The Effect of Sodium Hyaluronate Eye Drops 2, 4 or 6 Times a Day on Signs and Symptoms of Dry Eye Disease.

Purpose: A randomized clinical trial was run to evaluate the effectiveness of a preservative-free 0.4% sodium hyaluronate eye drop (LOF) in different dosage schemes to alleviate signs and symptoms of dry eye disease (DED). Methods: A total of 116 subjects with mild-to-moderate DED were included, and 111 completed the study (from which 67.6% were female and 65.3% were users of oral contraceptives). Patients were randomly assigned to instill a drop of LOF either 2 (BID), 4 (QID) or 6 (6TD) times a day (at least 3 hours apart) for 30 days. The clinical parameters and symptom endpoints were Ocular Surface Disease Index (OSDI), tear break-up time (TBUT), ocular surface staining, and conjunctival hyperemia. Other parameters evaluated were chemosis, best corrected visual acuity, and the incidence of adverse events (AE). Results: There was a significant reduction in OSDI scores by day 30 in all groups. The recovery of the OSDI score back to normal values was observed in 51.4% of patients treated (50%, 48.6%, and 55.6% in BID, QID, and 6TD, respectively, p = 0.822). Similar improvement was observed for TBUT, 50.5% of patients increased this variable to >10 seconds (39.5%, 51.4%, and 61.1%, p = 0.175), and for ocular surface staining, ≥72% showed Grade 0. There were no significant differences among posology groups regarding ocular surface staining, conjunctival hyperemia, or any safety parameters. No overall improvement in OSDI and TBUT to normal values was noted for 31 patients (21 were female and 71.4% users of contraceptive drugs). Conclusion: The ophthalmic use of preservative free LOF, 2, 4 or 6 times a day, may alleviate clinical parameters and symptoms in 50% of patients with mild-to-moderate DED after a one-month treatment. This improvement seemed to be less ubiquitous in patients within reproductive age and using oral contraceptives. Trial Registration: This trial is registered at clinicaltrials.gov (NCT0704531).

Ocular Surface Evaluation after Switch from Latanoprost 0.005% to Latanoprostene Bunod 0.024.

Aim and background: To evaluate the ocular surface of patients treated with latanoprost (LT) 0.005% who switched to latanoprostene bunod (LBN) 0.024%. Materials and methods: A prospective and nonrandomized clinical study of a case series was performed, including patients with chronic open-angle glaucoma who were on previous LT-only treatment and, after a washout period, switched to LBN, with a 3-month follow-up. The main parameter to be evaluated was the ocular surface disease index (OSDI) test. In addition, best-corrected visual acuity (BCVA), intraocular pressure (IOP), biomicroscopic aspect of the ocular surface, measuring tear breakup time, fluorescein staining (grading performed on Oxford scale) and Schirmer I test were evaluated. Results: A total of 36 patients (72 eyes) were included, 21 women (58.3%) and 15 men (41.7%, with a mean age of 65.6 ± 10.9 years (37-86). The initial OSDI score was 17.8 ± 12.1 and improved to 11.1 ± 10.5 (p < 0.01). From the data evaluated at biomicroscopy, an improvement was observed in the Oxford scale from 0.6 ± 0.7 to 0.2 ± 0.8 (p: 0.01), but no statistically significant changes were observed in the break-up time (BUT) and Schirmer. BCVA remained stable, as did IOP, which was initially 13.4 ± 2.1 mm Hg and, after performing the LBN treatment change, went to 13.1 ± 1.7 mm Hg. Conclusion: After the change of treatment from LT 0.005% to LBN 0.024%, the patients had an improvement in the ocular surface, maintaining control of their IOP. The need to investigate possible beneficial mechanisms on the ocular surface in glaucoma patients treated with LBN, potentially related to nitric oxide, is raised. Clinical significance: Patients treated with LT 0.005% who switched to LBN 0.024% had an improvement in ocular surface symptoms and signs, keeping IOP under control.Latanoprostene bunod (LBN) 0.024% may have beneficial effects on the ocular surface, which should be further studied. How to cite this article: Zanutigh V, Galetto L, Valvecchia F, et al. Ocular Surface Evaluation after Switch from Latanoprost 0.005% to Latanoprostene Bunod 0.024%. J Curr Glaucoma Pract 2023;17(4):205-209.

