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1.
Ocul Immunol Inflamm ; 31(8): 1653-1661, 2023 Oct.
Article in English | MEDLINE | ID: mdl-35914297

ABSTRACT

PURPOSE: To evaluate the efficacy and safety of lotilaner ophthalmic solution, 0.25% eyedrops compared to vehicle for the treatment of Demodex blepharitis. METHODS: In this randomized, controlled, double-masked clinical trial, 54 participants were randomly assigned in a 1:1 ratio to receive either lotilaner ophthalmic solution, 0.25% (study group) or the vehicle (control group) bilaterally, twice daily for 42 days. Outcome measures were collarette cure (collarette grade 0, upper eyelid), mite eradication (mite density of 0 mites/lash), and composite cure (grade 0 for collarettes and erythema). RESULTS: The proportion of participants achieving collarette cure (80.0% vs 15.8%; p < .001), mite eradication (73.3% vs 21.1%, p = .003) and composite cure (73.3% vs 10.5%, p < .001) at Day 42 was statistically significantly higher in the study group than the control group. CONCLUSION: Twice-daily 42-day treatment with novel lotilaner ophthalmic solution, 0.25% is safe and effective for the treatment of Demodex blepharitis compared to the vehicle control. (Registry number: ACTRN12620000320954, dated 09/03/2020).


Subject(s)
Blepharitis , Eye Infections, Parasitic , Mite Infestations , Mites , Animals , Humans , Mite Infestations/drug therapy , Blepharitis/diagnosis , Blepharitis/drug therapy , Ophthalmic Solutions , Prospective Studies , Eye Infections, Parasitic/diagnosis , Eye Infections, Parasitic/drug therapy
2.
Cont Lens Anterior Eye ; 45(4): 101492, 2022 08.
Article in English | MEDLINE | ID: mdl-34332895

ABSTRACT

PURPOSE: To evaluate the safety and efficacy of lotilaner ophthalmic solution, 0.25% for the treatment of blepharitis due to Demodex infestation compared to vehicle control. METHODS: In this phase II, randomized, controlled, double-masked clinical trial, 60 eligible participants with Demodex blepharitis were randomly assigned in a 1:1 ratio to receive either topical lotilaner ophthalmic solution, 0.25% (Tarsus Pharmaceuticals, Inc., Irvine, CA) (study group) or the vehicle without lotilaner (control group) bilaterally twice a day for 28 days. Participants were followed at Days 7, 14, 28, 60 and 90. The efficacy parameters were change in collarette grade and Demodex density at Day 28. Safety parameters were adverse events, changes in corrected distance visual acuity (CDVA), intraocular pressure (IOP) and slit-lamp biomicroscopy. RESULTS: The study group showed a statistically significant decrease in collarette grade compared to the control group beginning at Day 14 (p = 0.003) in the upper eyelid and at Day 28 (p = 0.003) in the lower eyelid. Decreases in both lids were maintained through Day 90 (p < 0.001). At Day 28, mite eradication was achieved in 66.7% and 25.9% of eyes in the study and control group (p = 0.005); at Day 90, these proportions were 68.2% and 18.5% (p = 0.001), respectively. No serious adverse events or clinically significant changes in CDVA and IOP were observed. CONCLUSION: For Demodex blepharitis, treatment with lotilaner ophthalmic solution, 0.25% for 4 weeks is safe and effective. The improvement in collarette grade and mite density observed during the treatment period persisted for at least two months following treatment cessation.


Subject(s)
Blepharitis , Eyelashes , Mite Infestations , Mites , Animals , Blepharitis/diagnosis , Blepharitis/drug therapy , Blepharitis/etiology , Humans , Mite Infestations/complications , Mite Infestations/drug therapy , Ophthalmic Solutions , Oxazoles , Thiophenes
3.
J Ophthalmol ; 2021: 3862684, 2021.
Article in English | MEDLINE | ID: mdl-34603770

ABSTRACT

PURPOSE: Evaluate safety and efficacy of topical lotilaner ophthalmic solution, 0.25% for the treatment of Demodex blepharitis. Patients and Methods. 15 patients with Demodex blepharitis, defined as >10 collarettes on the upper lid, lid margin erythema, and Demodex density of ≥1.5 mites/lash on microscopy, were treated bid for 28 days with lotilaner ophthalmic solution, 0.25%. Contact lens wear, artificial eyelashes, and lid structural abnormalities were among the exclusion criteria. No other antibacterial, antiparasitic, or anti-inflammatory treatment or lid hygiene products were permitted. Patients were assessed on Days 7, 14, 28, 60, and 90. Outcome measures were changes in collarette grade and mite density on Day 28. Adverse events and changes in intraocular pressure (IOP), corrected distance visual acuity (CDVA), and slit-lamp biomicroscopy were assessed. RESULTS: Mean collarette grade (upper lids) improved from 3.07 ± 0.21 to 0.79 ± 0.19 on Day 28; the change was statistically significant for both upper and lower lids from Day 14 on. Mean mite density per lash decreased from 2.28 ± 0.16 at baseline to 0.14 ± 0.05 at Day 28 (p < 0.0001). Mite eradication (0 mites) was documented in 57.1% of eyes. The effects were durable through Day 90. There were no adverse events and little to no change in CDVA or IOP. The drop was well tolerated, with no discontinuations due to ocular irritation. CONCLUSION: Topical lotilaner ophthalmic solution, 0.25% for 4 weeks, showed promising efficacy for the treatment of Demodex blepharitis. This novel treatment appears to be safe and well tolerated. Randomized controlled studies are needed to confirm the results.

