Ocular Symptom Score Research Articles

Onset of action for loratadine tablets for the symptomatic control of seasonal allergic rhinitis in adults challenged with ragweed pollen in the Environmental Exposure Unit: a post hoc analysis of total symptom score

BackgroundLoratadine is a second-generation, non-sedating antihistamine used for the relief of allergic rhinitis symptoms. Previous studies reported that when loratadine was encapsulated, the onset of action for symptom relief was 180 min. However, unmodified loratadine tablets were not evaluated at that time. Using data from a previously published Environmental Exposure Unit (EEU) study comparing azelastine nasal spray with loratadine tablets, cetirizine tablets, and placebo, this post hoc analysis determines the onset of action of loratadine tablets (i.e. unmodified) by analyzing the total symptom score for the relief of nasal and ocular seasonal allergic rhinitis (SAR) symptoms.MethodsA Phase IV, randomized, single-center, double-blind, placebo-controlled, double-dummy, four-way crossover study was conducted in the EEU. Seventy participants were randomized sequentially into one of the four treatments during ragweed pollen exposure. Nasal and ocular symptom scores were self-reported by the participants and recorded. The original study analysis was carried out by evaluating the nasal symptom scores only. For this post hoc analysis, both nasal and ocular data from the loratadine and placebo treatment arms were analyzed. The primary endpoint for this analysis was the onset of action of loratadine as measured by the change in total symptom score (TSS) from baseline in comparison to placebo. The onset of ocular symptom relief using the total ocular symptom score (TOSS) was also reported.ResultsLoratadine tablets demonstrated a significant and durable improvement in both TSS (P = .005) and TOSS (P = .013) at 75 min post-treatment administration compared to placebo. The mean proportion of participants reporting none or mild for all component symptoms of TSS and TOSS at 75 min and thereafter was significantly higher in the loratadine (TSS, P = .0005; TOSS, P ≤ .0001) vs. placebo treatment arm.ConclusionsThe onset of action of loratadine tablets was 75 min for the relief of nasal and ocular symptoms in adults with SAR. These results suggest a faster onset of action for loratadine tablets (75 min) compared to previously reported studies which were conducted with modified (i.e. gelatin-encapsulated) loratadine tablets (180 min).Trial registration Clinicaltrials.gov identifier NCT00561717

Effect of a Novel Photoelectrochemical Oxidation Air Purifier on Nasal and Ocular Allergy Symptoms.

BackgroundPhotoelectrochemical oxidation (PECO) is a new air purification technology developed to reduce circulating indoor allergens. PECO removes particles as small as 0.1 nm with the destruction of organic matter otherwise not trapped by a traditional filter and removes volatile organic compounds.ObjectiveWe hypothesized that with daily use, the device would reduce user nasal and ocular allergy total symptom scores (TSS) within 4 weeks.MethodsThe study was performed among 46 individuals with self-reported allergies using a portable PECO air purifier. Self-reported TSS were calculated at baseline and weekly for 4 weeks following initiation of continuous use of the system. TSS was the sum of total nasal symptom scores (TNSS) and total ocular symptom scores (TOSS) for the week.ResultsThere was a statistically significant change in overall TSS from baseline to 4 weeks (10.1 at baseline and 4.35 postintervention) resulting in a mean difference of 5.75 (95% confidence interval [CI] 4.32–7.18; P < .0001). There was a statistically significant change in TNSS from baseline to 4 weeks (6.3 at baseline and 3.04 postintervention) resulting in a mean difference of 3.26 (95% CI 2.33–3.19; P < .0001). There was a statistically significant change in TOSS from baseline to 4 weeks (3.82 at baseline and 1.3 postintervention) resulting in a mean difference of 2.52 (95% CI 1.74–3.3; P < .0001).ConclusionWith the use of PECO air purification technology, TSS, TNSS, and TOSS decreased significantly. These improvements were consistent over the 4-week course of device use.

P431 Novel photo-electrochemical oxidation air-purifiication technology reduces nasal and ocular allergy symptoms

Photo-electrochemical oxidation (PECO) is a new air purification technology developed to reduce circulating indoor allergens. PECO removes particles as small as 30 nanometers with the destruction of organic matter otherwise not trapped by a traditional filter and removes volatile organic compounds. We hypothesized that with daily use, the device would reduce user nasal and ocular allergy total symptom scores within 4 weeks.

