Multi-Parameter Analysis of Tear Film of Healthy and Suspected Dry Eye Patients using TeaRx Non-Invasive Point-of-care Testing Device: An Investigator Initiated Academic Trial

The International Dry Eye Workshop II 2017 defines dry eye disease[1] (DED) as “… amultifactorial disease of the ocular surface characterized by a loss ofhomeostasis of the tear film, and accompanied by ocular symptoms, in which tearfilm instability and hyperosmolarity, ocular surface inflammation and damage,and neurosensory abnormalities play etiological rolesâ€. The symptoms of DEDinclude ocular burning, foreign body sensation, soreness, stinging, irritation,reduced visual acuity, photophobia, and ocular pain. The burden of DED can varyfrom mild discomfort to severe complaints that impact daily activities, reduce thequality of life, and have significant socioeconomic implications. Theprevalence of DED increases with age and ranges from 5% to 50%

Accurate diagnosis of DED is complex and requires the applicationof a battery of tests, including questionnaires of patient-reported symptoms,tear film break-up time (TFBUT),  Schirmertest, ocular surface staining, and meibomian gland functionality. However,most of the tests lack consistency and reliability for diagnosing DED;therefore, they are subject to clinical interpretation based on experience. Thelack of a strong association between the signs and symptoms of DED is anotherchallenge clinicians face in diagnosing and following-up patients with thedisease. Numerous ancillary diagnostic tests have been developed to overcomethese challenges, including several patient-reported DED-specificquestionnaires and new tools enabling the quantification of tear filmcharacteristics.

DiagnoTear has developed a diagnostic technology that isbased on semiquantitative analysis of the tear film. The company’s first productconsists of a multivariate algorithm calculates a final numeric value thatis based on values of 5 parameters that include 3 biomarkers within the tearcontent: albumin, lactoferrin and lysozyme and takes into consideration age andgender. The data provides the physician with actionable information regardingtreatment strategy. As this is personalized, it is also a powerful means forfollow up of response to treatment.

The selection of those three specific markers was based onresults from 3 different clinical trials performed by DiagnosTear in which moremarkers have been tested. In those studies, the effectiveness of the developedassay was tested in diagnosing DED patients and comparing their results withresults obtained from healthy subjects. Furthermore, the sensitivity andspecificity of the results were compared to the 4 standard of care benchmarktests, assessing both signs and symptoms.