Discovery and Detection of Dry Eye Disease Protein Biomarkers Using Soft Contact Lens Tear Sampling

Dry eye disease (DED) affects up to half of the world's population and causes blur, eye pain, decreased quality of life. Unfortunately, many people do not receive proper treatment due to current challenges associated with DED diagnoses. To address this issue, point-of-care (PoC) clinical tear film diagnostics are beginning to be used for rapid in-office testing. However, these diagnostics also have significant obstacles, including challenges associated with tear sampling. We previously demonstrated how soft contact lenses (SCLs) can be used to capture and concentrate tear proteins on the eye. Given the low tear volume associated with DED subjects, SCL sampling holds great potential to improve DED PoC diagnostics and facilitate prompt treatment for patients. Here we show the detection of new and established DED protein biomarkers using our SCL sampling method. Our analysis revealed associations between DED tear proteins and the immune system, ferroptosis, salivary secretion, and calcium binding proteins. We also identified correlations between clinical DED testing and proteomics, emphasizing the power and importance of translational medicine research. These experiments lay the foundation for both SCL sampled tear protein biomarker discovery as well as improved diagnostic testing to improve DED patient care. ### Competing Interest Statement Supplies and equipment were donated by AVC for the purposes of this study. Robert Roden was an employee of AVC. ### Funding Statement This study was funded by the Brigham Young University College of Physical and Mathematical Sciences. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The IRB of Brigham Young University gave ethical approval for this work. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced are available online at Mendeley Data