The discordance between objective signs and giant papillae improvement in patients with vernal keratoconjunctivitis (VKC) participating in a randomized, controlled, clinical trial

Abstract

AbstractPurpose Resolution of papillae is a desirable objective in the management of tarsal VKC. The effect of Vekacia®, an unpreserved cyclosporine cationic emulsion, was evaluated in children with active VKC presenting with giant papillae and keratitis at enrollment.Methods 118 VKC patients were randomized to Vekacia® 0.05%, 0.1%, or vehicle QID. The primary criterion was subjective symptom improvement. Objective signs (giant papillae, conjunctival hyperemia, discharge, chemosis, limbal infiltrates and corneal epithelial disease) were assessed as secondary endpoint.Results At Day 28, patient subjective symptoms improved in all groups without statistically significant difference between groups. Among the objective signs, except for papillae, clinically significant improvements were observed: absence of the sign ranged from 20.5% to 72% in both active groups and from 16.7% to 41.2% for vehicle group, depending of the sign. For papillae, only 4 patients experienced total clearing (2.8%, 2.6% and 6.6% in vehicle, 0.05% and 0.1% CsA groups respectively). Clinically and statistically significant differences in keratitis (CFS mean change) over vehicle were observed at Day 28 in Vekacia® treated patients (0.05%, p=0.003; 0.1% p=0.014).Conclusion Corneal involvement in VKC is a sight‐threatening complication. Improvement in keratitis, a key element in the management of the active VKC was not associated with complete resolution of the papillae. Therefore, among the signs of the disease, papillae appear to be the least helpful sign to follow VKC improvement. Commercial interest