Study for Remote Investigation of Evaporative Dry Eye Disease

NCT06976515 | Recruiting

• 1 other identifier: 25-43371
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

Dry Eye; Evaporative Loss Dry Eye

Outcome Measures

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.

  4 weeks

Secondary Outcomes (3)

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

  4 weeks

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

  4 weeks

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

  4 weeks

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• That Man May See, Inc.: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94010, United States

RECRUITING

Related Publications (8)

• "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

• 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.

  PMID: 21045640 BACKGROUND

• Stapleton 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.

  PMID: 28736337 BACKGROUND

• 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.

  PMID: 36301551 BACKGROUND

• 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.

  PMID: 37661149 BACKGROUND

• Hanley 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.

  PMID: 37654775 BACKGROUND

• Jean-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.

  PMID: 39172847 BACKGROUND

• 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.

  PMID: 38127364 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Self-collected tear production measurement. This is called a Schirmer test. Self-collected eyelid swab. Only the remote recruitment group will be asked to perform this.

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Gerami Seitzman, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerami D Seitzman, MD

CONTACT

+14154761442; remotedryeye@ucsf.edu

Brianna K Colado, BA

CONTACT

brianna.colado@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 16, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: October 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)