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To compare the tacrolimus ophthalmic ointment of two different doses in non responding chronic conjunctivitis

Comparison of efficacy and safety of short-term low dose topical 0.03% Tacrolimus eye ointment versus topical 0.1% Tacrolimus eye ointment in patients with refractory bilateral Vernal keratoconjunctivitis. - TATA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/01/048952
Enrollment
60
Registered
2023-01-12
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

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

Conditions

Health Condition 1: H104- Chronic conjunctivitis

Interventions

Intervention1: Tacrolimus 0.03% eye ointment: Twice daily for 3 weeks and once daily for3 weeks Control Intervention1: Tacrolimus 0.1% eye ointment: Twice daily for 3 weeks and once daily for 3 weeks

Sponsors

KLE JGMM Medical College and Suchirayu Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.)Age > 14 years 2) Active bilateral Vernalkeratoconjunctivitis poorly responding to topical anti allergic agents and corticosteroids for more than two months of treatment

Exclusion criteria

Exclusion criteria: 1.)Patients with adenexal abnormalities, glaucoma, contact lens wearer ,active Corneal infection. 2.) Patients who have received immunosuppressive therapy in the past two months 3.) Ocular surgery in the past two months 4.)known hypersensitivity to tacrolimus eye ointment 5.) Pregnancy and lactation

Design outcomes

Primary

MeasureTime frame
Changes in mean scores of ocular symptoms(itching, redness, foreign body sensation and discharge) and signs ( conjunctival hyperaemia , limbal tranta dots and Corneal lesions)at 2 nd week, 4 th week, 6 th week and 8 th week.Timepoint: Two months

Secondary

MeasureTime frame
Subjective scoring of signs and symptoms at 2 nd week, 4 th week, 6 th week and 8 th week.Timepoint: Two months

Countries

India

Contacts

Public ContactDr Meghana Patil

JGMM Medical College and Suchirayu Hospital

drmeghana14@gmail.com07204351640

Outcome results

None listed

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