Vernal Keratoconjunctivitis MedDRA version: 9.1 Level: SOC Classification code 10015919 Term: Eye disorders
Conditions
Interventions
Trade Name: PROGRAF*INFUS EV 10F 5MG/1ML
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: TACROLIMUS
Current Sponsor code: TCR
Concentration type: equal
Trade Name: SANDIMMUN*INFUS 10F
Sponsors
AZIENDA OSPEDALIERA MEYER
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Active VKC - At least 6 months from the start of VKC - Objective score of 7 points or more - No substantial decrease in sign and symptoms of VKC after at least 15 days of topical treatment with cyclosporine Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - age < 2 years - Immunodeficiency - Neoplasms - Chronic infectious diseases - Active corneal ulcer(s)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The major aim of the study is to verify efficacy and long term safety of Tacrolimus, administered topically, compared to Cyclosporine in severe VKC;Secondary Objective: verifying improvement of subjective symptoms and Quality of Life of patients and their parents;Primary end point(s): Efficacy End Point : evaluation of efficacy of tacrolimus eye drops when compared with cyclosporine eyedrops in patients with severe VKC not responders to cyclosporine eye drops. Safety End Point : evaluation of long safety of tacrolimus eyedrops in severe Vernal Keratoconjunctivitis | — |
Countries
Italy
Outcome results
None listed