Physicochemical and microbiological stability study of two new preservative-free methylprednisolone eye drops. / Estudio de estabilidad fisicoquímica y microbiológica de dos nuevos colirios de metilprednisolona sin conservantes.

OBJECTIVE: To study the physicochemical and microbiological stability over 90 days of two preservative-free methylprednisolone sodium succinate (MTPSS) 1 mg/ml and 10 mg/ml eye drops for use in ocular pathologies such as Sjögren's syndrome and dry eye syndrome. METHOD: The two eye drops were prepared from injectable MTPSS (Solu-moderin® and Urbason®), water for injection and normal saline solution. In accordance with ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) guidelines, they were then stored in triplicate under refrigerated conditions (5 ±3 °C), at room temperature (25 ± 2 °C), and at 40 °C (±2 °C). In accordance with the USP (United States Pharmacopeia), physicochemical controls of the active ingredient content were carried out by HPLC-UV (High Performance Liquid Chromatography with Ultraviolet detection), together with controls of pH, osmolality, and visual examination. Microbiological sterility was also tested under refrigerated conditions up to 30 days in open containers and up to 90 days in closed ones. RESULTS: The eye drops stored at 5 °C were the most stable; in the 1 mg/ml eye drops, degradation of the drug fell below 90% from day 21, and in the 10 mg/ml eye drops, from day 42. pH change did not vary by ≥1 unit in formulations stored at 5 °C, unlike the other formulations. Changes in osmolality did not exceed 5% on day 90 in any storage conditions. Samples of non refrigerate eye drops at 10 mg/ml, presented a white precipitate from day 14 and 28 respectively. Non-refrigerated 1 mg/ml eye drops presented suspended particles on day 90. There were no color changes. Microbiological analysis showed that sterility was maintained for over 90 days in the closed containers, although microbial contamination was detected from day 21 in the open containers. CONCLUSIONS: 1 mg/ml MTPSS eye drops show physicochemical and microbiological stability for 21 days under refrigeration, compared to 42 days for 10 mg/ml eye drops stored under the same conditions. However, since they do not include preservatives in their composition, they should not be used for more than 7 days after opening.

Comparison of nanoemulsion and non-emollient artificial tears on tear lipid layer thickness and symptoms.

PURPOSE: Dry eye disease (DED) is often managed with over-the-counter eye drops. This study evaluated the diurnal effects of a single drop of two ocular lubricants (nanoemulsion vs. non-emollient) on tear film lipid layer thickness (LLT) and symptoms of ocular dryness. Subjects were also assessed after 1 month of nanoemulsion eye drop use. METHODS: Part 1 was a cross-over comparison of a nanoemulsion and a non-emollient eye drop. LLT and dry eye symptoms were measured at baseline and at 15min, 1h, 2h, 4h and 6h after instillation of each drop. Part 2 was a 1-month observational study assessing LLT and symptoms after 30-day use of the nanoemulsion drop four times daily (qid). RESULTS: Total of 20 subjects completed the study (mean age=45.6±7.9, 15 female). Part 1 found a significant increase in average LLT 15min after nanoemulsion drop instillation in the overall and inferior third of the tear film for subjects with baseline LLT values <50nm. Average LLT values did not increase after use of the non-emollient. Symptoms of dryness improved up to 6h following instillation of both drops. Part 2 results found that using the nanoemulsion eye drop for 1 month improved symptoms reported on symptom surveys. CONCLUSION: Nanoemulsion eye drop use increased average LLT in subjects with low baseline levels. Statistically and clinically significant improvement in symptoms were found on symptom surveys after qid-use (four times a day) of the nanoemulsion drop. Results suggest that a nanoemulsion eye drop can benefit subjects with dry eye symptoms.