Efficacy and safety of bromfenac 0.09% and sodium hyaluronate 0.4% combination therapy, versus placebo in patients with pterygium I-III for clinical signs on ocular inflammation.

Purpose: This study evaluated the clinical efficacy and safety of bromfenac 0.09%, sodium hyaluronate 0.4% (SH) combination therapy, versus placebo and SH in a clinical model of pterygium I-III. Methods: A total of 166 eyes (99 patients) with pterygium grade I-III were randomized to bromfenac 0.09% ophthalmic solution+SH 0.4% or placebo+SH 0.4%. This was a Phase IV, prospective, parallel, double-masked, multicenter clinical trial. One drop of bromfenac or placebo was instilled two times a day (BID) for 20 days, both groups accompanied treatments with one drop of SH three times a day (TID). The primary efficacy endpoints were the conjunctival hyperemia and the Ocular Surface Disease Index (OSDI) score. Other results measured included burning, foreign body sensation, and photophobia. The safety was assessed by the tear break-up time (TBUT), visual acuity (VA), IOP, lissamine green, fluorescein stains, and the incidence of adverse events (AEs). Results: Compared with baseline, there was a significant reduction in the conjunctival hyperemia (p=0.0001) and OSDI score in both groups (p=0.0001). There was a significant improvement in ocular symptomatology for both, placebo/SH and bromfenac/SH groups (p=0.0001), the decrement in the ocular burning was 41.1% vs 24.6%, the foreign body sensation was 31.5% vs 36.2% and, for photophobia was 23.3% vs 30.5%, respectively. A statistically significant difference was observed in TBUT for bromfenac/SH (p=0.045), at day 20. There were no significant alterations in IOP (p=0.068) or VA (p=0.632). Similar improvements were observed in the fluorescein and green lissamine staining. Finally, the incidence of AE was similar between groups. Conclusion: The treatment with bromfenac 0.09% ophthalmic solution and SH 0.4% combination therapy for 3 weeks reduced clinical signs, in patients with pterygium I-III. The results suggest that bromfenac 0.09% can improve the symptomatology, reduce the presentation of clinical signs associated with superficial ocular inflammation.

Enhancing the cross-cultural adaptation and validation process: linguistic and psychometric testing of the Brazilian-Portuguese version of a self-report measure for dry eye.

OBJECTIVES: To provide a reliable, validated, and culturally adapted instrument that may be used in monitoring dry eye in Brazilian patients and to discuss the strategies for the enhancement of the cross-cultural adaptation and validation process of a self-report measure for dry eye. METHODS: The cross-cultural adaptation process (CCAP) of the original Ocular Surface Disease Index (OSDI) into Brazilian-Portuguese was conducted using a 9-step guideline. The synthesis of translations was tested twice, for face and content validity, by different subjects (focus groups and cognitive interviews). The expert committee contributed on several steps, and back translations were based on the final rather than the prefinal version. For validation, the adapted version was applied in a prospective longitudinal study to 101 patients from the Dry Eye Clinic at the General Hospital of the University of São Paulo, Brazil. Simultaneously to the OSDI, patients answered the short form-36 health survey (SF-36) and the 25-item visual function questionnaire (VFQ-25) and underwent clinical evaluation. Internal consistency, test-retest reliability, and measure validity were assessed. RESULTS: Cronbach's alpha value of the cross-culturally adapted Brazilian-Portuguese version of the OSDI was 0.905, and the intraclass correlation coefficient was 0.801. There was a statistically significant difference between OSDI scores in patients with dry eye (41.15 ± 27.40) and without dry eye (17.88 ± 17.09). There was a negative association between OSDI and VFQ-25 total score (P < 0.01) and between the OSDI and five SF-36 domains. OSDI scores correlated positively with lissamine green and fluorescein staining scores (P < 0.001) and negatively with Schirmer test I and tear break-up time values (P < 0.001). CONCLUSION: Although most of the reviewed guidelines on CCAP involve well-defined steps (translation, synthesis/reconciliation, back translation, expert committee review, pretesting), the proposed methodological steps have not been applied in a uniform way. The translation and adaptation process requires skill, knowledge, experience, and a considerable investment of time to maximize the attainment of semantic, idiomatic, experiential, and conceptual equivalence between the source and target questionnaires. A well-established guideline resulted in a culturally adapted Brazilian-Portuguese version of the OSDI, tested and validated on a sample of Brazilian population, and proved to be a valid and reliable instrument for assessing patients with dry eye syndrome in Brazil.