A randomized study comparing the efficacy of mometasone furoate and fluticasone furoate on the ocular and nasal symptoms of allergic rhinitis

&lt;p class="abstract"&gt;&lt;strong&gt;Background:&lt;/strong&gt; Ocular symptoms like itching, redness and congestion are common in patients with allergic rhinitis. These symptoms affect the quality of life and increase the burden on the healthcare cost. Intranasal steroids are effective in reducing the nasal and ocular symptoms of allergic rhinitis. We aim to compare the efficacy of mometasone furoate nasal spray and fluticasone furoate nasal spray in reducing the nasal and ocular symptoms of allergic rhinitis.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Methods:&lt;/strong&gt; 90 patients with perennial allergic rhinitis and ocular symptoms were randomly divided into 2 groups. Group A (n=46) received 200 µg of mometasone furoate nasal spray once daily and Group B (n=44) received 110 µg of fluticasone furoate nasal spray daily. The patients were assessed by total ocular symptom score [TOSS] and total nasal symptom score [TNSS] at 2, 6 and 12 weeks interval. &lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Results:&lt;/strong&gt; There was a statistically significant reduction in both the groups in respect to the TOSS and TNSS scores. However the improvement in the TOSS score in the fluticasone furoate group was more than the mometasone furoate group by 6 weeks (p=0.0009), which continued till the 12 weeks (p=0.045).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions:&lt;/strong&gt; Fluticasone furoate is more effective than mometasone furoate in managing the ocular and nasal symptoms of allergic rhinitis. &lt;/p&gt;

Allergic rhinitis management:environment control and patient education

Objective:To observe the auxiliary curative effect of combined clostridium and bifidobacterium capsules, live (also called Changlekang) in the treatment of allergic rhinitis by comparing IL-10, transforming growth factor-β1(TGF-β1), the quality of life score and symptom score before and after oral Changlekang.Method:Twenty qualified patients in the study group and 20 qualified patients in the control group were enrolled.The study group was given changlekang, desloratadine citrate disodium tablets and mometasone furoate nasal spray for treatment. After 2 weeks of treatment, Changlekang was still given for maintenance therapy for 6 weeks, and no other two kinds of drugs. The control group was given the desloratadine citrate disodium tablets and mometasone furoate nasal spray for 2 weeks and then quited the clinical trials. The changes of symptom score, quality of life score, serum IL-10, serum TGF-β1 would be statistically analyzed during the treatment.Result:①Before treatment, serum TGF-β1 and IL-10 of normal group was significantly different from the study group and the control group (P< 0.001), and the study group and the control group's were significantly lower than the normal group.②With the increase of treatment time, serum IL-10, TGF-β1 levels of patients in the study group increased gradually. Four point method ocular symptoms score, VAS ocular symptoms score and total score of RQLQ decreased gradually; ③patients in the control group after 2 weeks'treatment, serum IL-10, TGF-β1 was higher than that before treatment (P< 0.001), at the same time all symptom scores, total score of RQLQ were lower than those before treatment (P< 0.001). ④After 2 weeks' treatment, patients in the study group, the serum IL-10 is higher than that of control group (P< 0.001); ⑤Before treatment serum IL-10, TGF-β1 of AR patients might have little correlation with symptom scores, total score of RQLQ on linear (P> 0.05).Conclusion:①serum IL-10, TGF-β1 levels of AR patients may be lower thannormal, and IL-10, TGF-β1 may be involved in the pathogenesis of AR. ②Changlekang may increase the production of serum IL-10, TGF-β1 in AR patients. ③AR patients with desloratadine citrate and mometasone furoate nasal spray treatment combined with Canglekang may promote higher serum IL-10 production than conventional two combination therapy, but there is no more significant improvement in symptoms score and quality of life score. ④Changlekang may improve ocular symptoms and the quality of life in AR patients. ⑤Before treatment serum IL-10, TGF-β1 of AR patients may have little correlation with symptom scores, total score of RQLQ, as a result the level of serum IL-10 and TGF-β1 can not be used to evaluate the severity of AR for the time being.

Effect of topical 3% diquafosol sodium on eyes with dry eye disease and meibomian gland dysfunction.

PurposeTo prospectively evaluate the effect of topical diquafosol sodium on eyes with dry eye disease (DED) and meibomian gland dysfunction (MGD).Patients and methodsThe subjects were consecutive patients diagnosed with both DED and MGD at Inouye Eye Hospital between March and September of 2016. The subjects were administered topical 3% diquafosol sodium ophthalmic solution six times a day for 3 months. At each study visit, subjects underwent slit-lamp examination and completed MGD symptoms and dry eye-related quality of life score (DEQS) questionnaires. Meibum quality (meibum score) and meibomian gland loss (meiboscore) were evaluated. Tear lipid layer thickness was measured in both eyes with an ocular surface interferometer immediately after clinic arrival and 20 minutes after instillation of one drop of topical diquafosol.ResultsThirteen patients (3 men, 10 women) with a mean age of 69.5±8.3 years completed the 3-month study. The number of telangiectasia and plugged meibomian gland orifices significantly decreased from baseline after 1 month of diquafosol use. The meibum score and the meiboscore significantly decreased from baseline at 3 months. Also, the lipid layer thickness was greater after diquafosol administration than before administration at baseline and 1, 2, and 3 months by 12.2, 11.5, 9.5, and 17.0 nm, respectively, but this difference was only significant at 3 months (p=0.039). The DEQS ocular symptom (p=0.065) and MGD questionnaire (p=0.081) scores tended to be lower than baseline at 3 months.ConclusionDiquafosol sodium ophthalmic solution improves DED- and MGD-related signs in eyes with MGD.

