Lubricating drops for contact lens discomfort in adults.

BACKGROUND: Contact lens discomfort is a symptom-based clinical diagnosis that affects 13% to 75% of contact lens wearers. The Tear Film and Ocular Surface Society defines contact lens discomfort as "a condition characterized by episodic or persistent adverse ocular sensations related to lens wear either with or without visual disturbance, resulting from reduced compatibility between the lens and ocular environment, which can lead to decreased wearing time and discontinuation from lens wear." Signs of the condition include conjunctival hyperemia, corneal and conjunctival staining, altered blinking patterns, lid wiper epitheliopathy, and meibomian gland dysfunction. Eye care specialists often treat contact lens discomfort with lubricating drops, including saline, although there is no clear evidence showing this treatment is effective and safe. OBJECTIVES: To evaluate the efficacy and safety of lubricating drops for ocular discomfort associated with contact lens wear in adults. SEARCH METHODS: We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register), MEDLINE, Embase.com, two other databases, and two trials registries to May 2024, without date or language restrictions. SELECTION CRITERIA: We included parallel-group randomized controlled trials (RCTs) that evaluated lubricating drops, including saline, versus no treatment, or that evaluated lubricating drops versus saline, in adult contact lens wearers. We included studies regardless of publication status, language, or year of publication. DATA COLLECTION AND ANALYSIS: We applied standard Cochrane methodology. The critical outcome was contact lens discomfort. Important outcomes were corneal fluorescein staining and conjunctival redness. Adverse outcomes were incident microbial keratitis, inflammatory corneal infiltrates, and participant discontinuation. We assessed risk of bias for outcomes reported in the summary of findings table using the Cochrane risk of bias tool RoB 2, and we rated the certainty of the evidence using GRADE. MAIN RESULTS: We included seven RCTs conducted in the USA, Canada, Italy, and France. They randomized a total of 463 participants to lubricating drops, saline, or no treatment. Four trials evaluated lubricating drops and saline versus no treatment, but one of them provided no usable outcome data. Three trials evaluated lubricating drops versus saline. Study characteristics All trial participants were adults, and the mean age ranged from 25.7 years to 36.7 years. The proportion of women varied from 15% to 82%. The trials lasted between one and four weeks. Of the five trials that reported contact lens discomfort, we judged three at high risk of bias, and considered the other two had some risk of bias concerns. Lubricating drops (including saline) versus no treatment Lubricating drops compared with no treatment may reduce contact lens discomfort, measured on a 37-point scale (lower is better), but the evidence is very uncertain (mean difference [MD] -5.9 points, 95% confidence interval [CI] -3.74 to -8.05; 2 RCTs; 119 participants). One trial found no difference between lubricating drops and no treatment in "end-of-day" comfort. The trial that compared saline with no treatment provided no results for the control group. Two studies measured corneal fluorescein staining on a scale of 0 to 20 (lower is better). We found low-certainty evidence of little to no difference between lubricating drops and no treatment in changes in the extent (MD -0.15 points, 95% CI -0.86 to 0.56; 2 RCTs; 119 participants), depth (MD -0.01 points, 95% CI -0.44 to 0.42; 2 RCTs; 119 participants), or type (MD 0.04 points, 95% CI -0.38 to 0.46; 2 RCTs; 119 participants) of corneal fluorescein staining scores. Regarding conjunctival redness, measured on a scale of 0 to 4 (lower is better), there was low-certainty evidence of little to no difference between lubricating drops and no treatment in nasal region scores (MD 0.10, 95% CI -0.29 to 0.49; 1 RCT; 73 participants) and temporal region scores (MD 0.00, 95% CI -0.39 to 0.39; 1 RCT; 73 participants). No studies reported microbial keratitis or inflammatory corneal infiltrates, and no trials reported vision-threatening adverse events up to four weeks of treatment. All trials reported the proportion of participants who discontinued participation. In two trials, no participants left any treatment group. Our meta-analysis of another two studies suggests little difference in the number of people who dropped out of the lubricating treatment group versus the no treatment group (risk ratio [RR] 1.42, 95% CI 0.19 to 10.94; 138 participants; low-certainty evidence). Lubricating drops versus saline Lubricating drops may have little to no effect compared with saline on contact lens discomfort measured on a visual analog scale of 0 to 100 (lower is better), but the evidence is very uncertain (MD 9.5 points, 95% CI -4.65 to 23.65; 1 RCT; 39 participants). No studies reported corneal fluorescein staining or conjunctival redness. No studies reported microbial keratitis or inflammatory corneal infiltrates, and no trials reported vision-threatening adverse events up to four weeks of treatment. Our meta-analysis of three studies suggests little difference in the number of people who dropped out of the lubricating treatment group versus the saline group (RR 1.56, 95% CI 0.47 to 5.12; 269 participants; low-certainty evidence). AUTHORS' CONCLUSIONS: Very low-certainty evidence suggests that lubricating drops may improve contact lens discomfort compared with no treatment, but may have little or no effect on contact lens discomfort compared with saline. Low-certainty evidence also suggests that lubricating drops may have no unwanted effects that would lead to discontinuation over one to four weeks. Current evidence suggests that prescribing lubricating drops (including saline) to people with contact lens discomfort is a viable option. However, most studies did not assess patient-reported contact lens (dis)comfort using a validated instrument. Therefore, further well-designed trials are needed to generate high-certainty evidence on patient-reported outcomes as well as on longer-term safety outcomes.

