Immediate Impact on Tear Osmolarity Following the Application of Different Ocular Lubricants in Patients Experiencing Moderate Dry Eye Symptoms.

PURPOSE: This study addresses the growing concern of Dry Eye Disease (DED), which has become increasingly prevalent due to modern lifestyles characterized by prolonged screen usage, global warming, polypharmacy, and extended life expectancy. METHODS: Grounded in the Dry Eye Workshop II (DEWSII) diagnosis framework, the study focuses on DED as a multifactorial condition affecting the ocular surface's tear film homeostasis. The study evaluates the short-term impact of 5 commercially available ocular lubricants on disrupting the hyperosmolar environment and determine whether these lubricants can offer potential treatment benefits for DED. RESULTS: Conducted on 300 eyes (from 150 patients) with 5 preservative-free lubricants compared to a control group, the study reveals that all lubricants effectively reduced tear film osmolarity within 15 minutes of application. Notably, the control group exhibited an increase in average osmolarity (+0.98 mOsm/L) without lubricant use. Siccafluid demonstrated the most substantial osmolarity reduction after 15 minutes, with an average decrease of 11.54 mOsm/L. Statistical significance was observed for Siccafluid, Optive Fusion unique dose (UD), and Systane Ultra UD, while Hyabak and Freegen preservative free (PF) showed lower significance. CONCLUSIONS: Emphasizing the importance of disrupting the hyperosmolar environment to break the cycle of inflammation, the study concludes that ocular lubricants, at least as an immediate post-application effect, can interrupt this cycle and improve the hyperosmolar environment of the ocular surface.

Autologous serum compared to artificial tear drops for dry eye disease. / Suero autólogo comparado con lágrimas artificiales para ojo seco.

INTRODUCTION: Dry eye is one of the most common ocular surface disorders. Although artificial tear drops therapy is the most widely used treatment, it has recently been suggested that autologous serum could be a beneficial alternative treatment for this disorder, but its use is controversial. METHODS: We searched in Epistemonikos, the largest database of systematic reviews in health, which is maintained by screening multiple information sources, including MEDLINE/PubMed, EMBASE, Cochrane, among others. We extracted data from the systematic reviews, reanalyzed data of primary studies, conducted a meta-analysis and generated a summary of findings table using the GRADE approach. RESULTS AND CONCLUSIONS: We identified six systematic reviews, including seven primary studies overall, of which all were randomized trials. We concluded that autologous serum treatment might not lead to adverse effects compared to artificial teardrops, but the certainty of the evidence is low. On the other hand, we are uncertain whether autologous serum therapy improves the quality of life, severity of the pathology, pain or the corneal epitheliopathy grade compared to artificial tear drops as the certainty of the evidence has been assessed as very low.

INTRODUCCIÓN: El ojo seco es una de las patologías oculares más frecuentes. Si bien el tratamiento más utilizado es el uso de lágrimas artificiales, se ha planteado el uso de suero autólogo como una alternativa terapéutica beneficiosa para pacientes con esta condición. Sin embargo, su uso es controvertido. MÉTODOS: Realizamos una búsqueda en Epistemonikos, la mayor base de datos de revisiones sistemáticas en salud, la cual es mantenida mediante el cribado de múltiples fuentes de información, incluyendo MEDLINE/PubMed, EMBASE, Cochrane, entre otras. Extrajimos los datos desde las revisiones identificadas, analizamos los datos de los estudios primarios, realizamos un metanálisis y preparamos una tabla de resumen de los resultados utilizando el método Grading of Recommendations Assessment, Development and Evaluation, GRADE. RESULTADOS Y CONCLUSIONES: Identificamos seis revisiones sistemáticas que en conjunto incluyeron siete estudios primarios, de los cuales, todos corresponden a ensayos aleatorizados. Concluimos que el uso de suero autólogo podría no presentar efectos adversos asociados a su uso, pero la certeza de la evidencia es baja. Por otro lado, no es posible establecer con claridad si el uso de suero autólogo tiene un efecto sobre la mejora de la calidad de vida, severidad del ojo seco, dolor o grado de epiteliopatía corneal debido a que la certeza de la evidencia existente ha sido evaluada como muy baja.