A Possible Association Between Dry Eye Symptoms and Body Fat: A Prospective, Cross-Sectional Preliminary Study.

To examine the relationship between dry eye symptoms and adiposity in a population study. A prospective cross-sectional single-visit preliminary study was designed to sample ocular symptoms and indices of adiposity in the general adult population. Patients recruited from the UNSW optometry clinic, the university campus and surrounding community, and overseas were invited to complete a survey composed of the short form Dry Eye Questionnaire (SFDEQ) (Dry Eye Questionnaire-5 or Contact Lens Dry Eye Questionnaire-8) and the Ocular Comfort Index (OCI) via hardcopy or online. Participants self-measured their weight, height, waist circumference (WC), and body fat % (optional). Associations between measures of adiposity (Body mass index [BMI], WC, and body fat %) and ocular symptoms scores (SFDEQ and OCI) were determined using Spearman correlation coefficients. Group differences were compared using independent t test. Three hundred and five participants including 52 contact lens wearers completed the study and 78 of them measured body fat %. There was a moderate correlation between body fat % and dry eye symptoms (SFDEQ r=0.34, P=0.003; OCI r=0.32, P=0.004). The interaction between body fat % and gender, wear of contact lenses, and older age were shown to be significant predictors of less ocular comfort in multivariate analysis (F(3,74)=12.13, P<0.001). An association between adiposity measured by body fat % and symptoms of dry eye was demonstrated in the general adult population. Confirmation of these findings in a large study is required.

Morphology and Function of Meibomian Glands and Other Tear Film Parameters in Junior High School Students.

Purpose:We measured tear film parameters, including the morphology and function of meibomian glands, in junior high school students at 15 years of age.Methods:A total of 111 eyes of 111 students (56 males and 55 females) were enrolled in the study. The ocular symptom score (0–14), after-school study time, lipid layer thickness (LLT) of the tear film, partial blink rate, lid margin abnormalities (0–4), tear film breakup time, corneal and conjunctival epithelial damage (fluorescein staining score, 0–9), meiboscore as determined by noncontact meibography (0–6), Schirmer test value, and meibum grade (0–3) were determined. The relationships between parameters were evaluated with the Spearman correlation coefficient (ρ).Results:The meiboscore was 2.8 ± 1.2, and the meibum grade was 1.8 ± 1.2. The meiboscore significantly correlated with the meibum grade (ρ = 0.272, P = 0.004), Schirmer test value (ρ = −0.220, P = 0.021), and LLT (ρ = −0.264, P = 0.005). The breakup time significantly correlated with LLT (ρ = 0.261, P = 0.006), meibum grade (ρ = −0.338, P < 0.001), and fluorescein staining score (ρ = −0.214, P = 0.025). The partial blink rate significantly correlated with the Schirmer test value (ρ = −0.240, P = 0.011). The meiboscore (P < 0.001) and meibum grade (P = 0.032) were significantly greater in males than in females.Conclusions:The morphology and function of meibomian glands are altered even at 15 years of age, with the changes being more prominent in males than in females.

Evaluation of meibomian gland and tear film changes in patients with pterygium.

Background:Recent studies have demonstrated that pterygium has a close relationship with dry eye disease. This study is to determine abnormalities in meibomian gland and tear function in patients with pterygium and to assess the relationship between the variables.Materials and Methods:Forty eyes from forty patients with primary nasal pterygium and forty eyes from forty volunteers without ocular pathologies were enrolled in this study. Ocular surface disease index scores, meibomian gland expression scores, lid margin abnormality scores, meiboscore, tear film breakup time (BUT), Schirmer test (SIT) value, and the lower tear meniscus height (TMH), tear meniscus depth (TMD), and tear meniscus area (TMA) using Fourier domain optical coherence were performed. Analysis of variance was applied for intergroup comparisons. A statistical significance level of P < 0.05 was considered.Results:Ocular symptom scores, BUT scores, lid margin abnormality, meibomian gland expression, and meiboscore were significantly higher in pterygium patients than in controls (P < 0.01 for all scores). However, the SIT scores, the lower TMH, TMD, and TMA values did not revealed a significant difference between two groups (all P > 0.05). Multivariate regression analysis demonstrated that meiboscore significantly correlated with ocular symptom scores, BUT, lid margin abnormality scores, and meibomian gland expression scores.Conclusions:Meibomian gland function may be altered in pterygium patients, which is associated with uncomfortable ocular symptoms. Being aware of meibomian gland changes seems essential to understand the complex relationship among pterygium, tear film functions, and ocular surface changes.

