Improved Signs and Symptoms of Dry Eye Disease for Restasis® Patients Following a Single Tearcare® Treatment: Phase 2 of the SAHARA Study.

Purpose: To evaluate dry eye disease (DED) signs and symptoms six months after a single treatment with Localized Heat Therapy (LHT) (TearCare, Sight Sciences) for patients previously treated for six months with cyclosporine (0.05%) ophthalmic emulsion (CsA) BID (Restasis, Allergan). Setting: Nineteen ophthalmic and optometric practices in 11 US states. Design: Multicenter, cross-over, six month extension to the SAHARA randomized, controlled trial (RCT). Included patients were those randomized to CsA in Phase 1 of the SAHARA RCT. Methods: This was the second phase of the SAHARA RCT in which, following the 6-month endpoint, all patients that had been randomized to CsA discontinued CsA and were treated with LHT and subsequently followed for an additional six months. Outcome measures at 12 months for CsA patients crossed over to LHT included TBUT, OSDI and MGSS. Results: One hundred and sixty-one patients (322 eyes) were analyzed. Mean (SD) baseline TBUT prior to CsA was 4.4 (1.2) seconds, 5.6 (2.6) at 6 months which improved to 6.6 (3.2) and 6.1 (2.8) seconds (both P < 0.001) at 9 and 12 months (3, 6 months post LHT). Mean (SD) OSDI was 50.0 (14.9) at baseline and 34.2 (21.5) after CsA. With LHT at 6 months, this improved to 30.0 (20.6) and 31.0 (19.5) at 9 and 12 months (P = 0.162 vs month 6, P < 0.0001 vs baseline). MGSS was 7.1 (3.2) at baseline, 13.3 (8.2) at the end of CsA treatment which improved to 17.4 (8.8) and 16.1 (9.0) at 9 and 12 months; both P <0.001. Conclusion: SAHARA showed 6-month superiority of LHT to CsA in clinical signs and non-inferiority in symptom scores. This extension shows that patients treated with CsA for 6 months can achieve meaningful additional improvement in signs and symptoms lasting for as long as 6 months following a single LHT treatment without the need for topical prescription therapy.

A Randomized, Controlled Trial Comparing Tearcare® and Cyclosporine Ophthalmic Emulsion for the Treatment of Dry Eye Disease (SAHARA).

Purpose: We compare outcomes in eyes with dry eye disease (DED) treated with TearCare (TC) or topical cyclosporine 0.05% (RESTASIS; CsA). Setting: Nineteen ophthalmic and optometric practices in 11 US states. Design: Multicenter, randomized, assessor-masked, controlled IRB-approved trial. Eligible subjects: ≥22 years of age, dry eye symptoms within 3-6 months, Tear Break-up Time (TBUT) ≥1 to ≤7 s, Meibomian Gland Secretion Score (MGSS) ≤12, Ocular Surface Disease Index (OSDI) of 23-79. Randomized (1:1) to TC or CsA. TC subjects treated at baseline and month 5; CsA was twice daily for 6 months. Methods: Follow-up visits were scheduled for Day 1, Week 1, Months 1, 3, and 6 with primary inference at Month 6. Primary outcomes: TBUT and OSDI; secondary outcomes: MGSS, conjunctival and corneal staining, eye dryness score (EDS), symptoms assessment in dry eye (SANDE) score, and Schirmer tear score (STS). Safety assessments included adverse events, best corrected visual acuity, intraocular pressure, and slit-lamp findings. Results: Overall, 345 subjects, 172 TC and 173 CsA. TBUT improved at all time points in both groups (p<0.0001), with statistically greater improvement for TC versus CsA (p=0.0006). OSDI improved significantly at all time points in both groups (p<0.0001) with no significant differences between treatments. MGSS and other measures of meibomian gland function improved significantly more with TC eyes versus CsA; other secondary outcomes showed significant improvements in both groups with no difference between groups. Treatment-related adverse events were uncommon (10 total, 8 in the CsA group consistent with prior CsA studies); most (9/10) mild. Conclusion: TC provides statistically superior and sustained improvement in TBUT and multiple measures of meibomian gland secretion, and non-inferior improvement in OSDI, corneal and conjunctival staining, SANDE, EDS, and STS versus CsA. TC should be a preferred treatment for DED associated with MGD.