4.
J Ocul Pharmacol Ther ; 37(8): 479-484, 2021 10.
Article in English | MEDLINE | ID: mdl-34415795

ABSTRACT

Purpose: To evaluate the efficacy of topical lotilaner ophthalmic solution, 0.25%, in patients with Demodex blepharitis. Methods: Eighteen adults with Demodex blepharitis, defined as >10 collarettes on the upper lid and/or mite density of ≥1.5 mites per lash (upper and lower), were treated bid for 42 days with the topical lotilaner ophthalmic solution, 0.25%. Contact lens wear, artificial eyelashes, and lid structural abnormalities were among the exclusion criteria. No other antibacterial, antiparasitic, or anti-inflammatory treatment or lid hygiene products were permitted. One eye of each patient was selected for analysis and assessed on day 7, 14, 28, and 42. Collarettes were graded at each visit, and mite density was evaluated by microscopy at each visit except day 7. Outcome measures were collarette elimination (≤2 lashes with collarettes) and mite eradication (0 mites). Drop tolerability, adverse events, visual acuity, and slit-lamp biomicroscopy were assessed. Results: Collarette elimination was achieved in 13/18 participants (72.2%) by day 42. Mean collarette grade (upper lid) declined from 3.56 ± 0.17 to 0.28 ± 0.11. Mite eradication was achieved in 14/18 participants (77.8%) by day 42. Mean mite density decreased from 2.63 ± 0.39 to 0.12 ± 0.08 mites/lash. Participants reported good tolerability. Adverse events were mild and transient and did not result in treatment discontinuation. Conclusion: Six weeks of at-home topical therapy with the lotilaner ophthalmic solution, 0.25%, was effective in eliminating the most common objective signs of Demodex blepharitis, with a collarette elimination rate of 72% and mite eradication in 78% of eyes by day 42. ISRCTN registration #: 24398865.


Subject(s)
Antiparasitic Agents/therapeutic use , Blepharitis/prevention & control , Disease Eradication/methods , Eye Infections, Parasitic/prevention & control , Eyelashes/parasitology , Mite Infestations/prevention & control , Oxazoles/therapeutic use , Thiophenes/therapeutic use , Administration, Ophthalmic , Aged , Aged, 80 and over , Animals , Blepharitis/diagnosis , Blepharitis/parasitology , Double-Blind Method , Eye Infections, Parasitic/diagnosis , Eye Infections, Parasitic/parasitology , Female , Humans , Male , Middle Aged , Mite Infestations/diagnosis , Mite Infestations/pathology , Mites/drug effects , Ophthalmic Solutions , Treatment Outcome
5.
Liberabit ; 17(1): 7-17, ene.-jun. 2011. tab
Article in Spanish | LIPECS | ID: biblio-1109143

ABSTRACT

Este estudio empírico de corte transversal pone a prueba el supuesto de que las percepciones de bienestar social, anomia, interés político e impotencia política condicionan las actitudes hacia la democracia. Se tomó el modelo de cinco dimensiones de Keyes (1998) para medir el bienestar social y se midió el constructo anomia desde la perspectiva psicosocial de Srole (1956). La muestra conformada por 568 sujetos mayores de edad de diferentes estados de México contestó una batería que contenía cuatro cuestionarios: La Escala de Actitudes hacia la Democracia de Morales, Las Escalas de Bienestar Social de Keyes, La Escala de Anomia de Srole, La adaptación al español de la Escala de Impotencia Política y un ítem de valor único sobre Interés por la Política tomado de la Encuesta Social Europea 2006. Las correlaciones de bienestar social e interés por la política son positivas para la aceptación de la democracia. Los resultados muestran que a mayor percepción de anomia e impotencia política mayor rechazo de la democracia.


This empirical and transversal paper tests the hypothesis that perceived social well-being, anomie, political interest, and political powerlessness condition attitudes towards democracy. We adopted the Keyes' five-dimension model to measure social well-being and the Srole's (1956) psychosocial perspective for anomie. A sample of 568 legally adult subjects of different states of Mexico filled out a battery containing four questionnaires: Morales' Attitudes Towards Democracy Scale, Keyes' Social Well-being Scales, Srole Anomie Scale, an adaptation into Spanish language of The Powerlessness Scale, and one item of unique value for Political Interest taken from the 2006 European Social Survey. Correlations between social wellbeing, political interest and acceptance of democracy were positives. Results show that higher perception of anomie and political powerlessness indicates more rejection of democracy.