A New Class of Polymeric Anti-Allergen Nasal Barrier Film Solution for the Treatment of Allergic Rhinitis

Objective: Allergic rhinitis (AR) is oversensitivity of nasal mucosa to allergen exposure leading to IgE-mediated nasal mucosal inflammation and cellular destruction. Applying any chemical drug over the nasal mucosa may provide symptomatic relief but at the same time the presence of chemicals, such as cortisones and antihistaminic, hampers mucosa repair and, in consequence, cellular defense functions. Therefore, cleaning, avoiding allergen exposure, and protecting nasal mucosa from contact with allergens with a cell-friendly mechanical device, could be an effective remedy to treat allergic rhinitis. Methods: A double blind, randomized, placebo controlled, multicenter clinical trial was conducted in patients suffering from severe AR. 15 patients were treated with saline as comparator product (CP) versus 31 treated with the test product (TP). The test product contained a natural gum-glycerol solution (VB-Gy) which was rendered filmogen using inert natural polymers (Allercyanidin-H) and termed as VB-Gy-Allercyanidin-H formula. The products (15 ml sprays) were applied topically over the nasal mucosa, 3-4 times a day over a period of 3 weeks. Total, reflective and instantaneous nasal symptom scores for rhinorrhea, nasal discharge, sneezing, and itching, as well as ocular scores (itching, tearing, redness) and rescue medicine use scores were evaluated daily during weeks -1 to +3 employing a 0 (no symptoms) to 3 (severe symptoms) scoring scale. Rhino-conjunctivitis quality of life (RQLQ) questionnaires were completed at the start and at the end of the study. Saline solution (CP) was used identically to the TP. Mean weekly results in CP and TP groups were compared with the scores at the start of treatment (baseline) and between the two groups. Results: CP was found to reduce only slightly the symptomatic manifestation of allergic rhinitis. The mean reduction compared to baseline at the end of weeks 1, 2, and 3 was respectively 11.7%, 13.6% and 15.1% for total nasal symptom scores (rTNSS); 9.9%, 14.5%, and 15.8% for total ocular symptom scores (rTOSS); and 4.97%, 8.45%, and 10.94% for pre-dose instantaneous total ocular symptom scores (am-iTOSS, p: Not Significant: NS). During the same period, compared to CP scores, the reduction in TP group was higher by 37.7%, 58.4%, and 73.5% for rTNSS; 38.3%, 54.6%, and 64.1% for rTOSS and 29.84%, 48.91%, and 59.77% for am-iTOSS (p<0.05 for all parameters vs. CP at the same time points). The rhinoconjunctivitis quality of life questionnaire (RQLQ), measured using standard established questionnaire, was improved by 50.28% in TP group compared to 22.85% in CP group. During the study period, at least one rescue medicine was used by 80% patients in CP group compared to only 29% in TP group. Both products were well tolerated and induced no undesired effects. Conclusion: In the absence of any cell-friendly, safe, and multi-target treatment for allergic rhinitis, using a mechanically acting, filmogen barrier solution capable of blocking new allergen contact and minimizing the concentration of immune cells on the nasal surface represents a simple but highly effective approach for the treatment of common allergic rhinitis.

Redness response phenotypes of allergic conjunctivitis in an allergen challenge chamber