Comparative study on the efficacy of non-steroidal, steroid and non-use of anti-inflammatory in the treatment of acute epidemic conjunctivitis.

PURPOSE: To evaluate the effects of prednisolone against sodium diclofenac both with ciprofloxacin compared to artificial tears on the symptoms and signs of acute viral conjunctivitis. METHODS: Study included 37 patients diagnosed with acute conjunctivitis and distributed by three groups: A (1% prednisolone acetate + ciprofloxacin (0.3%); B (Sodium diclofenac (0.1%) + ciprofloxacin (0.3%) and C (artificial tears + ciprofloxacin (0.3%). Patients received medication 6/6 hours daily. Signs and symptoms (e.g. lacrimation, burning, photophobia, etc.) were scored at baseline and on the first, third, fifth and seventh days and in the end of treatment using a standardized questionnaire and slit lamp anterior segment examination. RESULTS: All three groups demonstrated an improvement in the signs and symptoms of conjunctivitis in their follow-up visits. There was no significant difference in symptom and sign scores between Group A and B and B and C in the study visits ( p >0.05). However, the comparison between groups A and C showed a clinical trend (p=0.05) on third evaluation suggesting better clinical action using the corticosteroids. CONCLUSION: The prednisolone acetate was not superior to the use of sodium diclofenac or artificial tears in relieving the signs and symptoms of viral conjunctivitis.

Comparative study on the efficacy of non-steroidal, steroid and non-use of anti-inflammatory in the treatment of acute epidemic conjunctivitis

Abstract Purpose To evaluate the effects of prednisolone against sodium diclofenac both with ciprofloxacin compared to artificial tears on the symptoms and signs of acute viral conjunctivitis. Methods Study included 37 patients diagnosed with acute conjunctivitis and distributed by three groups: A (1% prednisolone acetate + ciprofloxacin (0.3%); B (Sodium diclofenac (0.1%) + ciprofloxacin (0.3%) and C (artificial tears + ciprofloxacin (0.3%). Patients received medication 6/6 hours daily. Signs and symptoms (e.g. lacrimation, burning, photophobia, etc.) were scored at baseline and on the first, third, fifth and seventh days and in the end of treatment using a standardized questionnaire and slit lamp anterior segment examination. Results All three groups demonstrated an improvement in the signs and symptoms of conjunctivitis in their follow-up visits. There was no significant difference in symptom and sign scores between Group A and B and B and C in the study visits ( p >0.05). However, the comparison between groups A and C showed a clinical trend (p=0.05) on third evaluation suggesting better clinical action using the corticosteroids. Conclusion The prednisolone acetate was not superior to the use of sodium diclofenac or artificial tears in relieving the signs and symptoms of viral conjunctivitis.

Variação do volume de gotas de colírios lubrificantes disponíveis no mercado brasileiro / Variation in the volume of lubricating eyedrops available in the brazilian market

RESUMO Objetivo: Avaliar a variação intra e interexaminadores do volume de gotas dispensados de frascos de colírios lubrificantes disponíveis no mercado. Métodos: Foram estudados cinco frascos de colírios lubrificantes e dezenove voluntários participaram deste estudo. A massa média de gotas de 20µl dos colírios foi obtida utilizando micropipeta e balança de precisão e como padrão para comparação com a massa das gotas obtidas pelos voluntários. Cinco gotas de cada frasco foram pesadas individualmente com o tubo de colírio perpendicular à balança, usando o primeiro e segundo dedos da mão direita, de forma que a pressão fosse aplicada somente no meio do frasco. Os experimentos foram realizados em uma sala climatizada a temperatura ambiente (21±1°C). Resultados: Todos os frascos de colírios apresentaram variação estatisticamente significante das massas das gotas obtidas pelos examinadores quando comparadas com a massa média padrão de 0,0182±0,0014g, com exceção da comparação entre os dados do colírio A com o colírio D, que não apresentou variação estatisticamente significante. Conclusão: O presente estudo demonstra a ausência de uniformidade das gotas dispensadas pelos frascos de colírios disponíveis no mercado e a sua inadequação à real necessidade, uma vez que as gotas dispensadas são maiores do que o indicado. Esse fato torna-se um problema quando se trata de período de tratamento prolongado, especialmente com colírios dispendiosos como os indicados para a terapêutica do glaucoma. Nesse sentido, a padronização das gotas de colírios se faz necessária.

