TY - JOUR T1 - Evaluation of safety and efficacy of a new multipurpose disinfecting solution on silicone hydrogel contact lenses JO - Journal of Optometry T2 - AU - Pinto-Fraga,José AU - Blázquez Arauzo,Francisco AU - Urbano Rodríguez,Rubén AU - González-García,María J. SN - 18884296 M3 - 10.1016/j.optom.2014.07.004 DO - 10.1016/j.optom.2014.07.004 UR - https://www.journalofoptometry.org/en-evaluation-safety-efficacy-new-multipurpose-articulo-S1888429614000673 AB - PurposeTo evaluate the safety and efficacy of a new multipurpose disinfecting solution (MPDS) with a formulation that includes aloe vera on its composition. MethodsThis is a prospective, randomized, double-masked clinical trial with a crossover design that included seven examinations. Two different MPDSs, Avizor Alvera® (study solution) and All Clean Soft® (control solution), each were used for 1 month. Comfilcon A silicone hydrogel contact lenses were used during the trial. The main outcome variables were corneal staining and deposits on the surfaces of the contact lenses. Other parameters including ocular surface response, contact lens wettability, user satisfaction, and adverse events, were analyzed according to the International Organization for Standardization (ISO) 11980:2010 guidance for clinical investigation. ResultsTwenty subjects (10 women, 10 men) (mean age, 27.7±5.6 years; range, 20–41) were included. No differences between both MPDSs were found in the percentage of subjects with corneal staining >0 at day 30 (study: 35%, control: 50%; p=0.46); neither in the percentage of subjects with deposits on the surface of the contact lens >0 at day 30 (study: 26.32%, control: 52.63%; p=0.18). The study MPDS received higher rates in comfort (study: 8.14±1.09, control: 7.94±0.92; p=0.56) and satisfaction at day 30 (study: 8.63±0.91, control: 8.29±0.80; p=0.19), however the scores were not significantly different with the control MPDS. ConclusionsThe clinical trial showed that the study MPDS is safe, efficient, and has acceptable physiologic tolerance, according to the ISO 11980:2010 guidance for clinical investigation. ER -