Application frequency - key indicator for the efficiency of severe dry eye disease treatment - evidence for the importance of molecular weight of hyaluronan in lubricating agents.

PURPOSE: Lubricant eye drops are the main therapeutic resource for dry eye disease (DED), with each drop representing the equivalent of ocular surface disease treatment. Thus, any reduction in the frequency of eye drop application reflects a degree of therapeutic success. Considering also the socioeconomic burden of DED, we investigated eye drop application frequency (DF) as a parameter to potentially track the success of therapy in severe DED. Hyaluronan (HA)-containing eye drops have become the first choice for tear substitution in many countries, and recent data indicate that the average molecular weight (Mw) of HA determines the therapeutic efficacy of such eye drops. This post-hoc subgroup analysis of a previously published multicentre prospective randomized open-label study, HYLAN M, is set out to compare the effects of very high Mw HA (hylan A) eye drops to comparator eye drops, containing lower Mw HA (control). METHODS: Patients with severe DED (n = 47), recruited as part of the larger HYLAN M prospective, multicentre, open-label study, were randomized into two groups: hylan A and control group. In the hylan A group, 24 patients replaced their HA-containing eye drops with eye drops containing 0.15% hylan A, whereas the 23 control patients continued to use comparator HA eye drops. The DF was recorded daily by all participants over 8 weeks, and other subjective and objective parameters of DED were assessed at the time of inclusion (baseline), as well as at week 4 and 8. RESULTS: There was a significant decrease in DF in the hylan A users between the baseline and week 4 (p = 0.004), remaining stable until week 8. Indeed, in contrast to the baseline, the hylan A group had a significantly lower DF than the control group at weeks 4 (p = 0.018) and 8 (p = 0.008). Likewise, the ocular surface disease index (OSDI) improved significantly between the time of inclusion and week 4 (p < 0.001) in hylan A users, remaining stable until week 8. The OSDI was similar in both groups at the baseline but it was significantly lower in the hylan A group than in the control group at week 4 (p = 0.002), remaining lower at week 8. Such a decrease in the DF and OSDI was not witnessed in the control group at any time point. The objective parameters assessed did not differ significantly within or between the two groups. CONCLUSION: When treating severe DED, the DF can be significantly reduced by using very high Mw HA (3 MDa) lubricant eye drops, which better alleviate DED symptoms and decrease the OSDI scores. These drops not only provide an attractive and comfortable alternative for patients with severe DED but also offer the possibility of reducing the disease's socioeconomic burden, both for affected individuals and society as a whole.

Effect of Lubricant Use on Cervicovaginal Cytology - What's the Evidence? / Efeito do uso de lubrificante na citologia cervicovaginal - Qual a evidência?

Abstract Objective To determine if the use of lubricating gel on the speculum during the cervicovaginal cytology examination interferes with the results obtained, as well as whether it reduces reported discomfort in patients. Data sources A systematic review was carried out according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) recommendations, with a search in the Pubmed/Medline, Scielo, Cochrane Library, Embase databases of articles published between January 2011 and May 2022. The keywords used were cytology, speculum, lubricant, result, and pain. Selection of studies The initial search resulted in 306 articles, of which were excluded three because they were duplicates, 257 after reading the title and abstract and 41 after reading the full text. Thus, five articles were selected for the study: four randomized clinical trials and one metanalysis. Data collection The selection of articles was performed by two investigators. The 5 selected articles were read in full and submitted to a comparative analysis. Data synthesis Screening through cervicovaginal cytology allows for early diagnosis and reduction of associated mortality, but the procedure can be associated with pain. A small amount of aqueous lubricating gel in the speculum can be used to reduce the discomfort associated with performing cervicovaginal cytology. Conclusion The use of lubricating gel in the speculum does not seem to be associated with a change in the cytology result and reduces the discomfort associated with its insertion into the vagina.