ABSTRACT Objective: To evaluate the intra and inter variations of eye drops volume dispensed from bottles available on the market. Methods: Five bottles of lubricant eye drops were studied and nineteen volunteers participated in this study. The average mass from 20µl of eye drops was obtained using accuracy micropipette and balance, and used as standard for comparison with the mass of the drops obtained by the volunteers. Five drops of each vial were individually weighed with the tube perpendicular to the balance, using the first and second fingers of the right hand, so that the pressure was applied only in the middle of the flask. The experiments were performed in a room temperature (21±1°C). Results: All eye drops bottles showed a statistically significant variation on masses of the drops obtained by examiners when compared with the standard average weight of 0.0182±0,0014g, except when compared A with D eye drops, with no statistically significant variation. Conclusion: This study demonstrates the lack of uniformity of drops dispensed by eye drops bottles available in the market and its inadequacy to the real need, since the dispensed drops are larger than indicated.This fact becomes a problem when it comes to long treatment period, especially with expensive drops as indicated for glaucoma therapy. In this sense, the standardization of drops of eye drops is necessary.

Volume da gota dos colírios lubrificantes: estudo farmacoeconômico / Drop volume of artificial tear solutions: pharmacoeconomic study

RESUMO Objetivo: Determinar o volume médio das gotas produzidas pelos colírios lubrificantes em diferentes ângulos de inclinação e determinar o custo médio do tratamento. Métodos: Determinação do volume da gota de 3 frascos originais dos colírios lubrificantes Artelac®, Hylo Comod®, Lacrima® Plus, Systane® UL, Lacrifilm®, Hyabak®, Lacribell®, Ecofilm®, Mirugell®, Plenigell®, Fresh Tears®, Optive® e Endura® à inclinação de 90º e 45º. Determinou-se o número médio de gotas em cada frasco e foi feita avaliação farmacoeconômica dos colírios. Resultados: O volume das gotas variou de 32,2 a 64,0 µL a 45o e de 29,1 a 65,1 µL a 90o. A diferença entre as gotas em cada inclinação foi de 2 a 24% e o custo anual dos colírios de acordo com a inclinação variou de R$2,73 a R$130,73. A Duração Máxima de Tratamento (DMT) foi de 29,3 a 51,4 dias na inclinação de 45o, e de 28,8 a 48,4 dias a 90º, sendo que a diferença na DMT foi de 0,5 até 8 dias a mais ou a menos, de acordo com a marca. Conclusão: Nenhum dos colírios estudados apresentou gotas ideais para o olho humano, levando a um desperdício do produto e maior custo para o fabricante e para o consumidor. Percebemos que existe uma variação significativa no volume da gota de acordo com a inclinação do frasco, e que uma variação maior do que 10% traria impactos financeiros para o paciente.

ABSTRACT Objective: To determine the mean drop volume produced by artificial tear solutions in different inclination angles and to determine the mean cost of the treatment. Methods: The drop volume of 3 original bottles of the artificial tear solutions Artelac®, Hylo Comod®, Lacrima® Plus, Systane® UL, Lacrifilm®, Hyabak®, Lacribell®, Ecofilm®, Mirugell®, Plenigell®, Fresh Tears®, Optive® and Endura® were determined at the inclination of 90º and 45º. The mean number of drops in each bottle was determined and a pharmacoeconomic evaluation of the drops was made. Results: The drop volume ranged from 32.2 to 64.0 µL at 45º and from 29.1 to 65.1 µL at 90º. The difference between drops in each inclination varied from 2 to 24%. The annual cost was from R$2,73 to R$130,73 according to the inclination of the bottle. The Maximum Duration of Treatment (MDT) was from 29.3 to 51.4 days at 45o and from 28.8 to 48.4 days at 90º, being the difference in MDT from 0.5 to 8 more or less days depending on each brand. Conclusion: None of the collyria studied presented ideal drops for human eyes, leading to a waste of the product and higher cost for the manufacturer and the consumer. We noted that there is a significant variation in the drop volume according to the inclination of the bottle, and that a variation of over 10% would bring financial impact for the patient.