Validation of nursing outcome indicators of the nursing outcomes classification: dry eye severity / Validación de indicadores del resultado de enfermería de la Nursing Outcomes classification: gravedad del ojo seco / Validação de indicadores do resultado de enfermagem da Nursing Outcomes classification: gravidade do olho seco

ABSTRACT Objective: To validate the content of the indicators of the nursing outcome Dry eye severity, of the Nursing Outcomes Classification, in adult patients admitted to the intensive care unit. Methods: Methodological study of content validity, developed in two stages: the first, consisting of 23 specialists; and the second, of a consensus group formed by ten nurses. For analyzing the data in the first stage, we used the content validity index and binomial test for each indicator; in the second stage, the discussions of each meeting were transcripted, and the indicators that achieved 100% consensus were validated. Results: Of the 14 indicators evaluated by the specialists, 7 presented a cut-off point below 0.80, but did not show statistical significance in the binomial test. In the consensus group's validation, six indicators were reformulated. Conclusion: This study considered the 14 indicators valid for evaluating patients admitted to the intensive care unit.

RESUMEN Objetivo: Validar el contenido de los indicadores del resultado de enfermería Gravedad del ojo seco, de la Nursing Outcomes Classification, en pacientes adultos internados en unidad de terapia intensiva. Métodos: Estudio metodológico de validación de contenido, desarrollado en dos etapas: la primera, compuesta por 23 especialistas; y la segunda, por un consenso en equipo formado por 10 enfermeros. Para análisis de los datos de la primera etapa, ocurrió transcripción de las discusiones de cada encuentro, y los indicadores que obtuvieron consenso 100% han sido validados. Resultados: De los 14 indicadores evaluados por los especialistas, 7 presentaron puente de cohorte inferior a 0,80, pero no evidenciaron significación estadística por él es binominal. En la validación por consenso en equipo, seis indicadores han sido reformulados. Conclusión: Los 14 indicadores han sido considerados válidos para ser utilizados en la evaluación de pacientes internados en unidad de terapia.

RESUMO Objetivo: Validar o conteúdo dos indicadores do resultado de enfermagem Gravidade do olho seco, da Nursing Outcomes Classification, em pacientes adultos internados em unidade de terapia intensiva. Métodos: Estudo metodológico de validação de conteúdo, desenvolvido em duas etapas: a primeira, composta por 23 especialistas; e a segunda, por um grupo-consenso formado por 10 enfermeiros. Para análise dos dados da primeira etapa, utilizou-se o índice de validade de conteúdo e teste binominal para cada indicador; na segunda etapa, ocorreu transcrição das discussões de cada encontro, e os indicadores que obtiveram consenso 100% foram validados. Resultados: Dos 14 indicadores avaliados pelos especialistas, 7 apresentaram ponte de corte inferior a 0,80, mas não evidenciaram significância estatística pelo teste binomial. Na validação por grupo-consenso, seis indicadores foram reformulados. Conclusão: Os 14 indicadores foram considerados válidos para serem utilizados na avaliação de pacientes internados em unidade de terapia intensiva.

Características dos pacientes com ressecamento ocular internados em unidade de terapia intensiva / Pacientes con sequedad ocular internados en unidad de terapia intensiva / Patients with dry eye admitted to an intensive care unit

RESUMO Objetivo: identificar características clínicas e sociodemográficas dos pacientes com ressecamento ocular internados em Unidade de Terapia Intensiva. Método: estudo quantitativo, observacional descritivo, realizado em hospital universitário no período de janeiro a junho de 2016, com instrumento composto por dados sociodemográficos e clínicos relacionados ao ressecamento ocular. Após inferência diagnóstica obteve-se amostra de 108 pacientes. Foram realizadas as análises descritivas, medidas de associação e razão de prevalência por meio de pacote estatístico. Resultados: constatou-se predomínio do sexo masculino com 58 (53,7%) pacientes, idade média 57 anos, 61 (56,6%) com hipertensão arterial, 84 (77,8%) com fechamento palpebral completo em olho direito e 80 (74,1%) esquerdo, 44 (40,7%) com hiperemiano olho direito e 41 (38%) esquerdo. Teste de Schirmer identificou volumetria insuficiente, mediana de 3 milímetros no olho direito e 4 milímetros no esquerdo. Conclusão: identificou-se informações relevantes para caracterização dos pacientes com ressecamento ocular, predição do fenômeno e consequente assistência qualificada.

