsor's protocol ID
- 25-43371
- Acronym
- I CRIED
- Status last verified
- Oct 2026
- First submitted
- 7 May 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
"Uninformative research" is the global health crisis you've never heard of. The Gates Foundation. Accessed September 23, 2024. https://www.gatesfoundation.org/ideas/articles/deworm3-clinical-trialsshow- the-value-of-informed-researchhttps://www.gatesfoundation.org/ideas/articles/deworm3-clinicaltrials- show-the-value-of-informed-research
Yu J, Asche CV, Fairchild CJ. The economic burden of dry eye disease in the United States: a decision tree analysis. Cornea. 2011 Apr;30(4):379-87. doi: 10.1097/ICO.0b013e3181f7f363.
PubMed 21045640Stapleton F, Alves M, Bunya VY, Jalbert I, Lekhanont K, Malet F, Na KS, Schaumberg D, Uchino M, Vehof J, Viso E, Vitale S, Jones L. TFOS DEWS II Epidemiology Report. Ocul Surf. 2017 Jul;15(3):334-365. doi: 10.1016/j.jtos.2017.05.003. Epub 2017 Jul 20.
PubMed 28736337McCann 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 36301551Sehrawat 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 37661149Hanley DF Jr, Bernard GR, Wilkins CH, Selker HP, Dwyer JP, Dean JM, Benjamin DK Jr, Dunsmore SE, Waddy SP, Wiley KL Jr, Palm ME, Mould WA, Ford DF, Burr JS, Huvane J, Lane K, Poole L, Edwards TL, Kennedy N, Boone LR, Bell J, Serdoz E, Byrne LM, Harris PA. Decentralized clinical trials in the trial innovation network: Value, strategies, and lessons learned. J Clin Transl Sci. 2023 Jul 25;7(1):e170. doi: 10.1017/cts.2023.597. eCollection 2023.
PubMed 37654775Jean-Louis G, Seixas AA. The value of decentralized clinical trials: Inclusion, accessibility, and innovation. Science. 2024 Aug 23;385(6711):eadq4994. doi: 10.1126/science.adq4994. Epub 2024 Aug 23.
PubMed 39172847McCann 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Cohort Study for Remote Investigation of Eye Dryness: A Pilot and Feasibility Study
- ClinicalTrials.gov ID
- NCT06976515
- Acronym / sponsor ID
- I CRIED / 25-43371
- Conditions
- Evaporative Loss Dry Eye Disease
- Keywords
- Dry Eye, Evaporative Loss Dry Eye
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- That Man May See, Inc.
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Completion of Surveys and Receipt of Samples
Time frame: 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.
3 secondary outcomes
Comparison of results of remote symptom surveys over time without intervention to inform variability
Time frame: 4 weeks
Quantification of Recoverable Human mRNA from Self-Collected Schirmer Strips for Transcriptome Analysis
Time frame: 4 weeks
Assessment of Intra-Participant Variability in Inflammatory Cytokine Gene Expression in Tears Over Time Using RNA Sequencing.
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background"Uninformative research" is the global health crisis you've never heard of. The Gates Foundation. Accessed September 23, 2024. https://www.gatesfoundation.org/ideas/articles/deworm3-clinical-trialsshow- the-value-of-informed-researchhttps://www.gatesfoundation.org/ideas/articles/deworm3-clinicaltrials- show-the-value-of-informed-research
- Background: PubMed 21045640Yu J, Asche CV, Fairchild CJ. The economic burden of dry eye disease in the United States: a decision tree analysis. Cornea. 2011 Apr;30(4):379-87. doi: 10.1097/ICO.0b013e3181f7f363.
- Background: PubMed 28736337Stapleton F, Alves M, Bunya VY, Jalbert I, Lekhanont K, Malet F, Na KS, Schaumberg D, Uchino M, Vehof J, Viso E, Vitale S, Jones L. TFOS DEWS II Epidemiology Report. Ocul Surf. 2017 Jul;15(3):334-365. doi: 10.1016/j.jtos.2017.05.003. Epub 2017 Jul 20.
- Background: PubMed 36301551McCann 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.
- Background: PubMed 37661149Sehrawat 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.
- Background: PubMed 37654775Hanley DF Jr, Bernard GR, Wilkins CH, Selker HP, Dwyer JP, Dean JM, Benjamin DK Jr, Dunsmore SE, Waddy SP, Wiley KL Jr, Palm ME, Mould WA, Ford DF, Burr JS, Huvane J, Lane K, Poole L, Edwards TL, Kennedy N, Boone LR, Bell J, Serdoz E, Byrne LM, Harris PA. Decentralized clinical trials in the trial innovation network: Value, strategies, and lessons learned. J Clin Transl Sci. 2023 Jul 25;7(1):e170. doi: 10.1017/cts.2023.597. eCollection 2023.
- Background: PubMed 39172847Jean-Louis G, Seixas AA. The value of decentralized clinical trials: Inclusion, accessibility, and innovation. Science. 2024 Aug 23;385(6711):eadq4994. doi: 10.1126/science.adq4994. Epub 2024 Aug 23.
- Background: PubMed 38127364McCann 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerami Seitzman, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Evaporative Loss Dry Eye Disease, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of Surveys and Receipt of Samples (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06976515, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.