Analysis of Tear Film of Healthy and Suspected Dry Eye Patients

Not yet recruiting

Conditions: Other disorders of lacrimal gland,

Registration Number: CTRI/2020/12/029691

Lead Sponsor: L V Prasad Eye Institute

Brief Summary: The International Dry Eye Workshop II 2017 defines dry eye disease[[1]](#_ftn1) (DED) as *â€œâ€¦ 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 roles*â€. 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 companyâ€™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.

---

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 600

Inclusion Criteria

1.Be 18 years of age and may be of any race and either gender; 2.2.Be able to read, sign, and date the IRB approved informed consent Additionally, the informed consent must be signed and dated by the individual consenting the subject; 3.3.Agree for samples to be taken from both eyes; 4.4.Be willing to follow the study procedures and visit schedule; 5.5.Meet the applicable DED criteria or Negative Control.

Exclusion Criteria

Allergy to topical anesthetic or fluorescein dye 2.Prior eye injury, trauma, or ocular surgery within the last 3 months.
3.Known blockage of the lacrimal drainage system 4.Contact lens wear in the last week 5.Previous corneal refractive surgery including RK, LASIK or PRK surgery 6.Have an active ocular infection or history of a recent ocular infection in the last two weeks 7.Have active intraocular inflammation or history of intraocular inflammation, e.g. Uveitis 8.Use of oral doxycycline, corticosteroids, or immunomodulators in the last month 9.Have received topical ocular corticosteroids, topical Nonsteroidal (NSAIDs) therapy, or topical ocular cyclosporine in the last month 10.Pregnant or lactating 11.Use of any topical ophthalmic medications in the last week (except artificial tears unless used less than 2 hours prior to enrollment).

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
a.Validate the TeaRx ability to Diagnose Dry Eye Syndrome (DED) and distinguish between healthy and suspected dry eye subjects	Baseline, 1 month, 3 month, 6 month
b.Validating the recommended guidelines specified in TeaRx table by following-up the TeaRx test results changes as result of the treatment regimens	Baseline, 1 month, 3 month, 6 month
c.Setting the TeaRx â€œthresholdsâ€ of the different parameters to distinguish between dry eye sub-types	Baseline, 1 month, 3 month, 6 month

Secondary Outcome Measures

Name	Time	Method
NA	NA

Trial Locations

Locations (1): L V Prasad Eye Institute
🇮🇳
Hyderabad, TELANGANA, India
L V Prasad Eye Institute
🇮🇳Hyderabad, TELANGANA, India
Dr Sayan Basu
Principal investigator
04068102534
sayanbasu@lvpei.org