Resumo Objetivo Determinar se o uso de gel lubrificante no espéculo durante o exame de citologia cervicovaginal interfere com os resultados obtidos e se diminui o desconforto relatado por pacientes. Fontes de dados Foi realizada uma revisão sistemática segundo as recomendações do Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), com pesquisa nas bases de dados Pubmed/Medline, Scielo, Cochrane Library, Embase, de artigos publicados entre janeiro de 2011 e julho de 2022. Utilizaram-se as palavras-chave citologia, espéculo, lubrificante, resultado e dor. Seleção dos estudos A pesquisa inicial resultou em 306 artigos, dos quais foram excluídos três por se encontrarem duplicados, 257 após a leitura do título e do resumo e 41 após a leitura integral. Assim, foram selecionados cinco artigos para o estudo: quatro ensaios clínicos aleatorizados e uma metanálise. Coleta de dados A seleção dos artigos foi realizada por dois investigadores. Os cinco artigos selecionados foram lidos na íntegra e submetidos a uma análise comparativa. Síntese dos dados O rastreio através da citologia cervicovaginal permite um diagnóstico precoce e redução da mortalidade associada, mas a sua realização pode estar associada a dor. Uma pequena quantidade de gel lubrificante aquoso pode ser utilizada no espéculo para diminuir o desconforto associado à realização da citologia cervicovaginal. Conclusão A utilização de gel lubrificante não está associada a alteração do resultado da citologia e diminui o desconforto associado à sua introdução na vagina.

Management of postmenopausal vulvovaginal atrophy: recommendations of the International Society for the Study of Vulvovaginal Disease.

OBJECTIVE: To develop a best practice document for the management of postmenopausal vulvovaginal atrophy (VVA). METHOD: Literature review carried out using clinical terms, treatments or interventions and comorbidity related to VVA. RESULTS: There is a wide variety of interventions that may produce temporal benefits for VVA. However, there are significant limitations in scientific publications concerning VVA and related issues, including variable outcome evaluations, variability in population age range, and small, often underpowered sample sizes. Therapeutic management of VVA should follow a sequential order, considering women's age, symptoms, general health as well as treatment preference. Beneficial options include lubricants, moisturizers, vaginal estrogens (estradiol, estriol, promestriene, conjugated estrogens), androgens, prasterone, and laser application. In women with general menopausal symptoms who are candidates for systemic hormone therapy, the lowest effective dose should be used. Oral ospemifene is an effective selective estrogen receptor modulator to treat VVA. Systemic androgens have a limited role. Although laser procedures are commonly used, at this moment the International Society for the Study of Vulvovaginal Disease does not endorse its use out of the setting of clinical trials. Pelvic floor muscle training improves blood flow and elasticity of the vulvovaginal tissue. In breast cancer survivors, moisturizers and lubricants are first line therapy. However, limited absorption of low/ultra-low doses of estrogens suggests safety, especially in women under treatment with aromatase inhibitors. As clinical practice and available preparations vary between countries this text should be adapted to local circumstances. CONCLUSIONS: There is a wide range of therapeutic options to individualize VVA treatments.

Observational cohort study of the effect of a single lubricant exposure during transvaginal ultrasound on cell-shedding from the vaginal epithelium.

The outer layers of the vaginal epithelium (VE) are important because they accumulate glycogen which, under optimal conditions, Lactobacillus spp. consume to grow and acidify the vaginal microenvironment with lactic acid. We hypothesized that exposure to lubricant, for example in the conduct of a transvaginal ultrasound (TVUS), may contribute to the shedding of mature epithelial cells, exposing immature cells. Cervicovaginal fluid (CVF) was sampled at four time points by menstrual cup (Softdisc™) from 50 women referred for TVUS, during which a controlled volume of lubricant was applied to the TVUS wand. Samples were collected (1) immediately before TVUS and (2) 6-12 hours, (3) within one week, and (4) two weeks after TVUS. Clinical vaginal lubricants are similar to commercial lubricants, and often have a high osmolality or pH, and contain bactericides such as methylparaben and propylparaben. The number and maturity of epithelial cells in each CVF sample were measured by quantitative and differential fluorimetry (maturity index, MI). Comparisons of cell-counts and maturity were made by paired Wilcoxon signed-rank tests. Among women with a high pre-TVUS MI (> 3), there was a decrease in median cell-count and mean MI in the sample collected 6-12 hours after TVUS (p<0.001, n = 26 and p < 0.001, n = 26, respectively). For these women, cell-count and MI remained lower in the sample collected within the subsequent week (p<0.001, n = 29 and p<0.01, n = 29, respectively), and MI remained lower in the sample collected within two weeks of TVUS (p<0.01, n = 25), compared to the pre-TVUS sample. Among participants with a low pre-TVUS MI (< 3), cell-count was higher in the sample collected within two weeks of TVUS compared to the pre-TVUS sample (p = 0.03, n = 15), but no significant changes in MI were observed. Results were similar when restricted to reproductive-age women. This preliminary data indicates hypertonic vaginal lubricants may increase vaginal epithelial cell shedding.

