Analysis of Tear Film of Healthy and Suspected Dry Eye Patients

Not Applicable

Conditions: Health Condition 1: H041- Other disorders of lacrimal gland

Registration Number: CTRI/2020/12/029691

Lead Sponsor: V Prasad Eye Institute

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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)

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 <br/ ><br>b.Validating the recommended guidelines specified in TeaRx table by following-up the TeaRx test results changes as result of the treatment regimens <br/ ><br>c.Setting the TeaRx â??thresholdsâ?? of the different parameters to distinguish between dry eye sub-types <br/ ><br>Timepoint: Baseline, 1 month, 3 month, 6 month <br/ ><br>

Secondary Outcome Measures