To complain or not to complain: Management responses as a moderator in the relationship between workplace incivility and workplace outcomes among Australia and singaporean targets.

Workplace incivility is a challenging global occupational risk that is frequently considered trivial by managers and organizations. Often, complaints from targets are ignored; when this occurs, complaints can quickly escalate into formal grievances that cost businesses millions of dollars. While existing studies have uncovered cultural and gendered differences in how targets and organizations respond to workplace incivility, few cross-cultural studies have empirically examined how targets and organizations react to formal complaints. This study responds to this gap by using selective incivility, the transactional stress model, and national/cultural theories to conduct a multifaceted analysis of the underlying mechanisms responsible for targets' organizational outcomes. Specifically, we tested a moderated model with 303 Australian (152 males and 151 females) and 304 Singaporean (154 males and 150 females) employees working in multinational organizations to determine whether the degree to which organizations took incivility complaints seriously moderated the organizational outcomes of work withdrawal and work satisfaction. Overall, the results indicated that, compared to Singaporean employees and Australian female employees, Australian male employees were less tolerant of being mistreated and continued to experience heightened job dissatisfaction and withdrawal even when their complaints were taken seriously by their organization. These results suggest that complex gendered and cultural differences influence the impact of incivility complaints on work-related outcomes.

A Comparison of TearCare and Lipiflow Systems in Reducing Dry Eye Disease Symptoms Associated with Meibomian Gland Disease.

Purpose: To compare TearCare and Lipiflow systems in the ability to reduce the symptoms of dry eye disease (DED) associated with meibomian gland dysfunction (MGD). Methods: In this multicenter, masked, randomized-controlled trial, 235 subjects received a single TearCare treatment (n = 115) or a single LipiFlow treatment (n = 120) and were followed for 1-month post-treatment. DED symptoms were assessed using the Ocular Surface Disease Index (OSDI), Symptom Assessment in Dry Eye (SANDE), and Eye Dryness (ED) questionnaires at baseline and at 1 month. Post-hoc subgroup analysis was conducted on subjects with less severe and more severe gland obstruction determined by baseline meibomian gland secretion score (MGSS). Results: TearCare system significantly improved total OSDI, SANDE, and ED scores from baseline (p < 0.0001) at 1-month follow-up. Subjects with more severe disease (MGSS <7) achieved statistically greater reduction with TearCare compared to LipiFlow in total OSDI score (30.4 ± 2.53 and 21.9 ± 2.37, respectively, p ANCOVA = 0.0160), OSDI Section B score for quality of vision (5.1 ± 0.48 and 3.6 ± 0.45, respectively, p ANCOVA= 0.0206), and SANDE frequency score (51.9 ± 3.70 and 41.5 ± 3.45, respectively, p ANCOVA = 0.0455). Conclusion: TearCare provides significant DED symptom relief at 1 month after a single treatment. Outcomes were consistent in OSDI, SANDE, and ED assessments. In subjects with more severe gland dysfunction, TearCare performed significantly better than LipiFlow in improving quality of vision and overall DED symptom frequency determined by OSDI and SANDE. Clinical Trial Registration Number: NCT03857919.

Lashing out: emotional exhaustion triggers retaliatory incivility in the workplace.

Incivility in the workplace is a growing problem in many workplaces that can detrimentally affect employees and organisations. Despite this increasing problem, the current literature on incivility lacks an integrated theoretical model to explain engaged and retaliated incivility in the workplace. To address this gap, we tested a model which incorporated both Spiral Theory of Incivility with Conservation of Resource Theory to explain the underlying processes involve in the relationship between engaged and retaliatory workplace incivility. Specifically, retaliatory incivility was hypothesised as an influencing factor, work withdrawal and job dissatisfaction as consequences, and emotional exhaustion as a moderator. A total of 875 employees in multinational organisations across three countries were panel surveyed. The overall result from the Structural Equation Modelling (SEM) indicated that the fit indices for the proposed model fulfilled all recommended levels. Importantly, emotional exhaustion was found to be the trigger point in the negative spiral of workplace incivility. Theoretical implications and practical considerations were discussed.

