Topical cyclosporine A cationic ophthalmic emulsion in paediatric vernal keratoconjunctivitis: pooled analysis of randomised NOVATIVE and VEKTIS trials.

ABSTRACT:

Background/objectives

Cyclosporine A cationic ophthalmic emulsion (CsA CE) was evaluated in paediatric and adolescent patients with vernal keratoconjunctivitis (VKC) in the NOVATIVE (NCT00328653) and VEKTIS (NCT01751126) trials. The similarity of these studies permitted pooled assessment of the effect of CsA CE on corneal damage as well as safety and tolerability.

Subjects/methods

Pooled outcomes were assessed for the first 28 days of treatment. In NOVATIVE, 118 patients were randomised to 4 times daily (QID) CsA CE 0.05%, 0.1%, or vehicle eye drops. In VEKTIS, 169 patients were randomised to CsA CE 0.1% QID or twice daily (BID) or vehicle. For these analyses, treatment groups comprised: (1) pooled CsA CE 0.1% QID arms (high-dose; n = 96); (2) pooled CsA CE 0.05% QID arm fro

SUBMITTER: Leonardi A 

PROVIDER: S-EPMC10366270 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature