Conditions: Conjunctivitis, Vernal
Keywords: vernal keratoconjunctivitis (VKC), eye, allergy, cyclosporin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 118
Healthy volunteers: no

Brief summary:
The primary objective of this study is:

* To assess the efficacy of Nova22007, a cyclosporine A (CsA), 0.05% and 0.1% versus vehicle in patients with vernal keratoconjunctivitis (VKC) after a 4-week treatment period.

The secondary objectives of this study are:

* To compare the safety and ocular tolerance of Nova22007 0.05% and 0.1%;
* To assess the long term safety and ocular tolerance of Nova22007 0.05% and 0.1%; and
* To assess the decrease in frequency of concomitant artificial tears use.

Detailed description:

Arms:
arm 1: four times daily arm 2: four times daily arm 3: administered four times daily

Interventions: intervention 1: Cyclosporine NOVA22007 0.05% intervention 2: Cyclosporine NOVA22007 0.1% intervention 3: Vehicle
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: