April 2011
Volume 52, Issue 14
ARVO Annual Meeting Abstract  |   April 2011
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
Author Affiliations & Notes
  • Mourad Amrane
    Novagali Pharma, Evry, France
  • Dominique Bremond-Gignac
    Ophthalmology, St Victor Center, CHU Amiens, University Picardie, Amiens, France
  • Christopher Baudouin
    Ophthalmology, Quinze-Vingts Hospital, Paris, France
  • Andrea Leonardi
    Dept. of Neuroscience, Ophthalmology Uni, University of Padova, Padova, Italy
  • Maeva Deniaud
    Soladis, Lyon, France
  • Ronald Buggage
    Novagali Pharma, Evry, France
  • Footnotes
    Commercial Relationships  Mourad Amrane, Novagali Pharma (E); Dominique Bremond-Gignac, None; Christopher Baudouin, Novagali Pharma (C); Andrea Leonardi, Novagali Pharma (C); Maeva Deniaud, Novagali Pharma (C); Ronald Buggage, Novagali Pharma (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science April 2011, Vol.52, 6415. doi:
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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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      © ARVO (1962-2015); The Authors (2016-present)

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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 

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