CTRI Number	CTRI/2020/12/029691 [Registered on: 09/12/2020] Trial Registered Prospectively
Last Modified On:	29/01/2021
Post Graduate Thesis	No
Type of Trial	Observational
Type of Study	Case Control Study
Study Design	Non-randomized, Placebo Controlled Trial
Public Title of Study	Analysis of Tear Film of Healthy and Suspected Dry Eye Patients
Scientific Title of Study	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
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  DrSayan Basu  Address  L V Prasad Eye Institute, Kallam Anji Reddy Campus,Room No: 123, ist floor, GPR Building,L.V Prasad Marg, Banjara Hills, Road No: 2, Hyderabad-500034, Telangana. Hyderabad TELANGANA 500034 India  Phone  04068102534   Fax  04023548271   Email  sayanbasu@lvpei.org
Details Contact Person Scientific Query Modification(s)	Name  DrSayan Basu  Address  L V Prasad Eye Institute, Kallam Anji Reddy Campus,Room No: 123, ist floor, GPR Building, L.V Prasad Marg, Banjara Hills, Road No: 2, Hyderabad-500034, Telangana. Hyderabad TELANGANA 500034 India  Phone  04068102534   Fax  04023548271   Email  sayanbasu@lvpei.org
Details Contact Person Public Query Modification(s)	Name  DrSayan Basu  Address  L V Prasad Eye Institute, Kallam Anji Reddy Campus,Room No: 123, ist floor, GPR Building, L.V Prasad Marg, Banjara Hills, Road No: 2, Hyderabad-500034, Telangana. Hyderabad TELANGANA 500034 India  Phone  04068102534   Fax  04023548271   Email  sayanbasu@lvpei.org
Source of Monetary or Material Support Modification(s)	L V Prasad Eye Institute, Kallam Anji Reddy Campus, Banjara Hills,Road No: 02, Hyderabad-500034,Telangana, India
Primary Sponsor	Name  L V Prasad Eye Institute  Address  LV Prasad Eye Institute, Kallam Anji Reddy Campus, GPR Building, L.V Prasad Marg, Banjara Hills, Road No: 2, Hyderabad-500034, Telangana.  Type of Sponsor  Other [Non Profitable Organization]
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Sayan Basu  L V Prasad Eye Institute  Room No: 123, 1st floor, GPR Building,Kallam Anji Reddy Campus,L.V Prasad Marg, Banjara Hills, Road No: 2, Hyderabad-500034, Telangana. Hyderabad   04068102534 04023548271 sayanbasu@lvpei.org
Details of Ethics Committee	No of Ethics Committees= 1   Name of Committee  Approval Status  Ethics Committee, L V Prasad Eye Institute  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Patients  Other disorders of lacrimal gland
Intervention / Comparator Agent	Type  Name  Details  Intervention  NA  NA  Comparator Agent  NA  NA
Inclusion Criteria	Age From  18.00 Year(s) Age To  90.00 Year(s) Gender  Both  Details  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
ExclusionCriteria	Details  1. 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)
Method of Generating Random Sequence	Not Applicable
Method of Concealment	Not Applicable
Blinding/Masking	Not Applicable
Primary Outcome	Outcome  TimePoints  a. Validate the TeaRx ability to Diagnose Dry Eye Syndrome (DED) and distinguish between healthy and suspected dry eye subjects b. Validating the recommended guidelines specified in TeaRx table by following-up the TeaRx test results changes as result of the treatment regimens c. Setting the TeaRx “thresholds” of the different parameters to distinguish between dry eye sub-types   Baseline, 1 month, 3 month, 6 month
Secondary Outcome	Outcome  TimePoints  NA  NA
Target Sample Size	Total Sample Size="600" Sample Size from India="600"
Phase of Trial	N/A
Date of First Enrollment (India)	15/12/2020
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="2" Months="1" Days="1"
Recruitment Status of Trial (Global)	Not Applicable
Recruitment Status of Trial (India)	Not Yet Recruiting
Publication Details Modification(s)	NIL
Brief Summary	The International Dry Eye Workshop II 2017 defines dry eye disease[1] (DED) as “… a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles”. The symptoms of DED include ocular burning, foreign body sensation, soreness, stinging, irritation, reduced visual acuity, photophobia, and ocular pain. The burden of DED can vary from mild discomfort to severe complaints that impact daily activities, reduce the quality of life, and have significant socioeconomic implications. The prevalence of DED increases with age and ranges from 5% to 50% Accurate diagnosis of DED is complex and requires the application of a battery of tests, including questionnaires of patient-reported symptoms, tear film break-up time (TFBUT),  Schirmer test, 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. The lack of a strong association between the signs and symptoms of DED is another challenge clinicians face in diagnosing and following-up patients with the disease. Numerous ancillary diagnostic tests have been developed to overcome these challenges, including several patient-reported DED-specific questionnaires and new tools enabling the quantification of tear film characteristics. DiagnoTear has developed a diagnostic technology that is based on semiquantitative analysis of the tear film. The company’s first product consists of a multivariate algorithm calculates a final numeric value that is based on values of 5 parameters that include 3 biomarkers within the tear content: albumin, lactoferrin and lysozyme and takes into consideration age and gender. The data provides the physician with actionable information regarding treatment strategy. As this is personalized, it is also a powerful means for follow up of response to treatment. The selection of those three specific markers was based on results from 3 different clinical trials performed by DiagnosTear in which more markers have been tested. In those studies, the effectiveness of the developed assay was tested in diagnosing DED patients and comparing their results with results obtained from healthy subjects. Furthermore, the sensitivity and specificity of the results were compared to the 4 standard of care benchmark tests, assessing both signs and symptoms.