Anne-Nele Grzella1,2, Sabine Schleicher1, Kija Shah-Hosseini1, Anatoli Astvatsatourov3, Esther Raskopf2, Silke Allekotte2, Ralph Mösges4,5. 1. Institute of Medical Statistics and Computational Biology (IMSB), Faculty of Medicine, University of Cologne, Cologne, Germany. 2. CRI - Clinical Research International Ltd., Cologne, Germany. 3. Clinical Trials Center Cologne, Faculty of Medicine, University of Cologne, Cologne, Germany. 4. Institute of Medical Statistics and Computational Biology (IMSB), Faculty of Medicine, University of Cologne, Cologne, Germany, Ralph@Moesges.de. 5. CRI - Clinical Research International Ltd., Cologne, Germany, Ralph@Moesges.de.
Abstract
BACKGROUND: Liposomal eye spray (LS) has been introduced for the treatment of dry eye. Whether LS can also relieve symptoms due to allergic rhinoconjunctivitis (ARC) has not yet been sufficiently investigated. OBJECTIVES: The aim of this study was to assess the onset of action, the reduction of allergy symptoms, and the safety of LS - a nonpharmacological treatment option - compared with those of antihistamine eye drops (AD). METHODS: In this open, prospective, controlled, monocenter noninterventional study, adults with ARC received either LS or AD for the relief of eye irritation after a positive conjunctival provocation test (CPT). All patients completed a questionnaire before and after the CPT. Eye irritation was rated on a visual analogue scale (VAS) at 6 time points. Conjunctival redness was analyzed using objective digital analysis based on images taken during the study visit. RESULTS: Data were collected from 40 patients (20 per group). In both groups, 80% of patients perceived an onset of action within 0-2 min after application of LS or AD following the CPT. Relief of eye irritation (as determined by VAS) increased throughout the visit for both groups. In the digital analysis, the mean proportion of redness of the eye decreased from 10.3 to 7.0% for LS and from 10.4 to 6.5% for AD, with the largest difference observed 10 min after application (LS: 8.9%; AD: 6.0%; p = 0.094). CONCLUSIONS: LS is a nonpharmacological treatment option for ARC, showing no significant difference or relevant numerical inferiority to AD in any parameter studied. It was generally safe and well tolerated.
BACKGROUND: Liposomal eye spray (LS) has been introduced for the treatment of dry eye. Whether LS can also relieve symptoms due to allergic rhinoconjunctivitis (ARC) has not yet been sufficiently investigated. OBJECTIVES: The aim of this study was to assess the onset of action, the reduction of allergy symptoms, and the safety of LS - a nonpharmacological treatment option - compared with those of antihistamine eye drops (AD). METHODS: In this open, prospective, controlled, monocenter noninterventional study, adults with ARC received either LS or AD for the relief of eye irritation after a positive conjunctival provocation test (CPT). All patients completed a questionnaire before and after the CPT. Eye irritation was rated on a visual analogue scale (VAS) at 6 time points. Conjunctival redness was analyzed using objective digital analysis based on images taken during the study visit. RESULTS: Data were collected from 40 patients (20 per group). In both groups, 80% of patients perceived an onset of action within 0-2 min after application of LS or AD following the CPT. Relief of eye irritation (as determined by VAS) increased throughout the visit for both groups. In the digital analysis, the mean proportion of redness of the eye decreased from 10.3 to 7.0% for LS and from 10.4 to 6.5% for AD, with the largest difference observed 10 min after application (LS: 8.9%; AD: 6.0%; p = 0.094). CONCLUSIONS:LS is a nonpharmacological treatment option for ARC, showing no significant difference or relevant numerical inferiority to AD in any parameter studied. It was generally safe and well tolerated.
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Authors: G Roberts; O Pfaar; C A Akdis; I J Ansotegui; S R Durham; R Gerth van Wijk; S Halken; D Larenas-Linnemann; R Pawankar; C Pitsios; A Sheikh; M Worm; S Arasi; M A Calderon; C Cingi; S Dhami; J L Fauquert; E Hamelmann; P Hellings; L Jacobsen; E F Knol; S Y Lin; P Maggina; R Mösges; J N G Oude Elberink; G B Pajno; E A Pastorello; M Penagos; G Rotiroti; C B Schmidt-Weber; F Timmermans; O Tsilochristou; E-M Varga; J N Wilkinson; A Williams; L Zhang; I Agache; E Angier; M Fernandez-Rivas; M Jutel; S Lau; R van Ree; D Ryan; G J Sturm; A Muraro Journal: Allergy Date: 2017-10-30 Impact factor: 13.146