Artificial tears alone versus 0.45% ketorolac tromethamine with artificial tears for the treatment of acute viral conjunctivitis.

PURPOSE: To evaluate the effects of preservative-free 0.45% ketorolac tromethamine and artificial tears (carboxymethylcellulose) compared with those of preservative-free artificial tears alone on the symptoms and signs of acute viral conjunctivitis. METHODS: This was a randomized, double-masked clinical trial that included 50 patients who were diagnosed with acute viral conjunctivitis and distributed into two groups (Group 0: artificial tears and Group 1: 0.45% ketorolac tromethamine + carboxymethylcellulose). The patients were instructed to use the medication 4 times daily. Signs (conjunctival hyperemia, chemosis, follicles, and secretion) and symptoms (general ocular discomfort, itching, foreign body sensation, tearing, redness, and swelling of the eyelids) were scored at baseline and on the third and seventh days of treatment using a standardized questionnaire and slitlamp anterior segment examination. RESULTS: Both groups showed an improvement in the signs and symptoms of conjunctivitis in their follow-up visits. There was no significant difference in symptom and sign scores between Group 0 and Group 1 in the study visits (p>0.05). The frequency of side effects during treatment was similar between groups (p>0.05). CONCLUSIONS: Our findings indicate that 0.45% ketorolac tromethamine was not superior to the use of artificial tears in relieving the signs and symptoms of viral conjunctivitis.

Artificial tears alone versus 0.45% ketorolac tromethamine with artificial tears for the treatment of acute viral conjunctivitis / Lágrima artificial versus cetorolaco de trometamina 0,45% associado à lagrima artificial no tratamento da conjuntivite viral aguda

Purpose: To evaluate the effects of preservativefree 0.45% ketorolac tromethamine and artificial tears (carboxymethylcellulose) compared with those of preservativefree artificial tears alone on the symptoms and signs of acute viral conjunctivitis. Methods: This was a randomized, doublemasked clinical trial that included 50 patients who were diagnosed with acute viral conjunctivitis and distributed into two groups (Group 0: artificial tears and Group 1: 0.45% ketorolac tromethamine + carboxymethylcellulose). The patients were instructed to use the medication 4 times daily. Signs (conjunctival hyperemia, chemosis, follicles, and secretion) and symptoms (general ocular discomfort, itching, foreign body sensation, tearing, redness, and swelling of the eyelids) were scored at baseline and on the third and seventh days of treatment using a standardized questionnaire and slitlamp anterior segment examination. Results: Both groups showed an improvement in the signs and symptoms of conjunctivitis in their follow-up visits. There was no significant difference in symptom and sign scores between Group 0 and Group 1 in the study visits (p>0.05). The frequency of side effects during treatment was similar between groups (p>0.05). Conclusions: Our findings indicate that 0.45% ketorolac tromethamine was not superior to the use of artificial tears in relieving the signs and symptoms of viral conjunctivitis. .

Objetivo: Avaliar o efeito do colírio de cetorolaco de trometamina 0,45% associado à carboximetilcelulose sem conservante em comparação ao uso isolado de lágrimas artificiais sem conservantes nos sinais e sintomas da conjuntivite viral aguda. Métodos: Ensaio clínico duplo-mascarado randomizado incluindo 50 pacientes com diagnóstico de conjuntivite viral aguda, distribuídos em dois grupos (Grupo 0: lágrimas artificiais e Grupo 1: cetorolaco 0,45% + carboximetilcelulose). Os pacientes foram orientados a utilizar a medicação quatro vezes ao dia. Sinais (hiperemia conjuntival, quemose, folículos e secreção) e sintomas (desconforto ocular geral, prurido, sensação de corpo estranho, lacrimejamento, vermelhidão e inchaço de pálpebras) foram avaliados na consulta inicial, no terceiro e no sétimo dia de tratamento utilizando um questionário padronizado e biomicroscopia de segmento anterior. Resultados: Ambos os grupos apresentaram melhora dos sinais e sintomas de conjuntivite nas visitas de reavaliação. Não foi observado diferença estatística na mudança dos escores dos sinais e sintomas entre o Grupo 0 e o Grupo 1 durante as visitas do estudo (p>0.05). A frequência de efeitos colaterais durante o tratamento foi similar entre os dois grupos (p>0.05). Conclusão: O uso do cetorolaco de trometamina 0,45% não se mostrou superior ao uso isolado de lágrimas artificiais no alívio dos sinais e sintomas da conjuntivite viral. .

