Ocular cicatricial pemphigoid (OCP) MedDRA version: 9.1 Level: LLT Classification code 10010746 Term: Conjunctivitis chronic
Conditions
Interventions
Trade Name: RESTASIS
Pharmaceutical Form: Eye drops, suspension
INN or Proposed INN: Cyclosporine
Concentration unit: % percent
Concentration type: equal
Concentration number: .05-
Pharmaceutical form
Sponsors
UNIVERSITA' CAMPUS BIOMEDICO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) diagnosis of cicatricial pemphigoid with ocular involvement observed and confirmed by direct immunofluorence at conjunctival biopsy 2) a minimum of 3 months of follow-up before the inclusion in the study 3) presence of first-line conventional immunosuppressive therapy and artificial tears at the time of enrolment 4) evidence of at least one relapse of conjunctival inflammation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with severe inflammatory disease not responding to the described first-line systemic therapy and requiring systemic Cyclophosphamide plus high doses of Prednisolone at the time of enrolment, will be not included. Patients with corneal ulceration, patients affected by infective ocular diseases, patients subjected to ocular surgery in the preceding 6 months, patients under ocular treatments or patients on systemic treatments that can influence the immunosuppressive therapy, or patients enrolled in experimental trials in the preceding 3 months shall be excluded. In addition, patients in pregnancy or in breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: evaluate the efficacy of Cyclosporine A 0.05% eye drop treatment in controlling conjunctival inflammation in patients with OCP, in addition to conventional immunosuppressive systemic therapy (CIST).;Secondary Objective: compare progression of conjunctival fibrosis (Foster Classification), visual acuity, ocular surface changes, quality of life, tear function and conjunctival epithelial cytological changes between the CyA eyedrop treated group and the placebo treated group of patients.;Primary end point(s): evaluate the percentage of patients showing more than 2 relapses of conjunctival inflammation during the 2 years of treatment. | — |
Countries
Italy
Outcome results
None listed