Abstract
Purpose: :
Vernal keratoconjunctivitis (VKC) is a chronic allergic disease in children. Although considered a seasonal disease (SD) most active in spring, recurrences occur into the fall with some patients developing perennial disease (PD). Based on the papillae, VKC can be subtyped as palpebral/tarsal, limbal or mixed. The influence of seasonality and VKC subtype, factors predictive of disease course and visual prognosis, were evaluated in VKC patients.
Methods: :
A double-masked, multicenter, randomized, parallel group study with a one month controlled phase and a three month extension phase was conducted. Patients with giant tarsal papillae or a mixed form of VKC and superficial keratitis were randomized in 3 groups: NOVA22007 0.05%, 0.1% or vehicle administered four times daily. Patients were classified historically as SD or PD. Efficacy was evaluated with an overall rating of subjective symptoms (BenEzra’s five point scale) and mean change from baseline in corneal fluorescein staining (CFS) on the Oxford scale at 1 month.
Results: :
Of 118 patients 28 (23.7%) presented with SD and 87 (73.7%) with a mixed (limbal and tarsal) subtype of VKC. In patients with SD and PD both active doses showed greater improvement in CFS compared to vehicle with the greatest improvement evident in those with PD (PD: -1.8 vs -1.6 vs -0.9; SD: -1.1 vs -1.6 vs -0.4 for 0.1% 0.05% and vehicle, respectively). Patients with PD showing marked or complete symptoms improvement were similar across treatment arms, whereas, in patients with SD both active doses showed greater symptoms improvements over the vehicle arm (PD: 58.6% vs 57.1% vs 57.1%; SD: 100% vs 81.8% vs 37.5% for 0.1% 0.05% and vehicle, respectively). Patients with mixed and tarsal VKC subtypes treated with either active dose showed greater improvement in CFS over vehicle with overall similar outcomes in both subtypes (mixed: -1.7 vs -1.5 vs -0.7; tarsal: -1.5 vs -2.0 vs -0.9 for 0.1% 0.05% and vehicle, respectively). While mixed subtype patients showing marked or complete symptoms improvement were similar across treatment arms, treated patients with tarsal VKC experienced greater symptoms improvement compared to vehicle (mixed: 53.6% vs 46.9% vs 49.7%; tarsal: 75% vs 71.4% vs 50.0%).
Conclusions: :
Overall treatment with NOVA22007 was most effective for improving keratitis in patients with active VKC. Whereas the seasonality and subtype were not observed to influence the keratitis treatment outcome, both factors seemed to influence the patient reported symptom outcome. In studies for new VKC treatments these findings would favor the use of an objective over a subjective primary endpoint assessment.
Clinical Trial: :
http://www.clinicaltrials.gov NCT00328653
Keywords: conjunctivitis • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • cyclosporine