Effects of benzalkonium chloride on the blood-aqueous and blood-retinal barriers of pseudophakic eyes.

PURPOSE: To evaluate the effects of benzalkonium chloride (BAK) on the blood-aqueous (BAB) and blood-retinal barriers (BRB) of pseudophakic eyes. METHODS: Prospective, randomized, investigator-masked, comparative study. Patients were randomly assigned to preservative-free artificial tears or BAK-preserved artificial tears. One drop of artificial tears was instilled 4 times a day in the study eye, starting the day after randomization for 30 days. Anterior chamber flare was assessed by a laser flare meter (LFM) and macular thickness measurements were obtained with optical coherence tomography, before, 15, and 30 days after randomization. RESULTS: A total of 44 healthy eyes of 44 pseudophakic volunteers were recruited. There were no significant differences regarding demographics (age, gender, and race distributions) and clinical characteristics (eye, mean intraocular pressure, and mean best-corrected visual acuity) between the 2 groups (P>0.05). No significant differences in baseline mean LFM values were observed (P=0.262). However, we detected a statistically significant increase in mean LFM measurements in the BAK-preserved group (11.4 ± 5.1 ph/ms) (P=0.017) after 15 days. After 30 days, the BAK-preserved group maintained significantly higher flare values (11.9 ± 5.9 ph/ms) compared with baseline (P=0.043). On the other hand, the preservative-free group showed mean flare values of 8.4 ± 2.5 ph/ms, not significantly different from those obtained at baseline (P=1.00). We observed no statistically significant change in macular thickness measurements at days 15 and 30 in either group (P>0.05). Cystoid macular edema was not detected in this series. CONCLUSIONS: Our results suggest that a short-term exposure to BAK can cause disruption of the BAB, without altering the BRB in pseudophakic eyes.

Efectividad y seguridad de carboximetil celulosa tópica para el tratamiento sintomático del ojo seco / Effectiveness and safety of topical carboxymethyl cellulose for the symptomatic treatment of dry eye

Antecedentes: Descripción de la condición de salud de interés: El síndrome de ojo seco se define como una enfermedad multifactorial de las lágrimas y de la superficie ocular que resulta en síntomas de disconfort, alteraciones visuales e inestabilidad de la capa acuosa del ojo con un daño potencial a la superficie ocular. La comparación de datos estratificados por edad acerca de la prevalencia de la enfermedad en estudios epidemiológicos de gran tamaño, dan cuenta de una prevalencia del 5 al 35%, una afectación mayor de los hispanos y de los asiáticos cuando son comparados contra los caucásicos. Descripción de la tecnolo\r\ngía: El tratamiento más común para la condiciónde Ojo Seco, es el uso de lágrimas artificiales en forma de colírios o gotas, se administran con el fin de complementar la producción de lágrimas naturales. Las lágrimas naturales constan de siete elementos básicos: agua, solución salina, sustancias que mejoran su permanencia en el ojo y conservantes. Contienen diferentes tipos de polímeros que actúan como ingredientes activos que buscan proteger la superficie de la mucosa ocular. Evaluación de efectividad y seguridad: Pregunta de investigación: En pacientes con síndrome de ojo seco ¿es más efectiva y segura la caroboximetilcelulosa comparado con no hacer nada? La pregunta de investigación fue validada teniendo en cuenta las siguientes fuentes de información: registro sanitario INVIMA, Acuerdo 029 de 2011, guías de práctica clínica, reportes de evaluación de tecnologías, revisiones sistemáticas y narrativas de la literatura, estudios de prevalencia/incidencia y carga de enfermedad, consulta con expertos temáticos, y otros actores clave. Población: Pacientes con síndrome de ojo seco. Tecnología de interés: Carboximetilcelulosa. Metodología: Búsqueda de literatura, Búsqueda en bases de datos electrónicas. Conclusiones: Con el protocolo de búsqueda establecido no se halló evidencia que permita establecer la efectividad y la seguridad de la carboximetilcelulosa para el tratamiento de pacientes con síndrome de ojo seco.