Vaginal lubricants and moisturizers: a review into use, efficacy, and safety.

Vaginal dryness is common during and after menopause due to declining estrogen. It is one of the symptoms of vulvovaginal atrophy (VVA), which is part of the genitourinary syndrome of menopause. This can be distressing for women and cause pain, discomfort, and dyspareunia. Vaginal dryness affects over 50% of postmenopausal women but is under-reported and thus under-treated due to barriers to seeking help. Estrogen replacement can resolve symptoms, but may be contraindicated or not desired by all women. Over-the-counter vaginal moisturizers and lubricants can ease the symptoms of VVA. However, their chemical composition varies enormously and some are known to cause detrimental effects due to unphysiological pH, osmolality, and additives. The primary purpose of this review is to assess both their efficacy and safety. Women should be directed toward products that are as 'body-similar' as possible to vaginal secretions in terms of pH and osmolality. Products with potentially harmful ingredients should be avoided. Lubricants can be trialed for sexual activity and moisturizers for symptom control, even if topical or systemic menopause hormone therapy is being used.

Periurethral Lidocaine Does Not Decrease Pain After Urodynamic Testing in Women: A Double-Blinded Randomized Control Trial.

OBJECTIVE: Urodynamic testing of women is a common procedure to evaluate lower urinary tract symptoms but may cause discomfort. The objective of our study was to determine the effect of externally applied periurethral 2% lidocaine gel on pain scores after complex urodynamic testing in women. METHODS: This prospective, double-blinded, placebo-controlled randomized trial compared 2% lidocaine gel to water-based lubricant applied to the periurethral area before urodynamic testing in women. Discomfort was measured using a visual analog pain scale (VAS) ranging from 0 to 100. The primary outcome was the difference in VAS from baseline to 4 to 6 hours after urodynamic testing. Secondary outcomes included: VAS difference from baseline to immediately postprocedure and 24 hours after urodynamic testing; VAS scores: at baseline, immediately postprocedure, after 4-6 hours, and after 24 hours; urodynamic testing results; and any adverse events. Sixty-four women per group were needed to provide a power of 80% to detect a 10-mm difference on a 100-point VAS. RESULTS: From January 2018 to March 2019, 134 subjects were randomized, 6 subjects were excluded, which resulted in 64 subjects in both the water-based lubricant group and 2% lidocaine gel group. There was no difference in baseline demographics. There was no significant difference in the change in VAS from baseline to 4 to 6 hours after UDT (0, 0 P = 0.88). No difference in secondary outcomes was noted. CONCLUSIONS: Topically applied 2% lidocaine gel does not decrease pain compared with water-based lubricant. For most women, complex urodynamic testing is not associated with any significant pain.Clinical Trial Registration:www.ClinicalTrials.gov,-NCT03390790, "Lidocaine for Pain After Urodynamic Testing".

Effective reduction in inadequate Pap smears by using a saline-lubricated speculum and two glass slides.

OBJECTIVE: The aim of the study was to propose a method using saline lubrication and two glass slides to reduce the proportion of inadequate Pap smears. MATERIALS AND METHODS: This was a retrospective study of patients at a medical center in eastern Taiwan that performs 5000-6000 Pap smears annually. The extracted data only detailed the number and percentage of inadequate Pap smears. We applied two modifications to the conventional Pap smear technique. The first modification was lubricating the speculum with normal saline instead of jelly. The second modification was performing the smear on two glass slides instead of just one. We used the modified technique beginning in January 2017. Therefore, we collected data from 2016 (before the modified technique was employed) and 2018 (after the modified technique was employed). The categorical data are presented as numbers (percentages). The differences in the number and percentage of inadequate smears resulting from both techniques were assessed using the Chi-square test. RESULTS: During 2016 and 2018, 28 and 2 women received inadequate Pap smears among the total of 594 and 613 women who received Pap smears, respectively. The proportion of inadequate Pap smears was 4.71% and 0.33% in 2016 and 2018, respectively (P < 0.001). CONCLUSIONS: The use of this modified technique effectively reduced the percentage of inadequate Pap smears.