BackgroundThere are few direct data concerning symptom dynamics of allergic conjunctivitis (AC) in an allergen challenge chamber (ACC). ObjectiveTo determine the AC dynamics on subsequent exposures to ragweed pollen (RW) in individuals with allergic rhinitis in an ACC. To determine whether consecutive exposures in an ACC have any persistent detrimental ocular physical effects. MethodsParticipants underwent 3 exposures to RW in an ACC. Ocular symptoms of itching and tearing were self-assessed. Ocular redness and lid swelling were assessed by trained ophthalmic technicians. Complete ophthalmic examinations (COEs) were performed by an ophthalmologist. ResultsA total of 188 of 201 participants (93%) developed an ocular redness score of 2 or more in each eye in ACC exposure 1. Reproducibility of redness occurred in approximately 70% of individuals completing ACC exposures 1 through 3. There were no significant changes between baseline COE and end of study COE. Phenotypes were identified by redness responses during and after exposure. Baseline total ocular symptom scores, at 24 hours after a priming exposure, were identified as late-phase reactions rather than enhanced sensitivity. ConclusionWhen assessed by trained professionals, AC was present with a very high frequency in selected individuals allergic to RW monitored in an ACC. Intrasubject reproducibility of redness was consistent across 3 ACC allergen exposures. Phenotypes were identified as early-phase responses, protracted early-phase responses, dual responses, and late-phase responses. Trial Registrationclinicaltrials.gov Identifier: NCT02079649.

Therapeutic comparability of Dezrinit and Nazonex® in control of symptoms of allergic rhinitis. The results of a multicenter, open, randomized, comparative study in parallel groups

Background. To study efficacy and safety of Dezrinit (mometasone furoate, metered dose nasal spray, 200 pg/day) in comparison with Nasonex® (mometasone furoate, metered dose nasal spray, 200 pg/day) upon administration for 14 days in adult patients with seasonal allergic rhinitis. Materials and methods. A total of 141 patients were enrolled into the study at 8 study centers in the RF, of which 134 patients were randomized: 67 patients into the experimental group (Dezrinit) and 67 patients into the comparison group (Nasonex®). patients were randomized to receive treatment either with Dezrinit or Nasonex®. Efficacy was assessed based on reflective Total Nasal Symptom Score (rTNSS) and instantaneous Total Nasal Symptom Score (iTNSS); reflective Total Ocular Symptom Score (rTOSS) and instantaneous Total Ocular Symptom Score (iTOSS). Overall proportion of patients who responded to treatment was evaluated according to overall assessment of treatment efficacy both by a patient and by an investigator. AEs were reported for safety assessment. Results. After 14 days of treatment a marked improvement of symptoms was observed in both groups based on all assessed scores. Mean change (SD) in rTNSS from baseline was -11,91 (4,625) scores and -11,64 (4,58) scores in the experimental and comparison groups, respectively (within group differences, p

Long-term effects of a house dust mite sublingual immunotherapy tablet in an environmental exposure chamber trial

BackgroundTreatment with SQ house dust mite (HDM) sublingual immunotherapy (SLIT) tablet is effective for HDM respiratory allergic disease, but data on long-term effects are lacking. ObjectivePost hoc analyses were conducted to determine the long-term effect of SQ HDM SLIT-tablet on nasal, ocular, and cough symptoms 1 year after discontinuation of treatment. MethodsStudy participants underwent environmental exposure chamber (EEC) challenges at baseline and week 24 in a randomized, placebo-controlled, double-blind trial (NCT01644617) during which participants received daily 12 SQ-HDM, 6 SQ-HDM, or placebo for 24 weeks. Asthma had to be stable, well controlled, and nonsevere. The mean total asthma symptom score (TASS; sum of 3 symptoms: cough, wheeze, and dyspnea) during baseline and week 24 EEC challenge was analyzed in all participants who completed the trial (n = 106). Approximately 1 year after trial completion, another EEC challenge was conducted in a subset of participants (n = 51). Total nasal symptom score (sum of 4 symptoms), total ocular symptom score (sum of 2 symptoms), and cough were assessed. ResultsCompared with baseline and end-of-treatment values, sustained improvement of all symptoms assessed at the 1-year follow-up EEC challenge was evident in participants treated with 12 SQ-HDM. Results with 6 SQ-HDM were less notable. After 24 weeks of 12 SQ-HDM, TASS during EEC challenge was improved 65% vs baseline; at 1-year follow-up, cough was improved 57% vs baseline. ConclusionPersistent improvement of nasal and ocular symptoms was observed up to 1 year after completing 24 weeks of 12 SQ-HDM treatment. Beneficial effects on cough were also observed. Trial Registrationclinicaltrials.gov Identifier NCT01644617.

Vision-related quality of life and psychological status in Chinese women with Sjogren's syndrome dry eye: a case-control study.