RESUMEN Objetivo: identificar características clínicas, sociales y demográficas de los pacientes con sequedad ocular internados en Unidad de Terapia Intensiva. Método: estudio cuantitativo, observacional descriptivo, realizado en hospital universitario en el periodo de enero a junio de 2016, con instrumento compuesto por datos socio demográficos y clínicos asociados a la sequedad ocular. Tras la inferencia diagnóstica, se obtuvo muestra de 108 pacientes. Se realizaron análisis descriptivos, medidas de asociación y razón de prevalencia por medio de paquete estadístico. Resultados: se constató predominio del sexo masculino con 58 (53,7%) pacientes, edad media 57 años, 61 (56,6%) con hipertensión arterial, 84 (77,8%) con cerramiento palpebral completo en ojo derecho y 80 (74,1%) izquierdo, 44 (40,7%) con hiperemia en el ojo derecho y 41 (38%) izquierdo. Test de Schirmer identificó volumetría insuficiente, mediana de 3 milímetros en el ojo derecho y 4 milímetros en el izquierdo. Conclusión: se identificaron informaciones relevantes para caracterización de los pacientes con sequedad ocular, predicción del fenómeno y consecuente asistencia cualificada.

ABSTRACT Objective: to identify clinical and sociodemographic characteristics of patients with dry eye admitted to an intensive care unit. Method: observational and descriptive study with a quantitative approach conducted in a university hospital from January to June 2016, through the use of a form with questions on sociodemograpic characteristics and clinical data related to dry eye. After diagnostic inference, a sample of 108 patients was obtained. Descriptive analyzes, association measures and prevalence ratios were performed with the use of a statistical package. Results: there was a prevalence of male patients (53.7%), mean age of 57 years; 61 (56.6%) with hypertension; 84 (77.8%) with complete closure of the eyelid in the right eye and 80 (74.1%) with complete eyelid closure in the left eye; 44 (40.7%) with right eye hyperemia and 41 (38%) with left eye hyperemia. Schirmer test detected a reduced tear volume, median of 3 mm in the right eye and 4 mm in the left eye. Conclusion: Relevant information for the characterization of patients with dry eye, prediction of the phenomenon and delivery of proper care was identified.

The potential role of neuropathic mechanisms in dry eye syndromes.

Dry eye syndromes can involve both nociceptive and neuropathic symptoms. Nociceptive symptoms are the normal physiological responses to noxious stimuli. Neuropathic symptoms are caused by a lesion or disease of the somatosensory nervous system and can be the result of hypersensitisation of peripheral or central corneal and conjunctival somatosensory nerves. For example, inflammation could induce neuroplastic peripheral sensitisation of the ocular surface or lid wiper and exacerbate nociceptive symptoms. Neuropathic symptoms may explain the incommensurate relation between signs and symptoms in some dry eye syndromes although absence of signs of a dry eye syndrome may also be a consequence of inappropriate methods used when examining for them. Involvement of neuropathic mechanisms may also help explain dry eye symptoms which occur in association with reduced corneal sensitivity. This review includes a discussion of the potential for ocular symptoms involving neuropathic mechanisms to contribute to psychosocial problems such as depression, stress, anxiety and sleep disorders as well as for these types of psychosocial problems to contribute to neuropathic mechanisms and dry eye syndromes. Failure to consider the possibility that neuropathic mechanisms can contribute to dry eye syndromes may reduce accuracy of diagnosis and the suitability of treatment provided. Dry eye symptoms in the absence of commensurate evidence of tear dysfunction, and unsatisfactory response to tear dysfunction therapies should prompt consideration of neuropathic mechanisms being involved. Symptoms which persist after local anaesthetic instillation are more likely to be neuropathic in origin. Reducing inflammation may help limit any associated neuroplastic hypersensitivity.