Comparing lifitegrast 5 percentage and cyclosporine 0.05 percentage eyedrops for treating moderate to severe dry eye disease.

A comparative study of efficacy, safety and quality of life with lifitegrast 5 percentage and cyclosporine 0.05 percentage eye drops in moderate to severe dry eye disease. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/098542

Enrollment

Registered

2025-12-05

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

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 Health Condition 2: H041- Other disorders of lacrimal gland

Interventions

Intervention1: lifitegrast: lifitegrast 5% eye drops twice a day daily for 12 weeks. Control Intervention1: cyclosporine: cyclosporine 0.05% eye drops twice a day , daily for 12 weeks.

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either gender from 18 to 80 years of age. Schirmers test 1: 0 to 10 mm or OSDI: 23 to100 Patients willing to give written informed consent.

Exclusion criteria

Exclusion criteria: Any ocular structural abnormalities (such as eyelid trichiasis, entropion, and scarring) The presence of pinguecula or pterygium Any active allergy, infection, or inflammatory disease at the ocular surface unrelated to dry eye Any inflammation or active structural change in the iris or anterior chamber Glaucoma Previous punctual occlusion or eye surgery A positive history of refractive surgery or contact lens wear Diabetic retinopathy or other systemic, dermatologic, or neurologic diseases that affect the health of the ocular surface Use of any other topical medication other than artificial tears within the past one month 10. Use of any systemic anti-inflammatory drugs or medication that may interfere with tear production, such as anti-anxiety, anti-depressive, and antihistamine medications within 3months Pregnant and lactating women Hypertensive retinopathy History of allergy to study medication

Design outcomes

Primary

Measure	Time frame
To assess the efficacy of Lifitegrast 5% and Cyclosporine 0.05% eyedrops in DED, by observing Tear film breakup time (TBUT), Schirmers Test -1 (ST- 1) and Corneal Fluorescein Staining (CFS).Timepoint: it will be assessed at baseline, 2weeks, 6weeks, and 12weeks.	—

Secondary

Measure	Time frame
To assess the safety of Lifitegrast 5% and Cyclosporine 0.05% eyedrops in DED by assessing ADR monitoring and ophthalmic examination throughout the study. To assess the quality of life with Lifitegrast 5% and cyclosporine 0.05% eyedrops in DED, by assessing the Ocular Surface Disease Index (OSDI), at baseline and 12 weeks. Timepoint: Safety assessment will be done throughout the study. Quality of life will be assessed at baeline and 12 weeks.	—

Measure

Time frame

To assess the safety of Lifitegrast 5% and Cyclosporine 0.05% eyedrops in DED by assessing ADR monitoring and ophthalmic examination throughout the study. To assess the quality of life with Lifitegrast 5% and cyclosporine 0.05% eyedrops in DED, by assessing the Ocular Surface Disease Index (OSDI), at baseline and 12 weeks. Timepoint: Safety assessment will be done throughout the study. Quality of life will be assessed at baeline and 12 weeks.

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Countries

India

Contacts

Public ContactMadhumita Valluvar

Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences

madhumitavalluvar19@gmail.com9566016112

Outcome results

None listed

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