BackgroundSjogren’s syndrome dry eye (SSDE) mainly affects middle-aged women and can negatively affect women’s psychological and social functioning. However, little is known about the correlation between vision-related quality of life (VR-QoL) and psychological status for women with SSDE. We therefore examined VR-QoL and psychological status in two groups of Chinese women: an SSDE group and a non-SSDE group. We also explored the associations between VR-QoL scores, sociodemographic measures, ophthalmologic parameters, and psychological status in women with SSDE.MethodsThe case-control study recruited 30 female outpatients with SSDE and 30 without SSDE from the Eye and Ear, Nose, and Throat (ENT) Hospital of Fudan University. Demographic and ophthalmologic data were collected from all participants. Ophthalmologic examinations included best-corrected visual acuity (BCVA), corneal fluorescein staining (CFS), tear break-up time (TBUT) and Schirmer test. Data collected using the National Eye Institute’s Visual Function Questionnaire (NEI-VFQ) and Ocular Surface Disease Index (OSDI) survey instruments were analyzed to identify potential differences in VR-QoL between the SSDE group and the non-SSDE group. We also used the Zung Self-Rating Anxiety and Self-Rating Depression Scales (SAS and SDS) to determine psychological status in both groups.ResultsThe SSDE group scored significantly lower than the non-SSDE group on the NEI-VFQ subscales of general health, general vision, and long-distance vision activities (all p < 0.05). The SSDE group achieved a significantly higher ocular symptoms score compared with the control group (p = 0.0256). The SAS and SDS scores of the SSDE group were significantly higher than the non-SSDE group (p = 0.0072 and 0.0162, respectively). The prevalence of anxiety and depression in the SSDE group was significantly higher than the non-SSDE group (p = 0.0240 and 0.0200, respectively). Nine of twelve NEI-VFQ subscales were negatively correlated with SAS/SDS scores (all p values were <0.05). The exceptions were social function, color vision and peripheral vision. The composite OSDI score and its three subscale scores for the women in the SSDE group were all positively correlated with overall SAS/SDS scores (all p values were <0.05).ConclusionsBoth VR-QoL and psychological status were significantly worse in SSDE group than in the non-SSDE group. The VR-QoL of women with SSDE had a negative correlation with their anxiety and depression levels.

Observation of Influence of Cataract Surgery on the Ocular Surface

IntroductionTo evaluate meibomian gland function, changes of lacrimal tears and ocular surface parameters and tear inflammatory mediators following cataract surgery.Methods48 eyes of 34 patients who underwent uncomplicated phacoemulsification were involved and divided into 2 groups with those who had preexisting dry-eye before cataract surgery and those who did not. Ocular symptom score, Schirmer I test, tear film break-up time (TBUT), corneal sensitivity threshold, corneal staining, inflammatory cytokine activities, lid margin abnormalities, meibum expressibility, meibum quality and meibomian gland imaging were evaluated preoperatively, at 1 day, 1 and 2 months postoperatively.ResultsOcular symptom scores were worse at 1 and 2 months postoperatively but, TBUT, corneal staining score and corneal sensitivity threshold showed gradual improvements at 1 month and 2 months postoperatively (p<0.05, respectively). Interestingly there were statistically significant improvements in TBUT, corneal staining score and corneal sensitivity threshold at 1 month postoperatively when topical eye drops were used compared to the period without topical therapy which is the months 2 postoperatively. There were statistically significant decreases in IL-1β, IL-6, IL-8, MCP-1, TNF-α and IFN-γ concentrations at 1 and 2 months postoperatively. Lid margin abnormalities, meibum quality and expressibility scores increased significantly (p < 0.05, respectively) at postoperative period. Compared with the no dry eye group, dry eye group revealed significantly higher ocular symptom scores, lower TBUT, higher lid margin abnormalities, meibum quality and expressibility scores after cataract surgery. There were significant correlations between IL-6 and parameters of dry eye, and between MGD parameters and ocular symptom scores.ConclusionsOur study revealed that meibomian gland function is influenced after cataract surgery accompanying structural changes and these were correlated with increased ocular symptom scores. Therefore, it could elucidate the development of dry eye related to cataract surgery.

Do Probiotics have a role in the Treatment of Allergic Rhinitis? A Comprehensive Systematic Review and Metaanalysis

