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Analysis of Tear Film of Healthy and Suspected Dry Eye Patients

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/12/029691
Enrollment
600
Registered
2020-12-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H041- Other disorders of lacrimal gland

Interventions

Intervention1: NA: NA Control Intervention1: NA: NA

Sponsors

L V Prasad Eye Institute
Lead Sponsor

Eligibility

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
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 â??thresholdsâ?? of the different parameters to distinguish between dry eye sub-types Timepoint: Baseline, 1 month, 3 month, 6 month—

Secondary

MeasureTime frame
NATimepoint: NA—

Countries

India

Contacts

Public ContactDrSayan Basu

L V Prasad Eye Institute

sayanbasu@lvpei.org04068102534

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026