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A comparison of treatments to improve tear film and symptoms in dry eye disease.

Effect of Cyclosporine A (0.05%, 0.09%) and Lifitegrast (5%) Formulations on Tear Film Parameters In Dry Eye Disease - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/06/112247
Enrollment
80
Registered
2026-06-08
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Health Condition 1: H049- Disorder of lacrimal system, unspecified

Interventions

Control Intervention1: CYCLOSPORINE (0.05%, 0.09%) AND LIFITEGRAST (5%): CYCLOSPORINE (0.05%, 0.09%) AND LIFITEGRAST (5%) Control Intervention2: CYCLOSPORINE (0.05%, 0.09%) AND LIFITEGRAST (5%): study

Sponsors

NETHRADHAMA SUPER SPECIALITY EYE HOSPITAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adults aged 18 years and above. Patients clinically diagnosed with moderate to severe Dry Eye Disease, based on Tear BreakUp Time more than 10 seconds. Schirmer Test less than or equals to 10 mm in 5 minutes (without anesthesia). Patients with bilateral involvement of Dry Eye Disease. Willingness to provide written informed consent. Ability to comply with study procedures and follow-up visits.

Exclusion criteria

Exclusion criteria: History of ocular surgery or trauma within the last 3 months. Use of topical ophthalmic medications other than lubricating eye drops within the past 4 weeks, unless specified by the study protocol. History of hypersensitivity or known allergy to cyclosporine or any component of the study medications. Presence of autoimmune diseases (Sj gren syndrome, rheumatoid arthritis) if not stable or controlled. Contact lens wearers unwilling to discontinue lens use during the study period. Pregnant or lactating women. Participation in another clinical trial within the last 30 days.

Design outcomes

Primary

MeasureTime frame
compare the effect of Cyclosorine A (0.05%, 0.09%) and Lifitegrast (5%) on tear film stability as measured by Non-Invasive Tear Break-Up Time (NITBUT), Schirmer test, tear meniscus height (TMH), and Mebomian gland loss in patients with Dry Eye Disease.Timepoint: 3 MONTHS AND 6 MONTHS—

Secondary

MeasureTime frame
To evaluate & compare the effect of Cyclosporine (0.05%,0.09%) AND lifitegrast (5%) on tear production, assessed by Schirmer Test. To compare the patient reported symptoms of Dry Eye Disease using a validated questionnaire such as ocular surface disease index 6 (OSDI6)Timepoint: 3 MONTHS AND 6 MONTHS—

Countries

India

Contacts

Public ContactFARHANA KHATOON

NETHRADHAMA SCHOOL OF OPTOMETRY

viceprincipalnso@gmail.com9742536112

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026