Efficacy and safety of dual-polymer hydroxypropyl guar- and hyaluronic acid-containing lubricant eyedrops for the management of dry-eye disease: a randomized double-masked clinical study
| Autor: | D.J. Galarreta, Stefanie Schmickler, Abayomi Ogundele, Marc Labetoulle, Michel Guillon, Daniel Böhringer, Christophe Baudouin |
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| Přispěvatelé: | AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre), Universidad de Valladolid [Valladolid] (UVa), University Hospital Freiburg, Institut de la Vision, Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts (CHNO), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Sorbonne Université - Faculté de Médecine (SU FM), Sorbonne Université (SU) |
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Sh groups
medicine.medical_specialty dry-eye disease medicine.medical_treatment Sodium hyaluronate hydroxypropyl guar 01 natural sciences Gastroenterology artificial tears dual polymer Clinical study 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine [SDV.SP.MED]Life Sciences [q-bio]/Pharmaceutical sciences/Medication Internal medicine Ophthalmology hyaluronic acid Hyaluronic acid Medicine In patient [SDV.MHEP.OS]Life Sciences [q-bio]/Human health and pathology/Sensory Organs Original Research Hydroxypropyl guar business.industry Clinical Ophthalmology 0104 chemical sciences 3. Good health 010404 medicinal & biomolecular chemistry Artificial tears chemistry 030221 ophthalmology & optometry business Ocular surface |
| Zdroj: | Clinical Ophthalmology (Auckland, N.Z.) Clinical ophthalmology Clinical ophthalmology, Dove medical press, 2018, Volume 12, pp.2499-2508. ⟨10.2147/OPTH.S177176⟩ |
| ISSN: | 1177-5483 1177-5467 |
| Popis: | Marc Labetoulle,1 Stefanie Schmickler,2 David Galarreta,3 Daniel Böhringer,4 Abayomi Ogundele,5 Michel Guillon,6 Christophe Baudouin7,8 1Ophtalmologie, Hôpital Bicêtre, APHP, South Paris Université, Kremlin-Bicêtre, Paris, France; 2Augen-Zentrum-Nordwest Augenpraxis, Ahaus, Germany; 3Hospital Clinico Universitario de Valladolid, Valladolid, Spain; 4Eye Center, University Hospital Freiburg, Freiburg, Germany; 5Novartis Pharmaceutical Corporation, Fort Worth, TX, USA; 6Ocular Technology Group, London, UK; 7Quinze-Vingts Hospital, DHU Sight Restore, University Versailles Saint Quentin en Yvelines, INSERM-DHOS CIC, Paris, France; 8Sorbonne Universités, UPMC Univ Paris 06, INSERM, CNRS, Institut de la Vision, Paris, France Background: An artificial-tear formulation containing the dual polymers hydroxypropyl guar (HPG) and hyaluronic acid (HA) is approved for the treatment of dry-eye disease (DED). Thepresent study compared the efficacy and safety of the HPG-HA dual-polymer formulation vs a sodium hyaluronate (SH)-containing artificial-tear formulation in patients with DED.Methods: In a prospective, 6-week, multicenter, double-masked, parallel-group study, patients with DED aged ≥18 years and total ocular surface staining (TOSS) score ≥4 and ≤9 were randomized (1:1) to receive either HPG-HA or SH four times a day for 42 days. Changes from baseline in TOSS (primary end point), impact of dry eye on everyday life (IDEEL) treatment-satisfaction scores (effectiveness and inconvenience), and tear-film breakup time (TFBUT) at day 42 were assessed using a fixed-sequence testing strategy. Noninferiority was assessed on the primary end point based on the upper limit of two-sided 95% CIs for mean treatment difference (HPG-HA or SH) |
| Databáze: | OpenAIRE |
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