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| Name | Class |
|---|---|
| That Man May See, Inc. | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gerami D Seitzman, MD | Contact | +14154761442 | remotedryeye@ucsf.edu | |
| Brianna K Colado, BA | Contact | brianna.colado@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Gerami Seitzman, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | Recruiting | San Francisco | California | 94010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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 | ||
| 21045640 | 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. | |
| 28736337 |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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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.
| 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. | 4 weeks |
| 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. |
| 36301551 | 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. |
| 37661149 | 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. |
| 37654775 | 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. |
| 39172847 | 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. |
| 38127364 | 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. |