TearCare for the Treatment of Meibomian Gland Dysfunction in Adult Patients With Dry Eye Disease: A Masked Randomized Controlled Trial.

PURPOSE: The aim of this study was to demonstrate the safety and effectiveness of a single TearCare procedure compared with a single LipiFlow procedure in treatment of the dry eye disease associated with meibomian gland dysfunction. METHODS: In a multicenter, masked, randomized controlled trial, 135 subjects received a single TearCare (TC) treatment (n = 67) or a single LipiFlow (LF) treatment (n = 68) at baseline and were followed up for 1 month posttreatment. Tear film breakup time, meibomian gland function, and corneal and conjunctival staining scores were assessed as dry eye signs at baseline, 2 weeks, and 1 month; dry eye symptoms were assessed using the Ocular Surface Disease Index, Symptom Assessment in Dry Eye, and eye dryness questionnaires at baseline and 1 month. RESULTS: At 1 month posttreatment, both groups demonstrated significant improvements (P < 0.0001) in mean tear film breakup time and meibomian gland secretion score to 3.0 ± 4.4 and 11.2 ± 11.1 in the TC group and 2.6 ± 3.3 and 11.0 ± 10.4 in the LF group, respectively. The mean eye dryness, Symptom Assessment in Dry Eye, and Ocular Surface Disease Index scores were significantly reduced (P < 0.0001) by 35.4 ± 34.1, 38.2 ± 31.0, and 27.9 ± 20.5 in the TC group and 34.9 ± 26.9, 38.0 ± 25.9, and 23.4 ± 17.7 in the LF group, respectively. There were no statistically significant differences for any result between the groups. However, the TC group demonstrated numerically greater improvements consistently in all signs and symptoms. Device-related ocular adverse events were reported in 3 patients in the TC group (superficial punctate keratitis, chalazion, and blepharitis) and 4 patients in the LF group (blepharitis, 2 cases of foreign body sensation, and severe eye dryness). CONCLUSIONS: A single TearCare treatment significantly alleviates the signs and symptoms of dry eye disease in patients with meibomian gland dysfunction and is equivalent in its safety and effectiveness profile to LipiFlow treatment as shown in this 1-month follow-up study.

Dry Eye Treatment with Topical Cyclosporine 0.1% in Chondroitin Sulfate Ophthalmic Emulsion.

PURPOSE: To evaluate the efficacy of topical cyclosporine 0.1% in chondroitin sulfate emulsion for the treatment of dry eye. METHODS: This retrospective multicenter study included 100 eyes of 50 dry eye patients aged ≥18 years, with preoperative ocular surface disease index (OSDI) score >12 or corneal staining grade >1 (in either eye) who underwent dry eye treatment with topical cyclosporine 0.1% in chondroitin sulfate emulsion (Klarity-C, ImprimisRx) for 3 months. Postoperative evaluation included comparison of the changes in OSDI score and corneal staining grade after 3 months of treatment from baseline. RESULTS: From baseline to 3 months, a statistically significant improvement in mean OSDI scores (38.19 vs 24.18, p <0.001) as well as mean corneal staining grade (3.62 vs 2.20, p <0.001) was observed. The proportion of subjects with severe dry eye decreased from 62% to 20% and more than one-third (34%) of patients were in the normal OSDI range. The percentage of eyes with corneal staining grade of 2 or 3 decreased from 21% (baseline) to 8% at 3 months; 50% of the eyes had corneal staining grade of 0. The treatment was found to be safe with no adverse events observed in the study. CONCLUSION: Dry eye treatment with twice daily cyclosporine 0.1% in chondroitin sulfate emulsion was found to be safe and effective in reducing signs and symptoms of dry eye.

To Stay in or Leave an Abusive Relationship: Losses and Gains Experienced by Battered Filipino Women.

