June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Topical Ciclosporin A 1 mg/mL Cationic Emulsion in the Treatment of Active Severe Vernal Keratoconjunctivitis (VKC) in Pediatric Patients: Results of the Phase III VEKTIS Study
Author Affiliations & Notes
  • Andrea Leonardi
    Department of Neuroscience, University of Padua, Padua, Italy
    Department of Ophthalmology, University of Padua, Padua, Italy
  • Serge Doan
    Bichat Hospital and Foundation A. de Rothschild, Paris, France
  • Mourad Amrane
    Santen SAS, Evry, France
  • Dahlia Ismail
    Santen SAS, Evry, France
  • Jesus Montero
    Universidad de Sevilla, Sevilla, Spain
  • VVL Narasimha Rao
    Department of Ophthalmology, Resapuvanipalem, Andhra Medical College/King George Hospital, Visakhapatnam, Andhra Pradesh, India
  • Janos Nemeth
    Department of Ophthalmology, Semmelweis University, Budapest, Hungary
  • Dominique Bremond-Gignac
    Hopital Universitaire Necker-Enfants Malades, Paris, France
  • Footnotes
    Commercial Relationships   Andrea Leonardi, Santen (C); Serge Doan, Alcon (C), Allergan (C), Bausch&Lomb (C), Horus (C), Santen (C), Thea (C); Mourad Amrane, Santen (E); Dahlia Ismail, Santen (E); Jesus Montero, None; VVL Narasimha Rao, None; Janos Nemeth, None; Dominique Bremond-Gignac, None
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 541. doi:
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      Andrea Leonardi, Serge Doan, Mourad Amrane, Dahlia Ismail, Jesus Montero, VVL Narasimha Rao, Janos Nemeth, Dominique Bremond-Gignac; Topical Ciclosporin A 1 mg/mL Cationic Emulsion in the Treatment of Active Severe Vernal Keratoconjunctivitis (VKC) in Pediatric Patients: Results of the Phase III VEKTIS Study. Invest. Ophthalmol. Vis. Sci. 2017;58(8):541.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Ciclosporin A cationic emulsion (CsA CE) for topical ocular use is an oil-in-water emulsion that can remain longer on the ocular surface, thereby optimizing its therapeutic effects. The VEKTIS study, a phase III, multicenter, double-masked, vehicle-controlled trial, evaluated the efficacy and tolerability of CsA CE 1 mg/mL eye drops for treating severe vernal keratoconjunctivitis (VKC) in pediatric patients.

Methods : 169 patients between 4 and 18 years of age who had severe VKC with severe keratitis were randomized to 4-month treatment with one of two active doses of CsA CE 1 mg/mL (high-dose [four times daily] or low-dose [twice daily]) or to the vehicle. This was followed by an 8-month safety follow-up period during which patients were re-randomized to one of the two active treatment arms. The primary endpoint (PE) was a mean composite score that reflected corneal fluorescein staining (CFS) as assessed by the modified Oxford scale, need for rescue medication, and occurrence of corneal ulceration during 4 months.

Results : The PE of superiority of active treatment over vehicle was met; the difference in the least-squares (LS) mean vs vehicle was statistically significant for both the high-dose group (0.76, p = 0.007) and the low-dose group (0.67, p = 0.010). Treatment effect was mainly driven by CFS score. A majority of the patients did not need rescue medication, and while the mean number of rescue medication courses was significantly different between the high-dose and vehicle groups (p = 0.010), it was only marginally different between the low-dose and vehicle groups (p = 0.055). The symptoms and quality of life also improved; outcomes remained stable over the 8-month follow-up. Overall, the proportions of patients with ≥1 adverse event were 58.3% and 50.0% in the high- and low-dose groups, respectively. The most frequently reported AEs in the high-dose group were instillation site pain, instillation site pruritus, cough, influenza, and ocular hyperemia.

Conclusions : Patients who received active doses (high and low doses) of CsA CE 1 mg/mL showed significant improvement in signs of VKC when compared with patients receiving the vehicle alone. Follow-up at 8 months suggested a good tolerability and efficacy profile, with maintenance of beneficial treatment effects.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

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