José Pinto-Fraga1, Francisco Blázquez Arauzo2, Rubén Urbano Rodríguez3, María J González-García4. 1. Instituto de Oftalmobiología Aplicada, Universidad de Valladolid, Valladolid, Spain; CIBER-BNN, Valladolid, Spain. 2. Instituto de Oftalmobiología Aplicada, Universidad de Valladolid, Valladolid, Spain. 3. Research and Research and Development Department, Avizor S.A., Madrid, Spain. 4. Instituto de Oftalmobiología Aplicada, Universidad de Valladolid, Valladolid, Spain; CIBER-BNN, Valladolid, Spain. Electronic address: aluche@ioba.med.uva.es.
Abstract
PURPOSE: To evaluate the safety and efficacy of a new multipurpose disinfecting solution (MPDS) with a formulation that includes aloe vera on its composition. METHODS: This 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. RESULTS:Twenty 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. CONCLUSIONS: The 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.
RCT Entities:
PURPOSE: To evaluate the safety and efficacy of a new multipurpose disinfecting solution (MPDS) with a formulation that includes aloe vera on its composition. METHODS: This 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. RESULTS: Twenty 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. CONCLUSIONS: The 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.
Authors: Zhenjun Zhao; Nicole A Carnt; Yulina Aliwarga; Xiaojia Wei; Thomas Naduvilath; Qian Garrett; John Korth; Mark D P Willcox Journal: Optom Vis Sci Date: 2009-03 Impact factor: 1.973