The present study aimed to describe and analyze the losses and gains experienced by battered Filipino women as a result of their decision to stay in or leave an abusive relationship. In-depth, semistructured interviews were conducted with 60 battered women, 30 of the women were still living with their abusive husbands/partners and 30 have left their abusive husbands/partners. Results from the phenomenological data analysis of the qualitative data revealed that the women who stayed in and left their abusive partners experienced both losses and gains. For the women who stayed in an abusive relationship, they lost a sense of self, the opportunity for a better life, peace of mind, psychological well-being, and love for their partners. However, these women had the benefits of having a complete family and a partner to help raise their children. In contrast, despite not having a complete family or a partner to help them raise their children, women who left an abusive relationship gained back their sense of self, peace of mind, freedom, inner strength, and hope. Implications for counseling practice were discussed.

Effects of Parental Stress, Optimism, and Health-Promoting Behaviors on the Quality of Life of Primiparous and Multiparous Mothers.

BACKGROUND: Parental stress, optimism, and health-promoting behaviors (HPBs) are important predictors of the quality of life (QoL) of mothers. However, it is unclear how strongly these predictors affect the QoL of mothers. It is also unclear if the impact of these predictors on QoL differs between primiparous and multiparous mothers. In this study, we defined primiparous as "bearing young for the first time" and multiparous as "having experienced one or more previous childbirths." OBJECTIVES: The first objective of this study was to examine the relative effect of parental stress, optimism, and HPBs on the QoL of mothers. The second objective was to investigate if the effect of these predictors differed between primiparous and multiparous mothers. METHODS: One hundred ninety-four Australian mothers (n = 87, 44.8% primiparous mothers) participated in an online survey that included the Parental Stress Scale, the Health-Promoting Lifestyle Profile II, the Revised Life Orientation Test, and the Quality of Life Enjoyment and Satisfaction Questionnaire. RESULTS: All predictors (parental stress, optimism, and HPBs) significantly affected the QoL of mothers; higher levels of optimism, greater use of HPBs, and lower parental stress were associated with higher levels of QoL for all mothers. Parity did not affect the relationships. DISCUSSION: This study sheds light on the nature and unique effect of parental stress, optimism, and HPBs on the QoL of mothers.

Factors associated with battered Filipino women's decision to stay in or leave an abusive relationship.

There is a dearth of research on battered Filipino women's stay or leave decision-making process. The present study interviewed 40 battered women in the Philippines to explore factors associated with their decisions to stay or leave their husbands or partners. Results revealed that (a) battered women's decision to stay was associated with intrapersonal and interpersonal factors such as personality characteristics, lack of personal resources, absence of social support, presence of children, length of relationship, and sociocultural factors and (b) battered women's decision to leave their abusive partners was associated with factors such as personality characteristics, personal resources, social support, nature of abuse, and spousal factors. Implications for research and practice were discussed.

Words that hurt: a qualitative study of s parental verbal abuse in the Philippines.

This article investigated opinions on what constitute parental abuse with interviews of 30 high school students, 30 parents, and 28 counselors. Despite increased reported cases of emotional abuses and child maltreatments in the Philippines, few empirical studies have explored the exact nature of parental verbal abuses in this country. This study is designed to address this gap in the literature. The results revealed nine categories of parental verbal abuses namely: (a) Put downs and shaming, (b) Rejection, (c) Blaming, (d) Fault Exaggerating, (e) Threat, (f) Invoking harm, (g) Regrets, (h) Unfair comparison, and (i) Negative prediction. Implications for research and practice were discussed.

The role of optimism in health-promoting behaviors in new primiparous mothers.

BACKGROUND: Perceived stress has been associated with fewer health-promoting behaviors in new primiparous mothers, but less is known about the mechanisms responsible for such effects. OBJECTIVE: The objective of this study was to examine the hypothesis that the relationship between perceived stress and health-promoting behaviors is mediated partially by a primiparous mother's sense of optimism. The transactional model of stress and coping and the model of behavioral self-regulation were used as the theoretical framework for the study. METHODS: An ex post facto cross-sectional design was used for this study. Participants consisted of 174 primiparous mothers who had given birth within the previous 12 months. Participants completed a self-reported online questionnaire consisting of the Perceived Stress Scale, the Health-Promoting Lifestyle Profile II, and the revised Life Orientation Test. RESULTS: Results indicated that perceived stress predicted less health-promoting behaviors in new primiparous mothers (p < .001). Importantly, this relationship was mediated partially by the optimism displayed by the mother (p < .001). CONCLUSIONS: The findings indicated that optimism partially mediated the relationship between perceived stress and health-promoting behaviors in new primiparous mothers. The implications for psychological practice are discussed.

