Safety and Efficacy of an Artificial Tear Containing 0.3% Hyaluronic Acid in the Management of Moderate-to-Severe Dry Eye Disease.

PURPOSE: To evaluate the safety and efficacy of a new 0.3% hyaluronic acid artificial tear compared with 0.9% saline solution (0.9% NaCl) in moderate-to-severe dry eye patients after 1 month's use. METHODS: A total of 16 patients with moderate-to-severe dry eye were included in this crossover study. After a 1-week washout period, patients used the experimental (Visaid 0.3%) or control solution (0.9% NaCl), selected randomly, applying three to eight drops daily for a month. After another washout period, patients used the other solution in the same way. Percentage of change (ΔY) was calculated and analyzed for (1) safety variables: visual acuity, intraocular pressure, and ophthalmoscopy evaluation; (2) efficacy variable: Ocular Surface Disease Index (OSDI) questionnaire; and (3) secondary variables: biomicroscopy findings, fluorescein corneal staining, lissamine green conjunctival staining, tear breakup time (TBUT), contrast sensitivity, Schirmer test, and subject satisfaction. RESULTS: There were no significant differences in the safety parameters for either solution. After using Visaid 0.3%, patients showed significant improvements in OSDI score (ΔY: -9.66%±10.90), tarsal hyperemia (ΔY: -16.67%±27.89), corneal staining extension (ΔY: -34.90%±42.41), TBUT (ΔY: 13.98%±26.19), and subjective satisfaction (ΔY: 38.06%±47.06). When using 0.9% NaCl, Schirmer test results were significantly worse (ΔY: -11.47%±19.27). A significant difference between the 2 solutions was found in TBUT (ΔY: 13.98%±26.19 vs. 10.15%±42.34, respectively; P=0.0214). CONCLUSION: Visaid 0.3% is a safe product with some benefits over 0.9% NaCl in reducing ocular symptoms and improving some ocular signs in patients with moderate-to-severe dry eye.

Efficacy and Safety of 0.2% Hyaluronic Acid in the Management of Dry Eye Disease.

OBJECTIVES: To evaluate the safety and efficacy of a new artificial tear containing 0.2% hyaluronic acid, as compared with 0.9% saline solution, in mild dry eye patients after 1-month use in a crossover study design with washout periods. METHODS: Overall, 16 mild dry eye patients were included. After a week of washout, every patient used the experimental product (Visaid 0.2%) and the control product (0.9% saline solution), each for a month (3-8 drops daily). Both products were preservative free. The percentage change for the following variables were calculated and analyzed: Ocular Surface Disease Index (OSDI) questionnaire, visual acuity, intraocular pressure, ophthalmoscopy evaluation, biomicroscopy findings, fluorescein corneal staining and lissamine green conjunctival staining, tear breakup time, contrast sensitivity, Schirmer's test, and subject satisfaction. RESULTS: Patients reported an improvement (a significant decrease of -19.5%±27.5%) in OSDI scores after using Visaid 0.2% and a worsening (a significant increase of 19.2%±32.4%) after using 0.9% saline solution; the difference was significant (P=0.0087, Student's t test). Significant changes (P≤0.04, Wilcoxon's test) were found comparing Visaid 0.2% with saline solution for bulbar hyperemia (-39.1%±50.8% vs. 7.8%±12.0%, respectively), corneal staining (-26.0%±53.0% vs. 36.5%±73.3%), conjunctival staining (-54.7%±53.4% vs. -7.8%±47.2%), and subjective satisfaction (26.8%±28.5% vs. -13.3%±22.5%). There were no significant differences in the safety parameters for either solution. CONCLUSION: This clinical trial demonstrates the safety of Visaid 0.2% and its clear benefit over 0.9% saline solution.

Evaluation of safety and efficacy of a new multipurpose disinfecting solution on silicone hydrogel contact lenses.

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.

Evaluation of safety and efficacy of a new multipurpose disinfecting solution on silicone hydrogel contact lenses / Evaluación de la seguridad y eficacia de una nueva solución multipropósito en lentes de contacto de hidrogel de silicona

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 clinicaltrial 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 (AU)

Objetivo: Evaluar la seguridad y la eficacia de una nueva solución única desinfectante (MPDS), con una formulación que incluye aloe vera en su composición. Métodos: El estudio consistió en un ensayo clínico prospectivo, aleatorio y de doble ciego, con un diseño cruzado que incluyó siete exámenes. Se utilizaron durante un mes dos MPDS diferentes, Avizor Alvera® (solución en estudio) y All Clean Soft® (solución de control). Durante el ensayo se utilizaron lentes de contacto de hidrogel de silicona Comfilcon A. Las principales variables evaluadas fueron la tinción corneal y los depósitos sobre la superficie de las lentes de contacto. Se analizaron otros parámetros, que incluían la respuesta de la superficie ocular, la humectabilidad de las lentes de contacto, y los eventos adversos, de acuerdo con la normativa 11980:2010 de la Organización Internacional de Normalización (ISO) para investigación clínica. Resultados: El estudio incluyó a veinte sujetos (10 mujeres, 10 hombres) (edad media, 27,7 ± 5,6 años; rango, 20-41). No se hallaron diferencias entre ambas MPDS en cuanto al porcentaje de sujetos con tinción corneal > 0 al mes (estudio: 35%, control: 50%; p = 0,46), ni el porcentaje de sujetos con depósitos en la superficie de las lentes de contacto > 0 al mes (estudio: 26,32%, control: 52,63%; p = 0,18). La MPDS en estudio obtuvo valoraciones superiores en cuanto a confort (estudio: 8,14 ± 1,09, control: 7,94 ± 0,92; p = 0,56) y satisfacción (estudio: 8,63 ± 0,91, control: 8,29 ± 0,80; p = 0,19); sin embargo, las puntuaciones no fueron significativamente diferentes en relación a la MPDS de control. Conclusiones: El ensayo clínico reflejó que la MPDS en estudio es segura y eficaz, mostrando una tolerancia fisiológica aceptable, de acuerdo con la normativa ISO 11980:2010 para investigación clínica (AU)