Rectal douching in a community sample of men and women.

Rectal douching (RD) may be a vector for sexually transmitted infection (STI) acquisition. The aim of this study was to describe the relationship between RD, and the prevalence of various STIs and sexual behaviors in a sample of women and men in Long Beach, California. Five hundred and forty-seven men (mean age 42.8 years) and 530 women (mean age 37 years) recruited from a community-based setting between April 2010 and August 2014 completed the Risk Behavior Assessment and a questionnaire eliciting information on use of lubricants and enemas for vaginal intercourse (VI) and anal intercourse (AI). Participants were screened for high-risk behaviors for human immunodeficiency virus infection including injection drug use. Bivariate analyses were conducted separately for women and men. Based on the empirical results, separate logistic regression models for women and men were constructed. Sensitivity analysis was conducted to assess model fit for reduced samples of only those men and women who reported AI. For men, RD was associated with a lower odds of being hepatitis C antibody positive, greater odds of being positive for hepatitis B virus surface antigen, syphilis, and using lubricants for receptive anal intercourse (RAI). RD in women was associated with higher odds of a positive test for syphilis, ever vaginally douching for VI, and using lubricants for RAI. Men and women who practice RD report positive syphilis test results and use of lubricants for RAI. RD should not be perceived as preventing STIs.

Late manifestation of follicular conjunctivitis in ventilated patient following COVID-19 positive severe pneumonia.

A 65-year-old known diabetic, hypertensive, and asthmatic patient was admitted for suspected coronavirus disease 19 (COVID-19) infection following complaints of breathlessness. He tested positive for COVID-19 and was put on ventilation. He developed severe follicular conjunctivitis of the right eye while on a ventilator, which was treated conservatively. The resolution of ocular signs was noted over 2 weeks without any complications. This case highlights the timeline of events and discusses the late ophthalmic manifestations in patients with COVID-19 infection.

Safety and Efficacy of Proctosoll Allevia in the Management of Haemorrhoidal Disease in Adults: A Prospective Randomized Clinical Trial.

INTRODUCTION: Hemorrhoidal Disease (HD) is a very common anorectal disorder that affects millions of people around the world and represents a major medical and socioeconomic problem. The aim of the present study was to assess the safety and efficacy of Proctosoll Allevia® in patients affected by symptomatic HD in comparison with the results obtained from a control group. MATERIALS AND METHODS: From January to February 2019, all the patients referred to the outpatient clinic of Rajalakshmi Hospital, who were complaining of first or second degree hemorrhoidal symptoms, were enrolled in the study. They were randomly assigned to either of the 2 arms. Group 1: patients were treated with the Proctosoll Allevia® and were under a controlled diet. Group 2: patients were only under a controlled diet without any treatment - control group. RESULTS: A total of 51 subjects were screened and 45 (13 F- 32 M) enrolled in the study. All the patients treated with topical application of the cream showed a statistically significant improvement of symptoms within 14 days from the beginning of the therapy if compared to patients who were treated only with a controlled diet. No major adverse events associated with the use of the new product were recorded. CONCLUSION: The treatment of I-II degree symptomatic HD with Proctosoll Allevia® has demonstrated to be promising with a good profile of tolerability, safety and efficacy.

Lubricant Investigation in Men to Inhibit Transmission of HPV Infection (LIMIT-HPV): design and methods for a randomised controlled trial.

INTRODUCTION: Gay, bisexual and other men who have sex with men (gbMSM) have an increased risk of human papillomavirus (HPV) infection and HPV-associated diseases, such as anal cancer and anogenital warts. A carrageenan-based lubricant could prevent HPV infection, thereby reducing the disease burden in this population. This paper describes the protocol for the Lubricant Investigation in Men to Inhibit Transmission of HPV Infection (LIMIT-HPV) study, an ongoing randomised controlled trial (RCT), evaluating efficacy of a carrageenan-based personal lubricant in reducing type-specific anal HPV incidence and prevalence among sexually active gbMSM, efficacy by HIV status, safety and tolerability of the gel and participant adherence to the intervention. METHODS AND ANALYSIS: The study is a double-blinded, placebo-controlled RCT. Volunteer gbMSM 18 years and older are randomly assigned 1:1 to receive the treatment (a self-applied anal microbicide gel with carrageenan) or placebo (a self-applied placebo gel). At each visit, computerised questionnaires are used to collect data on sociodemographic and clinical variables, lifestyle, sexual behaviour and the gels' safety and tolerability. At baseline and each follow-up visit (months 1, 2, 3, 6, 9 and 12), nurses collect anal specimens tested for 36 HPV types (linear array assay). HIV status is determined at baseline and 12 months. The primary outcome is incidence of type-specific anal HPV infection(s) undetected at baseline. Secondary outcomes are prevalence of type-specific anal HPV infection, safety, tolerability and adherence. We aim to recruit 380 participants to attain the study's objectives. Data will be analysed using intention-to-treat and per-protocol approaches with subgroup analyses by HIV status. ETHICS AND DISSEMINATION: Ethics approval was obtained by the Research Ethics Boards of McGill University, the McGill University Health Centre, Concordia University and Centre Hospitalier de l'Université de Montréal. Trial results will be disseminated through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT02354144.

