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A study comparing two different formulations of topical cyclosporine in patients with dry eye disease

Comparison of two formulation of topical cyclosporine in dry eye disease. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/108319
Enrollment
110
Registered
2026-04-13
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: H04- Disorders of lacrimal system

Interventions

Intervention1: Cyclosporine 0.09% nanomicellar solution: Topical cyclosporine 0.09% nanomicellar solution, administered as one drop in each eye twice daily for 6 months, along with carboxymethylcellul

Sponsors

Dr. Rajendra Prasad Centre for Ophthalmic Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Bilateral dry eye disease- freshly diagnosed cases and previously diagnosed cases with a washout period of 2 weeks Age more tha 18 years Objective criteria for diagnosis of dry eye disease OSDI score more than 13 Patients willing to follow up

Exclusion criteria

Exclusion criteria: Age less than 18 years Pregnancy Lactation History of recent contact lens wearing Any systemic medications (including over the counter/ herbal/ nutritional supplements) Systemic autoimmune diseases (including sjogrens) Any ocular infection or inflammation including blepharitis Not willing to give written consent or follow up

Design outcomes

Primary

MeasureTime frame
To compare the efficacy of both [0.05% oil in water emulsion vs 0.09% nanomicellar solution] of cyclosporine in management of dry eye disease.Timepoint: All patients will be followed up at 2 weeks, 6 weeks, 12 weeks, and 6 months.

Secondary

MeasureTime frame
To study the safety and tolerance of both the formulations of cyclosporine in dry eye diseaseTimepoint: All patients will be followed up at 2 weeks, 6 weeks, 12 weeks, and 6 months.

Countries

India

Contacts

Public ContactDr Amandeep kaur

Dr. Rajendra Prasad Centre for Ophthalmic Sciences

namrata.sharma@gmail.com9810856988

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026