Timing of levothyroxine administration affects serum thyrotropin concentration.

CONTEXT: Patients treated with levothyroxine typically ingest it in a fasting state to prevent food impairing its absorption. The serum thyrotropin concentration is the therapeutic index of levothyroxine action. OBJECTIVE: The study objective was to determine the effect of the timing of levothyroxine administration in relationship to food on serum thyrotropin levels. DESIGN: Participants were randomized to one of six sequences, each consisting of three 8-wk regimens in a three-period crossover design. These regimens were in a fasting state, at bedtime, and with breakfast. The concentrations of TSH, free T(4), and total T(3) during each of the three timing regimens were documented. The primary outcome was the difference between serum TSH concentrations under fasting conditions compared with concentrations during the other 8-wk regimens. SETTING: The study was conducted in an academic medical center. PARTICIPANTS: Study participants were receiving levothyroxine for treatment of hypothyroidism or thyroid cancer. RESULTS: Sixty-five patients completed the study. The mean thyrotropin concentration was 1.06 +/- 1.23 mIU/liter when levothyroxine was administered in the fasting state. When levothyroxine was taken with breakfast, the serum thyrotropin concentration was significantly higher (2.93 +/- 3.29 mIU/liter). When levothyroxine was taken at bedtime, the serum TSH concentration was also significantly higher (2.19 +/- 2.66 mIU/liter). CONCLUSION: Nonfasting regimens of levothyroxine administration are associated with higher and more variable serum TSH concentrations. If a specific serum TSH goal is desired, thereby avoiding iatrogenic subclinical thyroid disease, then fasting ingestion of levothyroxine ensures that TSH concentrations remain within the narrowest target range.

The magnitude of increased levothyroxine requirements in hypothyroid pregnant women depends upon the etiology of the hypothyroidism.

BACKGROUND: In the United States, many women with hypothyroidism are on thyroid hormone replacement during pregnancy. The optimal management strategy for thyroid hormone dosing in hypothyroid women during pregnancy is controversial. We hypothesized that dosage requirements during pregnancy might differ depending upon the nature of the underlying hypothyroidism. METHODS: We conducted a retrospective review of 45 pregnancies from 38 women whose hypothyroidism was managed during pregnancy. Thyroid function tests were obtained when pregnancy was confirmed, then every 4-8 weeks. The thyrotropin (TSH) goal was 0.4-4.1 microU/mL (SI unit conversion: multiply TSH by 1.0 for mIU/L). RESULTS: On average, the entire group required a cumulative increase from baseline in levothyroxine (LT(4)) dosage of 13% in the first trimester, 26% in the second trimester, and 26% in the third trimester (p < 0.001, p < 0.001, p < 0.001, respectively). Average baseline LT(4) dose for patients with primary hypothyroidism was 92.5 +/- 32.0 microg daily. These patients required small cumulative dose increases of 11%, 16%, and 16% from baseline in each trimester, respectively (p values = 0.125, 0.016, 0.016). Average baseline LT(4) dose for patients with hypothyroidism resulting from treated Graves' disease or goiter was 140.4 +/- 62.4 microg daily. These patients required the largest cumulative increases in LT(4) dosage (first trimester, 27%; second trimester, 51%; third trimester, 45%; p = 0.063, 0.063, 0.063, respectively). Average baseline LT(4) dose for patients with thyroid cancer was 153.2 +/- 30.3 microg. The cumulative LT(4) dose increases for patients with thyroid cancer were 9%, 21%, and 26% in each trimester, respectively (p = 0.03, p < 0.001, p < 0.001). CONCLUSIONS: The etiology of hypothyroidism plays a pivotal role in determining the timing and magnitude of thyroid hormone adjustments during pregnancy. Patients require vigilant monitoring of thyroid function upon confirmation of conception and anticipatory adjustments to LT(4) dosing based on the etiology of their hypothyroidism.