Evaluation of the Efficiency of Lubricant Based on Pulmonary Surfactant in Experimental Knee Osteoarthritis in Rats: Analysis of 3D Reconstructions.

We evaluated the efficiency of a lubricant based on a pulmonary surfactant in experimental knee osteoarthritis in rats induced by intraarticular injection of abrasive material that reduces the lubricative properties of the synovial fluid. Experimental substance containing proteins of the pulmonary surfactant exhibiting natural lubricative properties was used as the lubricant. The effectiveness of the substance was analyzed by changes in morphological characteristics of the articular cartilage in 3D reconstruction images of the knee joint obtained by the method of multiple high-precision grinding. It was found that radial thickness of the articular cartilage increased and surface relief index decreased on the 6th and 12th week after administration of the substance containing surfactant proteins, which can indicate partial recovery of the articular cartilage.

EFFECT OF LUBRICANTS ON CORNEAL THICKNESS AFTER VITRECTOMY.

PURPOSE: This study examines the impact of corneal surface lubricants used during pars plana vitrectomy on corneal edema. METHODS: This prospective, observational, clinical study occurred at an academic institution. Participants were individuals aged 18 years and older who had already consented to undergo pars plana vitrectomy, without pre-existing corneal pathology. A corneal lubricant was chosen by the surgeon. Corneal thickness was measured preoperatively and postoperatively using pachymetry and anterior segment optical coherence tomography (AS-OCT). Main outcome measure was change in corneal thickness as measured by pachymetry. RESULTS: Forty-one patients completed the study protocol. The 23 subjects in the SHCS group had a significantly smaller increase in corneal thickness as measured by pachymetry compared with the 18 subjects in the HPMC group (29.9 µm vs. 58.1 µm, P value 0.02). When measured by anterior segment optical coherence tomography, the SHCS group had a smaller increase in corneal thickness compared with the HPMC group (0.04 mm vs. 0.06 mm, P value 0.09) but did not reach significance. CONCLUSION: SHCS is associated with reduced postoperative increase in corneal pachymetry as compared to HPMC.

Reducing Late Dysphagia for Head and Neck Cancer Survivors with Oral Gel: A Feasibility Study.

Dysphagia is a significant late morbidity following treatment with radiotherapy (RT) for head and neck squamous cell carcinomas (HNSCC). The purpose of this feasibility study was to test a gel-based saliva substitute to reduce the subjective assessment of dysphagia while eating food items varying in size and texture. Eligible study subjects treated with curative intended RT and suffering from dysphagia and xerostomia were recruited from the outpatient clinic during a two-month period. Nineteen subjects consented to participation and completed the EORTC QLQ-H&N35 questionnaire and three test meals. A Numeric Rating Scale (NRS) was used for subjective assessment of dysphagia during all test meals. All data on patient, tumor, and treatment characteristics were obtained from the Danish Head and Neck Cancer (DAHANCA) database. NRS data suggested reduction of dysphagia after application of the oral gel. The swallowing dysfunctions, discomfort while swallowing (p = 0.008), stuck food items (p = 0.02), and multiple attempts of clearing the throat (p = 0.05), improved significantly for soft and regular items. Both small- and large-sized food items were tested. EORTC QLQ-H&N35 showed improvement regarding eating problems (p = 0.03) and social eating (p = 0.02). No episodes of food aspiration were recorded during the test meals. Late dysphagia reduces QOL and is an important morbidity following RT. In this feasibility study, the oral gel was able to reduce dysphagia while eating soft and selected regular food items. Eating-related EORTC QLQ-H&N35 items also improved, indicating a beneficial reduction in dysphagia after application of the oral gel.

