Conditions: Vernal Keratoconjunctivitis
Keywords: vernal keratoconjunctivitis ciclosporin cyclosporine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 169
Healthy volunteers: no

Brief summary:
The objective of this study is to compare the efficacy of two different dosing regimen of NOVA22007 (1mg/ml ciclosporin/cyclosporine) eye drops, emulsion versus placebo (vehicle of the formulation) administered four times a day in patients with severe vernal keratoconjunctivitis after 4 months of treatment.

Detailed description:

Arms:
arm 1: One drop of ciclosporin (NOVA22007) 1 mg/ml 4 times a day as monotherapy (morning, noon, afternoon and evening). arm 2: One drop of ciclosporin (NOVA22007) 1 mg/ml twice a day and one drop of placebo twice a day (active study treatment morning and evening and placebo noon and afternoon) as monotherapy. arm 3: One drop of placebo 4 times a day as monotherapy (morning, noon, afternoon and evening).

Interventions: intervention 1: NOVA22007 ''Ciclosporin'' intervention 2: Placebo
Intervention descriptions: intervention 1: Sterile, ophthalmic cationic oil-in-water emulsion containing 1 mg/ml Ciclosporin. intervention 2: Sterile, drug-free, cationic ophthalmic oil-in-water emulsion containing 0 mg/ml Ciclosporin.

Protocol document: