Abstract
Purpose: :
Vernal keratoconjunctivitis (VKC) is an allergic disease that may persist throughout the year. The anti-inflammatory effect of a topical cyclosporine cationic emulsion (NOVA22007) was evaluated in VKC patients.
Methods: :
A double-masked, multicenter, randomized, parallel group study with a one month controlled phase followed by a three month extension phase was conducted. Patients with giant 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. The primary efficacy criterion, the overall rating of subjective symptoms (BenEzra’s five point scale), was measured at weeks 1, 2 and 4 (the primary efficacy endpoint assessment). Corneal fluorescein staining (CFS), the overall rating of objective signs and the investigator assessed global response to treatment were evaluated as secondary efficacy endpoints.
Results: :
118 patients (median age 8.8 years) were enrolled in the study with 23.7% presenting with seasonal and 73.7% with a mixed form (limbal and tarsal) of VKC. Subjective symptoms were improved in each group and reached statistical significance for the NOVA22007 0.1% compared to vehicle at weeks 1 and 2 (p<0.05, respectively). At week 4 there was no difference between the NOVA22007 groups and the vehicle emulsion for the primary efficacy endpoint. Both doses of NOVA22007 showed a clinically and statistically significant improvement in CFS on the Oxford scale (delta=0.8, p<0.02) and the overall rating of objective signs (p<0.05) compared to vehicle at 4 weeks. In both NOVA22007 doses the global response to treatment was assessed to be greater than the emulsion vehicle (79.5%, 86.5% and 55% in the 0.05%, 0.1% and vehicle groups, respectively). During the first month of treatment no serious adverse events were reported for either NOVA2207 dose while 3 patients in the vehicle group developed corneal ulcers.
Conclusions: :
VKC is a chronic, severe condition in children that may result in visual impairment. NOVA22007 was found to be a safe and effective treatment, particularly on keratitis, in patients with VKC with the potential to prevent the progression to sight threatening visual complications.
Clinical Trial: :
http://www.clinicaltrials.gov NCT00328653
Keywords: conjunctivitis • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • cyclosporine