Literature review and meta-analysis of topical carbonic anhydrase inhibitors and ocular blood flow.

The purpose of this literature review and meta-analysis was to determine what, if any, effects topical carbonic anhydrase inhibitors have on ocular hemodynamics in humans. A literature review and meta-analysis was conducted to investigate the effects of topical carbonic anhydrase inhibitors on ocular blood flow. Thirty-five articles were evaluated according to the inclusion criteria with 13 manuscripts meeting requirements for statistical analysis. Each study's effect size, defined as the change in blood flow measures after treatment with topical carbonic anhydrase inhibitors, was estimated using the weighted mean difference. Based on this meta-analysis, we conclude that topical carbonic anhydrase inhibitors increase ocular blood flow velocities in the retinal circulation, central retinal and short posterior ciliary arteries, but not in the ophthalmic artery.

Disorders of water and salt metabolism associated with pituitary disease.

Disorders of water and sodium homeostasis are very common problems encountered in clinical medicine. Disorders of water metabolism are divided into hyperosmolar and hypoosmolar states, with hyperosmolar disorders characterized by a deficit of body water in relation to body solute and hypoosmolar disorders characterized by an excess of body water in relation to total body solute. This article briefly reviews the physiology of hyperosmolar and hypoosmolar syndromes, then focuses on a discussion of the pathophysiology, evaluation, and treatment of specific pre- and postoperative disorders of water metabolism in patients with pituitary lesions.

Diabetes insipidus as a complication after pituitary surgery.

BACKGROUND: A 28-year-old woman presented with new-onset vertigo and diplopia that had started 2 weeks previously. An MRI scan of the brain revealed an 11 x 9 x 9 mm sellar mass that extended into the suprasellar region. Evaluation of pituitary function showed mild central hypothyroidism and secondary adrenal insufficiency. The patient underwent trans-sphenoidal resection of the mass without any significant intraoperative complications. On postoperative day 1 she abruptly developed polyuria, hypernatremia and urine hypo-osmolality. INVESTIGATIONS: Measurements of plasma and urine osmolality, urine specific gravity, and serum sodium levels. DIAGNOSIS: Postoperative diabetes insipidus with a triphasic pattern. MANAGEMENT: The patient's diabetes insipidus was initially treated with intravenous desmopressin, and her fluid status, serum sodium levels, and serum and urine osmolality were carefully monitored. During the second, antidiuretic phase, desmopressin was discontinued and the patient's fluid intake was restricted. After recurrence of diabetes insipidus during the third phase, the patient was treated with intranasal desmopressin and was discharged. She remains on desmopressin therapy for chronic diabetes insipidus.

Total parenteral nutrition in management of hyperlipidemic pancreatitis during pregnancy.

OBJECTIVE: To describe a case of severe gestational hyperlipidemic pancreatitis successfully managed with minimal-lipid-containing parenteral nutrition (PN) followed by a minimal-fat diet, which resulted in delivery of a healthy full-term neonate. METHODS: We present the case of a young woman with gestational hyperlipidemic pancreatitis whose management included the use of PN during pregnancy. In addition, we review the literature pertaining to the management of hyperlipidemic pancreatitis during pregnancy and discuss the role for PN. RESULTS: A 32-year-old gravida 2, para 1 woman at 27 weeks 3 days of gestation presented with 1 day of nausea, bilious emesis, and severe abdominal pain caused by pancreatitis attributable to hypertriglyceridemia. Her initial serum triglyceride concentration was 9,450 mg/dL. She received fluids intravenously and minimal-lipid PN until resolution of her symptoms. The serum triglyceride level remained less than 850 mg/dL during administration of PN. She subsequently tolerated a minimal-fat diet, while the serum triglyceride level was maintained at less than 1,400 mg/dL, until delivery of a full-term, healthy neonate. CONCLUSION: In severe gestational hyperlipidemic pancreatitis, PN offers a safe and flexible treatment option by providing pancreatic rest and controlling serum triglyceride concentrations while maintaining fetal and maternal nutritional support.