Silicone Oil Particles in Prefilled Syringes With Human Monoclonal Antibody, Representative of Real-World Drug Products, Did Not Increase Immunogenicity in In Vivo and In Vitro Model Systems.

Silicone oil is a lubricant for prefilled syringes (PFS), a common primary container for biotherapeutics. Silicone oil particles (SiOP) shed from PFS are a concern for patients due to their potential for increased immunogenicity and therefore also of regulatory concern. To address the safety concern in a context of manufacturing and distribution of drug product (DP), SiOP was increased (up to ∼25,000 particles/mL) in PFS filled with mAb1, a fully human antibody drug, by simulated handling of DP mimicked by drop shock. These samples are characterized in a companion report (Jiao N et al. J Pharm Sci. 2020). The risk of immunogenicity was then assessed using in vitro and in vivo immune model systems. The impact of a common DP excipient, polysorbate 80, on both the formation and biological consequences of SiOP was also tested. SiOP was found associated with (1) minimal cytokine secretion from human peripheral blood mononuclear cells, (2) no response in cell lines that report NF-κB/AP-1 signaling, and (3) no antidrug antibodies or significant cytokine production in transgenic Xeno-het mice, whether or not mAb1 or polysorbate 80 was present. These results suggest that SiOP in mAb1, representative of real-world DP in PFS, poses no increased risk of immunogenicity.

Clinical recommendations for use of lidocaine lubricant during bowel care after spinal cord injury prolong care routines and worsen autonomic dysreflexia: results from a randomised clinical trial.

STUDY DESIGN: Clinical trial. OBJECTIVE: Spinal cord injury (SCI) impacts autonomic function and bowel management. Bowel care is a potential trigger for autonomic dysreflexia (AD; paroxysmal hypertension elicited by sensory stimuli below the level of lesion). AD can be life threatening so strategies to minimise AD are prioritised after SCI. Lidocaine lubricant is recommended during bowel care with the rationale to minimise the sensory stimulus, reducing AD. The objective of this study was to assess whether lidocaine lubricant (Xylocaine 2%) ameliorates AD during at-home bowel care compared with standard lubricant (placebo). SETTING: Community. METHOD: Participants (n = 13; age 44.0 ± 3.3 years) with high-level SCI (C3-T4) performed their normal at-home bowel care on two days, each time using a different lubricant, with continuous non-invasive cardiovascular monitoring. Injury to spinal autonomic (sympathetic) nerves was determined from low-frequency systolic arterial pressure (LF SAP) variability. RESULTS: Participants displayed reduced autonomic function (LF SAP 3.02 ± 0.84 mmHg2), suggesting impaired autonomic control. Bowel care duration was increased with lidocaine (79.1 ± 10.0 min) compared to placebo (57.7 ± 6.3 min; p = 0.018). All participants experienced AD on both days, but maximum SAP was higher with lidocaine (214.3 ± 10.5 mmHg) than placebo (196.7 ± 10.0 mmHg; p = 0.046). Overall, SAP was higher for longer with lidocaine (6.5 × 105 ± 0.9 × 105 mmHg • beat) than placebo (4.4 × 105 ± 0.6 × 105 mmHg • beat; p = 0.018) indicating a higher burden of AD. Heart rate and rhythm disturbances were increased during AD, particularly with lidocaine use. CONCLUSIONS: At-home bowel care was a potent trigger for AD. Our findings contradict recommendations for lidocaine use during bowel care, suggesting that anaesthetic lubricants impair reflex bowel emptying, resulting in longer care routines with an increased burden of AD.

Vaginal Health in Menopausal Women.

The aim of this review is to provide an overview of genitourinary health in peri- and postmenopause, particularly of vulvovaginal atrophy (VVA), which is part of genitourinary syndrome (GSM). This condition has a high prevalence among post-menopausal women and negatively affects a woman's quality of life. Epidemiology, signs, symptoms, diagnostic criteria of VVA and target treatments for restoring vaginal health are discussed in light of the most recent literature. Issues related to this condition in menopausal women are under-diagnosed, lack objective diagnostic criteria, and consequently under-treated. Over the years, many treatments have been developed but their long-term effectiveness and safety have yet to be clearly defined. Patients are often dissatisfied and stop treatment, suggesting the need for a more personalized and tailored approach to achieve better compliance and thereby effectiveness. The aim of this paper is to provide an overview of the most recent literature on VVA in order to help the gynecologist in the management of this condition.

Lidocaine lubricants for intubation-related complications: a systematic review and meta-analysis.