Percepção da administração tópica ocular de drogas: aplicador facial x gotas / Topical drug administration perception with and without eye drop applicator

OBJETIVOS: Avaliar por meio de questionário, qual o grau de dificuldade para aplicação tópica de medicações oculares, com ou sem o auxílio do apoio facial. Observar qual método foi tecnicamente melhor utilizado para aplicação de drogas tópicas oculares. MÉTODOS: O estudo foi um ensaio clínico controlado e randomizado, realizado em 50 pacientes no decorrer de 2009 e 2010 na Unidade de Saúde da Família - Lapa. Foi utilizado um frasco de colírio Oftane® e o mesmo foi acoplado ao dispositivo de apoio facial. Cada participante aplicou em cada um dos olhos, a solução com ou sem o uso do dispositivo, sendo que a seleção foi feita através de um processo randomizado. Foi perguntado ao paciente questões pré-formuladas sobre a praticidade de ambos os métodos. RESULTADOS: Considerando o grau de dificuldade de administração tópica ocular: 12 por cento acharam difícil ou muito difícil a aplicação com o objeto de apoio facial e 22 por cento sem o apoio (p=0,0024). As dificuldades descritas pelos pacientes foram relatadas por 22 por cento dos pacientes para aplicação com o dispositivo de apoio facial e por 46 por cento para aplicação sem o mesmo. Já 34 por cento dos pacientes necessitaram de mais de uma instilação para aplicação do colírio sem o apoio, enquanto que 54 por cento dos pacientes precisaram de mais de uma aplicação para que a gota atingisse o olho com o auxílio do apoio facial (p= 0,04). Em 56 por cento dos pacientes houve toque da ponta do colírio com os tecidos oculares, quando o objeto de apoio facial não foi usado, porém quando ele foi utilizado, apenas 2 por cento dos pacientes observados tocaram os tecidos oculares (p=0,0001). CONCLUSÃO: É mais fácil a instilação de colírios com o auxílio do dispositivo de apoio facial. Este também dificulta o contato da ponta do frasco com os tecidos oculares, prevenindo a contaminação do frasco.

OBJECTIVE: Evaluate how difficult it is to apply ocular topical medications with and without an eye dropper facial applicator based on patient observation and answers to a questionnaire. METHODS: The study was a controlled and randomized clinical trial performed in 50 patients during the years of 2009 and 2010 in PSF - Lapa. Eye drops were applied with and without aid of an eye dropper facial applicator. Each individual tested applied randomly on one of their eyes an eye drop with or without the applicator. The patients had to answer questions about the practice concerning both forms of topical eye drug application. RESULTS: 12 percent informed that it was difficult or very difficult to instill eye drops and 22 percent to instill eye drops helped by an eye dropper facial applicator (0,0024). Problems described by patients were considered by 22 percent for eye drops with the applicator and by 46 percent for topical eye drop instillation without it. 34 percent of the patients needed more than one eye drop application to have eye drop contact , while 54 percent of the patients needed more than one application with the eye drop facial applicator in order to get drug eye contact (p= 0,04). In 56 percent of patients there were an eyedropper tip contact with ocular tissues, however there was only 2 percent of contact when the eye drop was instilled aided by the applicator (p=0,0001). CONCLUSION: It is easier to instill an eye drop with the help of an eye dropper applicator than without it. This dispositive also reduces the eyedropper tip contact with the ocular tissues.