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Comparison of the efficacy between immunomodulator drugs in moderate to severe Dry eye

To compare the safety and efficacy of Topical Cyclosporin a (0.05%) with Topical Tacrolimus (0.03%), In patients of moderate to severe dry Eye

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/01/039630
Enrollment
150
Registered
2022-01-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

Health Condition 1: H188- Other specified disorders of cornea

Interventions

Intervention1: Topical Cyclosporin A (0.05%) Eye drop: 1 drop BD, topical for 6 months Control Intervention1: Topical Tacrolimus (0.03%) eye ointment: rice grain sized amount, OD, topical for 6 months

Sponsors

Regional Institute of Ophthalmology Kolkata
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with Dry eye symptoms such as Discomfort, Fatigue and Gritty sensation 2. Schirmer’s Test 3. TBUT 4. OSDI score > 15 5. Presence of Punctate staining in the Fluorescence staining of the cornea, NEI score > 3

Exclusion criteria

Exclusion criteria: 1. Previous Eye Surgery 2. Use of ocular medication other than tear substitutes. 3. Contact lens wearer 4. Glaucoma patients 5. Pregnant or Lactating Mothers 6. Presence of any microbial infection

Design outcomes

Primary

MeasureTime frame
To compare the improvement of OSDI score, schirmer I score, TBUT and NEI score in both groupTimepoint: 6 months

Secondary

MeasureTime frame
To assess the improvement the dry eye state of the symptomatic patients.Timepoint: 6 months;To assess the symptomatic improvement of dry eye disease patients with the above treatments.Timepoint: 6 months;To assess the visual outcome after the treatment.Timepoint: 6 months;To study prospectively the epidemiological scenario of dry eye in eastern India.Timepoint: 6 months

Countries

India

Contacts

Public ContactAshis Majumdar

Purulia Government Medical College and Hospital

docjayantadutta@rediffmail.com9433571337

Outcome results

None listed

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