Safety and Efficacy Clinical Trials for SYL1001, a Novel Short Interfering RNA for the Treatment of Dry Eye Disease

José Manuel Benitez-Del-Castillo, Javier Moreno-Montañés, Ignacio Jiménez-Alfaro, Francisco José Muñoz-Negrete, Krista Turman, Kadi Palumaa, Belén Sádaba, María Victoria González, Verónica Ruz, Beatriz Vargas, Covadonga Pañeda, Tamara Martínez (+2 others)
2016 Investigative Ophthalmology and Visual Science  
Citation: Benitez-Del-Castillo JM, Moreno-Montañés J, Jiménez-Alfaro I, et al. Safety and efficacy clinical trials for SYL1001, a novel short interfering RNA for the treatment of dry eye disease. Invest Ophthalmol Vis Sci. PURPOSE. To evaluate the efficacy and safety of SYL1001, a short interfering (si) RNA targeting the transient receptor potential cation channel subfamily V member 1 (TRPV1), for the treatment of dry eye disease (DED). METHODS. This study combines a phase I and two phase II
more » ... and two phase II clinical trials to test different doses of SYL1001 in a total of 156 healthy subjects and patients with DED. After 10 days of treatment, the primary efficacy endpoints were the effect on (1) the scoring in the Visual Analogue Scale (VAS) and Ocular Surface Disease Index (OSDI) questionnaires, and (2) ocular tolerance evaluated by corneal fluorescein staining and conjunctival hyperemia. Secondary endpoints included the assessment of systemic and local tolerance.
doi:10.1167/iovs.16-20303 pmid:27893109 fatcat:xbgb5lekpbfmhk5lu5fj6qyjwm