PURPOSE: Postoperative sore throat (POST) is a relatively common morbidity. Topical lidocaine lubricants have been proposed to prevent POST; however, their effectiveness remains uncertain. This meta-analysis aimed to evaluate the prophylactic effect of lidocaine lubrications against POST, cough, and hoarseness in adult patients after surgery. METHODS: Randomized-controlled trials from PubMed, Embase, the Cochrane Library, and the ClinicalTrials.gov registry that were published from inception until 26 March 2018 were included that compared the effectiveness of lidocaine lubricants with that of controls in preventing the incidence of overall POST and moderate to severe POST (POSTMS) at the first and 24th postoperative hour (POST-1h, POST-24h, POSTMS-1h, and POSTMS-24h). Postoperative cough and hoarseness at the 24th postoperative hour were also studied. Bias assessment and subgroup, sensitivity, and trial sequential analyses were also performed. RESULTS: Fourteen randomized-controlled trials (n = 2146) were selected. The incidences of POST-1h and POST-24h were 41.1 % and 22.6 % for the lidocaine group, and 41.9% and 23.5% for the control group, respectively. No effect was found on any of the outcome measurements. The overall risk ratios were 1.11 (95% confidence interval [CI], 0.82 to 1.51) and 1.06 (95% CI, 0.37 to 3.02) for the incidence of POST-1h and POSTMS-1h, respectively; 0.99 (95% CI, 0.83 to 1.17) and 0.49 (95% CI, 0.16 to 1.50) for POST-24h and POSTMS-24h, respectively; and, 1.09 (95% CI, 0.71 to 1.66) and 0.91 (95% CI, 0.66 to1.24) for postoperative cough (PC)-24h and postoperative hoarseness (PH)-24h, respectively. CONCLUSION: Lidocaine lubricants applied on the tips of endotracheal tube are not effective against the morbidities of POST, PC, and PH. TRIAL REGISTRATION: PROSPERO (CRD42017073259); registered 26 October, 2017.

RéSUMé: OBJECTIF: Les maux de gorge postopératoires sont une morbidité relativement fréquente. Les lubrifiants topiques à base de lidocaïne ont été proposés pour prévenir les maux de gorge postopératoires, mais leur efficacité demeure incertaine. Cette méta-analyse avait pour objectif d'évaluer l'effet prophylactique des lubrifications de lidocaïne contre les maux de gorge postopératoires, la toux et l'enrouement de la voix chez les patients adultes après une chirurgie. MéTHODE: Nous avons inclus les études randomisées contrôlées publiées sur PubMed, Embase, la Cochrane Library et le registre de ClinicalTrials.gov entre leur création et le 26 mars 2018 qui comparaient l'efficacité des lubrifiants à base de lidocaïne par rapport à l'absence de traitement pour prévenir l'incidence des maux de gorge postopératoires globaux et des maux de gorge postopératoires modérés à graves à la première et à la vingt-quatrième heure postopératoire (POST-1h, POST-24h, POSTMS-1h, et POSTMS-24h). La toux et l'enrouement à 24 heures postopératoires ont également été étudiés. Des analyses d'évaluation du biais et de sous-groupe, de sensibilité et des analyses séquentielles d'essais ont également été réalisées. RéSULTATS: Quatorze études randomisées contrôlées (n = 2146) ont été sélectionnées. Les incidences de POST-1h et de POST-24h étaient de 41,1 % et 22,6 % dans le groupe lidocaïne, et de 41,9 % et 23,5 % dans le groupe témoin, respectivement. Aucun effet n'a été observé pour aucun de nos critères d'évaluation. Les rapports de risque globaux étaient de 1,11 (intervalle de confiance [IC] 95 %, 0,82 à 1,51) et de 1,06 (IC 95 %, 0,37 à 3,02) pour l'incidence de POST-1h et de POSTMS-1h, respectivement; de 0,99 (IC 95 %, 0,83 à 1,17) et de 0,49 (IC 95 %, 0,16 à 1,50) pour les POST-24h et POSTMS-24h, respectivement; et de 1,09 (IC 95 %, 0,71 à 1,66) et 0,91 (IC 95 %, 0,66 à 1,24) pour la toux postopératoire (PC)-24h et l'enrouement postopératoire (PH)-24h, respectivement. CONCLUSION: Les lubrifiants à base de lidocaïne appliqués sur l'extrémité distale du tube endotrachéal ne sont pas efficaces pour prévenir les morbidités de maux de gorge, de toux et d'enrouement postopératoires. ENREGISTREMENT DE L'éTUDE: PROSPERO (CRD42017073259); enregistrée le 26 octobre 2017.