Tradução e validação do índice da doença da superfície ocular para a língua portuguesa / Translation and validation of ocular surface disease index to portuguese

OBJETIVO: Desenvolver uma versão transcultural do "ocular surface disease index" (OSDI) para a população brasileira e analisar sua validade e eficácia. MÉTODOS: Baseados nas orientações de Guillemin et al. Foram convidados 4 professores de inglês, 1 médico oftalmologista, 1 médica reumatologista, 2 residentes de oftalmologia e 1 nativo-americano que não fala o português. O procedimento seguiu as etapas: tradução para o português por dois professores de inglês, avaliação das duas traduções para uma versão única, aplicação do questionário a 27 pessoas do ambulatório de oftalmologia do Hospital Universitário Evangélico de Curitiba, questionando as dúvidas e realizando as alterações para melhor compreensão dos pacientes. Após isso foi feita uma retradução para o inglês por dois professores de inglês que moraram nos EUA e transformação para uma versão única, e leitura de um cidadão nativo dos EUA que não fala português para avaliar a compreensão do questionário. O questionário validado foi aplicado a 22 pessoas do ambulatório de oftalmologia do Hospital Universitário Evangélico de Curitiba para avaliar a eficácia inter e intraentrevistador. RESULTADOS: O estudo da concordância intraobservador mostrou que as questões 1, 2, 3, 4, 7 e 11 têm concordância substancial, a questão 8 tem concordância quase perfeita e as questões 5, 6, 9, 10 e 12 têm concordância moderada. Estudando-se a concordância interobservador nota-se que existem duas questões com concordância quase perfeita (questões 2 e 7), sete questões com concordância substancial (questões 1, 2, 4, 5, 6, 8 e 9) e três questões com concordância moderada (10, 11 e 12). CONCLUSÃO: A versão apresentada OSDI tem boa concordância intra e interobservador e pode ser usada em português para avaliação da qualidade de vida em pacientes com olho seco.

PURPOSE: To develop a cross-cultural Ocular Surface Disease Index (OSDI) for the Brazilian population and analyze its validity and effectiveness. METHODS: Based on the guidelines of Guillemin et al., four English teachers, an ophthalmologist, a rheumatologist, two ophthalmology residents and a native American who does not speak Portuguese were invited. The procedure followed the steps: translation into Portuguese by two English teachers; transformation of the two translations to a single version; application of this version of the questionnaire to 27 people in the ophthalmology clinic of the Evangelic University Hospital of Curitiba, asking questions and making changes for a better understanding by the patients; retranslation into English by two English teachers who lived in the USA.; assessment for a single version, and reading them by a native USA. citizen who does not speak Portuguese to assess the comprehension of the questionnaire. The validated questionnaire was administered to 22 people in the ophthalmology clinic of the Evangelic University Hospital of Curitiba to evaluate the effectiveness of inter-and intra-interviewer. RESULTS: The study of intra-observer for each of the questions showed that the questions 1, 2, 3, 4, 7 and 11 have substantial agreement; that the question 8 had almost perfect agreement and questions 5, 6, 9, 10 and 12 have moderate agreement. Studying the inter-observer agreement it was found that there are two questions with almost perfect agreement (2 and 7); substantial agreement with seven questions (questions 1, 2, 4, 5, 6, 8 and 9) and three questions with moderate agreement (10, 11 and 12). CONCLUSIONS: The obtained version of OSDI has good inter and intra-observer agreement and can be used in Portuguese to evaluate the quality of life of people with dry eye.