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A study to assess the effect of treatment on patients with dry eye disease and to compare the two treatment options

A comparative study to evaluate clinicopathological changes associated with usage of topical cyclosporine A 0.09 percent versus lifitegrast 5 percent eyedrops in patients with dry eye disease. - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092978
Enrollment
200
Registered
2025-08-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: H578- Other specified disorders of eye and adnexa

Interventions

Intervention1: Topical Cyclosporine 0.09 percent: Twice a day for 12 weeks Control Intervention1: Lifitegrast 5 percent: Twice a day dose for 12 weeks

Sponsors

Sankara eye hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Mild to moderate dry eye disease Stain score more than 3 and less than 9 Symptom score more than 7 Patients willing to discontinue current therapy

Exclusion criteria

Exclusion criteria: Patients on immunomodulator therapy within 3 months Patients with glaucoma, Uveitis, tumors, trauma history Patients with previous corneal surgery

Design outcomes

Primary

MeasureTime frame
Clinical evaluation Keratograph Schirmers TBUT Corneal and Conjunctival staining score Patient response scoreTimepoint: Baseline and week 12—

Secondary

MeasureTime frame
Pathological evaluation by impression cytology Conjunctival goblet cell density Squamous metaplasia Epithelial integrityTimepoint: Baseline and week 12—

Countries

India

Contacts

Public ContactDr Mansi Mistry

Sankara eye hospital

drmansimistry@gmail.com8879624413

Outcome results

None listed

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