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Mourad Amrane, Dominique Bremond-Gignac, Christopher Baudouin, Andrea Leonardi, Maeva Deniaud, Ronald Buggage; A Multicenter, Double-masked, Randomized, Parallel Group, Controlled Trial Of Efficacy And Tolerance Of NOVA22007 (Cyclosporine Cationic Emulsion) Versus Vehicle In Patients With Vernal Keratoconjunctivitis. Invest. Ophthalmol. Vis. Sci. 2011;52(14):6415.
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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.
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.
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.
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.
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