Subject(s)
Male , Female , Humans , Adolescent , Young Adult , Adult , Middle Aged , Aged , Aged, 80 and over , Anomie , Democracy , Perception , Politics , Psychology, Social , Social Welfare , Cross-Sectional Studies
6.
Pensam. psicol ; 9(16): 11-26, ene.-jun. 2011. ilus, tab
Article in Spanish | LILACS | ID: lil-708931

ABSTRACT

Objetivo. El presente estudio empírico intercultural parte de los presupuestos de la psicología del bienestar subjetivo aplicados al ámbito laboral. Con un propósito general comparativo, se estudia, en primer lugar, la relación e influencia de factores de afectividad, personalidad y sociodemográficos en el bienestar laboral de profesores no universitarios de España y México, y posteriormente, se identifica el conjunto de factores que predicen mejor la satisfacción laboral intrínseca. Método. Se adoptó el modelo de tres ejes de Peter Warr (2003), para medir el bienestar laboral considerando la activación mental. Una muestra de 133 profesores españoles de la provincia de Guipúzcoa y otra de 101 profesores mexicanos del estado de Colima contestaron a una batería con cuatro instrumentos validados. Resultados. Los resultados obtenidos indican la existencia de diferencias personales significativas en la percepción del bienestar laboral entre las dos culturas. La afectividad (positiva y negativa) predice la satisfacción laboral (alta y baja) para ambas muestras. Conclusión. Para los profesores españoles los factores afabilidad y apertura mental predicen un nivel de satisfacción alta, y para los profesores mexicanos únicamente el factor de personalidad afabilidad resultó ser predictivo.


Objective. This intercultural empirical study is based on the assumptions of the psychology of subjective welfare applied to a working environment. With a comparative general purpose, studies were conducted in the first instance on the relationship and influence of factors of affectiveness, personality, and of a demographic nature on the wellbeing of non-university professors from Spain and México in their places of work. Subsequently, a set of factors which offered a better prediction of genuine work-related satisfaction was determined. Method. Peter Warr's three axes model (2003) was adopted to measure work-related wellbeing, taking into consideration mental activation. A sample of 133 Spanish professors from the the Guipúzcoa province and a further 101 Mexican professors from the state of Colima answered a battery of questions with four validated instruments. Results. The results obtained showed that there are significant personal differences in the perception of work-related wellbeing between the two cultures. Affectiveness (positive and negative) predicts work-related satisfaction (high and low) for both samples. Conclusion. For the Spanish professors, pleasantness and an open mind predicted a high level of satisfaction, but for the Mexicans the only predictive factor was pleasantness.


Escopo. O presente estudo empirico intercultural parte dos pressupostos da psicología do bem-estar subjetivo aplicados ao âmbito laboral. Com um proposto geral comparativo, estuda-se no primeiro lugar a relação e influencia de fatores de afetividade, personalidade e sócio-demográficos no bem-estar laboral de professores não universitários da Espanha e o México, e posteriormente, identifica-se o conjunto de fatores que predisse melhor a satisfação laboral intrínseca. Metodologia. Adotou-se o modelo de três eixos do Peter Warr (2003) para medir o bem-estar laboral considerando a ativação mental. Uma amostra de 133 professores espanhóis da provincia de Guipúzcoa e outra de 101 professores mexicanos do estado de Colima responderam para uma batería com quatro instrumentos avaliados. Resultados. Para os professores espanhóis os fatores de afabilidade e apertura mental predizem um nivel de satisfação alta, e para os professores mexicanos só o fator de personalidade afabilidade resultou ser preditivo.


Subject(s)
Humans , Personality , Psychology, Industrial , Cultural Diversity , Affect , Job Satisfaction
7.
Photochem Photobiol ; 86(2): 438-44, 2010.
Article in English | MEDLINE | ID: mdl-19947968

ABSTRACT

A number of studies published in the scientific literature have shown the relationship between sun exposure and nonmelanoma skin cancer (NMSC) and vitamin D synthesis. However, the paucity of medical data, particularly in developing countries, hampers a global assessment of the impact of sun exposure on NMSC and vitamin D. To improve knowledge on this subject, this paper presents UV index (UVI) measurements performed in São Paulo City (SPC) in the period 2005-2008. It was found that 65% of the UVI measured 2 h around local noon during the summer show very high (8 < UVI < 10) and extreme (UVI > 11) levels according to the World Health Organization (WHO) classification. During the winter, 40% of the measurements around noontime show high or very high levels. In spite of worrisome recent statistics from SPC, showing that NMSCs make up about 28% of over a million of new cases of cancer in 2008, sun protection is not considered a real problem in these urban areas. UV measurements also show that every month of the year UV levels are high enough to ensure vitamin D production in human skin from incidental sun exposure.


Subject(s)
Environmental Exposure/statistics & numerical data , Skin Neoplasms/epidemiology , Sunlight , Vitamin D/biosynthesis , Brazil/epidemiology , Cities , Humans , Radiation Dosage , Seasons , Skin Neoplasms/etiology , Ultraviolet Rays
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