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A Study Comparing Two Oral Medicines (Cyclosporine and Tofacitinib) for Safety and Effectiveness in Patients with Severe Vernal and Atopic Eye Allergy

Systemic Immunomodulation in Recalcitrant or Refractory Vernal and Atopic Keratoconjunctivitis: A Prospective Comparison of Efficacy and Safety of Oral Cyclosporine A Versus Oral Tofacitinib A Pilot Study - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/109476
Enrollment
20
Registered
2026-04-27
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

None listed

Interventions

Intervention1: Tofacitinib: we will study and compare clinical efficacy and safety of oral cyclosporine A versus oral Tofacitinib in recalcitrant/refractory vernal and atopic keratoconjunctivitis. Tof

Sponsors

Advance eye center post graduate institute of medical education and research institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Age: 8-35 years 2)Moderate-severe VKC/AKC (5-5-5 exacerbation scale) 3)Recalcitrant VKC/AKC (relapse within 1 months of topical/oral steroid) Refractory VKC/AKC (Steroid unresponsive /Steroid toxicity)

Exclusion criteria

Exclusion criteria: 1)Patients with ocular diseases other than AKC/VKC 2)Prior systemic immunosuppressant 3)Patients with systemic diseases other than allergic diseases 4)Hepatic/renal dysfunction 5)Pregnant/lactating women 6)Patients not willing to give consent for participation or follow-up 7)Patients with any form of coagulopathy

Design outcomes

Primary

MeasureTime frame
1)Change in total sign score from baseline at 12 weeks 2)Change in total symptom score from baseline at 12 weeksTimepoint: Patients will follow up at 2weeks, 1month and 3 months.

Secondary

MeasureTime frame
1)Change in individual sign score from baseline at 12 weeks 2)Change in quality-of-life score 3)Change in 5-5-5 exacerbation score of VKC/AKC 4)Number of acute episodes after initiation of treatment 5)Change in visual acuity from baseline at 12 weeks 6)Any associated systemic or ocular side effectsTimepoint: Patients will follow up at 2weeks, 1month and 3 months.

Countries

India

Contacts

Public ContactDr Amit Gupta

Post graduate institute of medical education and research

amitguptaeye@gmail.com9814286731

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026