Decentralized Dry Eye Study, Planning & Feasibility (WE CRIED)
Remote Dry Eye Wider Enrollment Cohort 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.
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Gerami D Seitzman, MD
- Telefonnummer: +14154761442
- E-post: remotedryeye@ucsf.edu
Studer Kontakt Backup
- Navn: Brianna Colado
- E-post: brianna.colado@ucsf.edu
Studiesteder
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California
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San Francisco, California, Forente stater, 94158
- University of California, San Francisco
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Ta kontakt med:
- Gerami Seitzman, MD
- Telefonnummer: 415-476-1442
- E-post: remotedryeye@ucsf.edu
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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.
Beskrivelse
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:
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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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
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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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Completion of Surveys and Receipt of Samples
Tidsramme: 4 weeks
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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
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Sammenligning av resultatene av eksterne symptomundersøkelser over tid uten intervensjon for å informere om variabilitet
Tidsramme: 4 uker
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4 uker
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Quantification of Recoverable Human mRNA from Self-Collected Schirmer Strips for Transcriptome Analysis
Tidsramme: 4 weeks
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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. |
4 weeks
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Assessment of Intra-Participant Variability in Inflammatory Cytokine Gene Expression in Tears Over Time Using RNA Sequencing.
Tidsramme: 4 weeks
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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
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Quantification of Recoverable Human RNA from Self-Collected Eyelid Swabs for Transcriptome Analysis
Tidsramme: 4 weeks
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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. |
4 weeks
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Gerami Seitzman, MD, University of California, San Francisco
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 25-43371 a
- 1R34EY037743-01 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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