To investigate clinical evidence for the efficacy of probiotics in the treatment of allergic rhinitis (AR). A systematic search was conducted to review the results of all randomized, double-blind, placebo-controlled trials by following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Statement. Primary outcome measurements were total nasal and ocular symptom scores (SS) and quality of life (QoL) questionnaires. Secondary outcome measurements were individual nasal SS and immunologic parameters. Twenty-two randomized, double-blind, placebo-controlled studies were included. Seventeen trials showed significant benefit of probiotics clinically, whereas eight trials showed significant improvement in immunologic parameters compared with placebo. All five studies with Lactobacillus paracasei (LP) strains demonstrated clinically significant improvements compared with placebo. Probiotics showed significant reduction in nasal and ocular SS (standardized mean difference [SMD], -1.23, p < 0.001; and SMD, -1.84, p < 0.001; respectively), total, nasal, and ocular QoL scores compared with placebo (SMD, -1.84, p < 0.001; SMD, -2.30, p = 0.006; and SMD, -3.11, p = 0.005; respectively). Although heterogeneity was high, in subgroup analysis, SMD for total nasal and ocular symptoms with patients with seasonal AR and for nasal QoL scores for studies with LP-33 strain were significant and homogenous. Scores of nasal blockage, rhinorrhea, and nasal itching were significantly lower in the probiotic group compared with placebo. The meta-analysis studies SS the Japanese guidelines revealed a significant, homogenous SMD score of -0.34 for individual nasal SS, above the minimal important clinical difference value of 0.3. The T-helper 1 to T-helper 2 ratio was significantly lower in the probiotic group compared with placebo (SMD, -0.78; p = 0.045). Despite high variability among the studies, synthesis of available data provided significant evidence of beneficial clinical and immunologic effects of probiotics in the treatment of AR, especially with seasonal AR and LP-33 strains. With the rising pool of studies, the most promising strains in specific allergies can be revealed and adjuvant therapy with probiotics can be recommended for the treatment of AR.

Long-term safety and efficacy of bilastine following up to 12 weeks or 52 weeks of treatment in Japanese patients with allergic rhinitis: Results of an open-label trial

Bilastine is a novel second-generation antihistamine. This open-label, single-arm, phase III study evaluated the safety and efficacy of long-term treatment with bilastine in Japanese patients with seasonal (SAR) or perennial allergic rhinitis (PAR). Patients with SAR or PAR who met the registration criteria and did not violate the exclusion criteria received bilastine (20mg, once daily) for 12 weeks (treatment period). Patients with PAR who met the transition criteria could elect to continue the bilastine treatment for an additional 40 weeks (continuous treatment period: a total of 52 weeks). Safety and tolerability were the primary outcomes, and the main secondary endpoint was to evaluate changes in efficacy variables from baseline measurements. Fifty-eight patients with SAR and 64 patients with PAR received bilastine (20mg/day) for 12 weeks. Fifty-five patients with PAR transitioned to the continuous treatment period. Adverse events (AEs) were reported by 17.2% of patients with SAR and by 31.3% of patients with PAR, and adverse drug reactions (ADRs) were reported by 6.3% of patients with PAR but by no patients with SAR during the 12-week treatment period. All of the ADRs were mild in severity. During the 52-week treatment period, AEs and ADRs were reported by 73.4% and 6.3% of patients with PAR, respectively. All of the ADRs occurred during the 12-week treatment period, and none during the continuous treatment period. The AEs were categorized using the System Organ Class of nervous system disorders; 4.7% of patients reported headache, but none reported somnolence. One serious AE was reported, but it was considered to be unrelated to the bilastine treatment. There were no deaths, and no patients withdrew from the study because of AEs. In patients with SAR, bilastine significantly decreased the total nasal symptom score (TNSS), total ocular symptom score (TOSS), and total symptom score (TSS) relative to baseline. Prolonged treatment with bilastine resulted in the maintenance of a significant reduction in TNSS, TOSS, and TSS from the baseline in patients with PAR. Improvement of quality of life was also observed in patients with SAR and PAR. Bilastine was safe, well tolerated, and effective for patients with SAR and PAR. The observed improvement was maintained for the duration of the study, with no loss of drug efficacy (registration number JapicCTI-142622).

Mechanisms, safety and efficacy of a B cell epitope-based vaccine for immunotherapy of grass pollen allergy

BackgroundWe have developed a recombinant B cell epitope-based vaccine (BM32) for allergen-specific immunotherapy (AIT) of grass pollen allergy. The vaccine contains recombinant fusion proteins consisting of allergen-derived peptides and the hepatitis B surface protein domain preS as immunological carrier. MethodsWe conducted a randomized, double-blind, placebo-controlled AIT study to determine safety, clinical efficacy and immunological mechanism of three subcutaneous injections of three BM32 doses adsorbed to aluminum hydroxide versus aluminum hydroxide (placebo) applied monthly to grass pollen allergic patients (n=70). Primary efficacy endpoint was the difference in total nasal symptom score (TNSS) through grass pollen chamber exposure before treatment and 4weeks after the last injection. Secondary clinical endpoints were total ocular symptom score (TOSS) and allergen-specific skin response evaluated by titrated skin prick testing (SPT) at the same time points. Treatment-related side effects were evaluated as safety endpoints. Changes in allergen-specific antibody, cellular and cytokine responses were measured in patients before and after treatment. ResultsSixty-eight patients completed the trial. TNSS significantly decreased with mean changes of −1.41 (BM32/20μg) (P=0.03) and −1.34 (BM32/40μg) (P=0.003) whereas mean changes in the BM32/10μg and placebo group were not significant. TOSS and SPT reactions showed a dose-dependent decrease. No systemic immediate type side effects were observed. Only few grade 1 systemic late phase reactions occurred in BM32 treated patients. The number of local injection site reactions was similar in actively and placebo-treated patients. BM32 induced highly significant allergen-specific IgG responses (P<0.0001) but no allergen-specific IgE. Allergen-induced basophil activation was reduced in BM32 treated patients and addition of therapy-induced IgG significantly suppressed T cell activation (P=0.0063). ConclusionThe B cell epitope-based recombinant grass pollen allergy vaccine BM32 is well tolerated and few doses are sufficient to suppress immediate allergic reactions as well as allergen-specific T cell responses via a selective induction of allergen-specific IgG antibodies. (ClinicalTrials.gov number, NCT01445002.)

