Double-Masked Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Vehicle in Pediatric Patients With Active Severe Vernal Keratoconjunctivitis

Inclusion Criteria: * Males or females from 4 to less than 18 years of age. * History of at least one recurrence of vernal keratoconjunctivitis (VKC) in the past year prior to enrolment. * Patients not receiving any treatment for an established and active VKC; or patients already receiving treatment for their VKC provided treatment is stopped according to the wash-out period specified in the exclusion criteria. * Active severe VKC consistent with grade 3 or 4 of Bonini scale (Bonini 2007) with severe keratitis (grade 4 or 5 on the modified Oxford scale). * Mean score of 4 subjective symptoms (photophobia, tearing, itching and mucous discharge) ≥ 60 mm using a 100 mm Visual Analogue Scale (where "0" means no symptom and "100" means the worst that have been ever experienced). Exclusion Criteria: * Any relevant ocular anomaly other than VKC interfering with the ocular surface including trauma, post radiation keratitis, severe blepharitis, rosacea, corneal ulcer etc. * Abnormal lid anatomy, abnormalities of the nasolacrimal drainage system or blinking function in either eye. * Active herpes keratitis or history of ocular herpes. * Active ocular infection (viral, bacterial, fungal, protozoal). * Any ocular diseases other than VKC requiring topical ocular treatment during the course of the study. * Contact lenses wear during the study. * Topical and/or systemic use of corticosteroids within one week prior to enrolment. * Topical ciclosporin (e.g. Restasis®), tacrolimus or siroli…