Efficacy of MP-AzeFlu in children with seasonal allergic rhinitis: Importance of paediatric symptom assessment.

This study aimed to assess the efficacy of MP-AzeFlu (a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate in a single spray) in children with seasonal allergic rhinitis (SAR) and explore the importance of child symptom severity assessment in paediatric allergic rhinitis (AR) trials. A total of 348 children (4-11 years) with moderate/severe SAR were randomized into a double-blind, placebo-controlled, 14-day, parallel-group trial. Efficacy was assessed by changes from baseline in reflective total nasal symptom score (rTNSS), reflective total ocular symptom score (rTOSS) and individual symptom scores over 14 days (children 6-11 years; n = 304), recorded by either children or caregivers. To determine whether a by-proxy effect existed, efficacy outcomes were assessed according to degree of child/caregiver rating. Moreover, total Paediatric Rhinitis Quality of Life Questionnaire (PRQLQ) score was compared between the groups. A statistically superior, clinically relevant efficacy signal of MP-AzeFlu versus placebo was apparent for PRQLQ overall score (diff: -0.29, 95% CI -0.55, -0.03; p = 0.027), but not for rTNSS (diff: -0.80; 95% CI: -1.75; 0.15; p = 0.099). However, as the extent of children's self-rating increased, so too did the treatment difference between MP-AzeFlu and placebo; MP-AzeFlu provided significantly better relief than placebo for rTNSS (p = 0.002), rTOSS (p = 0.009) and each individual nasal and ocular symptom assessed (except rhinorrhoea; p = 0.064) when children mostly rated their own symptoms. MP-AzeFlu is an effective treatment for AR in childhood. Caregivers are less able than children to accurately assess response to treatment with available tools. A simple paediatric-specific tool to assess efficacy in AR trials in children is needed.

Ethnicity influences disease characteristics and symptom severity in allergic rhinitis patients in Malaysia.

The number of available reports regarding the influence of ethnicity on clinical features of allergic rhinitis (AR), especially disease severity in tropical climates, is limited. We aimed to compare clinical parameters and disease severity in AR patients of different ethnicities. Malay, Chinese, and Indian AR patients (n = 138) with confirmed sensitivity to Dermatophagoides pteronyssinus, Dematophagoides farinae, and Blomia tropicalis were tested for mite-specific immunoglobulin E (sIgE) levels. A detailed questionnaire was used to collect data on nasal symptom score (NSS), ocular symptom score (OSS), sum of symptoms score (SSS), quality of life score (QLS), symptomatic control score (SCS), and total sum of scores (TSS) and correlate the derived data with patients' demography, mite-polysensitivity, and sIgE levels. AR-related symptoms were most severe in Malays and least in Chinese (p < 0.01). Age (r = 0.516 to 0.673, p < 0.05) and duration of AR (r = 0.635 to 0.726, p < 0.01) correlated positively with severity domains (NSS, SSS, QLS, and TSS) in Chinese. Duration of concurrent allergies was highest in Malays (p < 0.05). Polysensitivity predicted increased sIgE levels in Malays (r = 0.464 to 0.551, p < 0.01) and Indians (r = 0.541 to 0.645, p < 0.05) but affected NSS, SSS, and TSS only in Indians (r = 0.216 to 0.376, p < 0.05). sIgE levels were lowest among Chinese but correlated strongly with NSS, OSS, SSS, and TSS (r = 0408 to 0.898, p < 0.05). Clinical parameters in AR may be influenced by race. Symptoms were most severe among Malays but did not correlate with other variables examined. Although Indian ethnicity did not impact disease severity, duration of concurrent allergies and mite-polysensitivity was associated with more severe disease. Age, duration of disease, and sIgE levels may be useful indicators of disease severity in Chinese.