Schirmer Test Scores Research Articles

The Impact of Bilateral Subepithelial Corneal Infiltrates on Tear Film After Epidemic Keratoconjunctivitis.

To evaluate the effect of corneal subepithelial infiltrates (SEIs) on tear film function and best-corrected visual acuity (BCVA) after persistent epidemic keratoconjunctivitis (EKC) and to compare the findings with controls. In this prospective, cross-sectional study, 38 patients with EKC and 42 healthy volunteers were enrolled. While patients with SEIs after EKC made up groups 1a (first involved eye) and 1b (second involved eye), healthy controls made up group 2. Best-corrected visual acuity, corneal subepithelial infiltrate scoring (CSIS), Fantes score, tear breakup time (TBUT), Schirmer test, and ocular surface disease index (OSDI) scores were measured. The Oxford grading system was used to score corneal staining. The mean Fantes score was 1.8±0.8 for group 1a and 1.3±1.1 for group 1b (P=0.03). The mean CSIS was 2.9±1.3 for group 1a and 1.9±1.7 for group 1b (P=0.005). But there was no significant difference in terms of the mean BCVA, TBUT, Schirmer, OSDI, and Oxford grading (P=0.66, 0.9, 0.9, 0.9, and 1.0, respectively) between group 1a and group 1b. The mean BCVA, TBUT, Schirmer, and OSDI values were worse in group 1a and group 1b in comparison to group 2 (P=0.001). We showed that the first involved eyes of patients with SEIs may be affected more significantly, but this difference may not have a clinical reflection on the difference in tear film functions between two eyes. However, compared with the healthy eyes, tear film function and BCVA were equally compromised in both eyes of the patients with SEIs irrelevant to the involved eye.

Dry eye syndrome in benign essential blepharospasm

To determine the significance of dry eye syndrome in benign essential blepharospasm. Retrospective consecutive case series. One hundred and forty-four patients (288 eyes) with benign essential blepharospasm. All subjects had Schirmer I tear tests. Those scores were analysed as a function of patient age, sex, and blepharospasm severity. Individual Schirmer-test scores in both eyes of all patients. A total of 144 eligible subjects (mean age±SD: 68.3±11.5 years; 76% females) were evaluated. Benign essential blepharospasm was significantly associated with female sex (P=0.0044). The mean Schirmer-test value was 5.9±7.5 (median: 2.5) mm; it was <15mm for 86.8% of the patients and <10mm for 75%, with no difference observed between men and women (P=0.27). Dry-eye syndrome severity was not correlated with age at diagnosis, for men (r=-0.22, P=0.22) or women (r=-0.067, P=0.49), or benign essential blepharospasm severity (P=0.15), but was strongly associated with benign essential blepharospasm independently of age, sex or blepharospasm intensity. Dry-eye syndrome and benign essential blepharospasm are strongly linked, independently of age, sex or BEB severity, and should be considered for the diagnosis of benign essential blepharospasm. The useful symptomatic treatment of dry eye will not cure the blepharospasm or the ocular pain, and specific treatment for blepharospasm is required, i.e., quarterly injections of botulinum toxin A into the orbicularis oculi muscle.

Topical cyclosporine A therapy for dry eye syndrome.

Topical cyclosporine A therapy for dry eye syndrome.

Efficacy of cyclosporine 0.05% in patients with dry eye syndrome

Background: An even and smooth ocular surface is vital for the functioning and comfort of the eyes. Dry eye is a group of disorders of the tear film which is due to either decreased production or increased evaporation and is associated with symptoms of ocular discomfort. Smoking and drugs have been suggested as risk factors in various studies. Cyclosporine has been shown to reduce the cell-mediated inflammatory reactions associated with the inflammatory ocular surface disease.Methods: 50 eyes of 25 patients suffering from dry-eye syndrome were included in this study. Three major ocular symptoms of dry eye i.e., ocular pain, burning, and foreign body sensation were studied in this study. Each symptom was given a score from 0 to 1 so that the ocular symptoms were given a score from 0 to 3.Results: There was a significant reduction in ocular symptoms score (OSS) 2.25 before treatment to 0.6 after 3 months of treatment (p=0.01). In addition, the Schirmer's paper test scores improved from 1.23 mm to 5.91 mm, which is significantly different (p=0.001). The tear film breakup time also improved from 5.49s to 9.86s.Conclusions: Cyclosporine 0.05% has been established to be effective and safe in our study.

Intense pulsed light therapy: A promising complementary treatment for dry eye disease

Abstract Objective To propose the intense pulsed light (IPL) therapy as a helpful supplementary treatment in patients with dry eye disease. Material and methods Retrospective cross sectional design. Medical records of patients in whom dry eye disease symptoms were not satisfactorily controlled with medical therapy alone and who underwent additional IPL therapy, and tree sessions were completed. Data were analyzed before therapy and 3 weeks after its completion to assess improvement. Determination of symptoms, through a visual analog scale; tear film stability, through tear Break Up Time (tBUT); measurement of tear secretion, through Schirmer Test; and ocular surface staining with Van Bijsterveld score were evaluated. SPSS software and nonparametric analysis of repeated measures were used. The study was approved by the ethics committee. Results 50 eyes from 25 subjects were reviewed. There were 9 males (36%) and 16 females (64%), with a median age of 59 years (IQR 52–64). The median of the symptoms scale was 8 (IQR 8–9) and 3 (IQR 2–4) before and after the therapy respectively (p Conclusion IPL treatment has excellent results regarding both: dry eye disease symptoms improvement and in office objective tests such as tBUT, Schirmer test and Van Bijsterveld score; IPL could be considered as an effective adjunct for dry eye disease.

RETRACTED ARTICLE: Comparison of 0.05% cyclosporine and 3% diquafosol solution for dry eye patients: a randomized, blinded, multicenter clinical trial

BackgroundThis study is aim to compare the clinical effectiveness between the two most prominent dry eye disease (DED)-specific eye drops, 0.05% cyclosporine (CN) and 3% diquafosol (DQ).MethodsThis is a multi-centered, randomized, masked, prospective clinical study. A total of 153 DED patients were randomly allocated to use CN twice per day or DQ six times daily. Cornea and conjunctival staining scores (NEI scale), tear break-up time (TBUT), Schirmer test scores, and ocular surface disease index (OSDI) score were measured at baseline, 4 and 12 weeks after treatment.ResultsAt 12 weeks after treatment, NEI scaled scores were significantly reduced from the baseline by − 6.60 for CN and − 6.63 for DQ group (all P < 0.0001, P = 0.9739 between groups). TBUT and Schirmer values for CN were significantly improved from the baseline at 4 and 12 weeks (P = 0.0034, P < 0.0001 for TBUT, P = 0.0418, P = 0.0031 for Schirmer test). However, for DQ, TBUT showed significant improvement at 12 weeks only (P = 0.0281). Mean OSDI score differences from the baseline to 12 weeks were improved by − 13.03 ± 19.63 for CN and − 16.11 ± 20.87 for DQ, respectively (all P < 0.0001, P = 0.854 between groups). Regarding drug compliance, the mean instillation frequency of CN was less than that of DQ (P < 0.001). There were no statistically significant intergroup differences in safety evaluation.ConclusionsThe level of improvement regarding NEI, TBUT, and OSDI scores were not significantly different between the two treatment groups. However, with regards to the early improvement of TBUT and patient compliance, patients using CN improved faster and with greater adherence to drug usage than did those treated with DQ.Trial registrationKCT0002180, retrospectively registered on 23 December 2016.

The Improvement of Dry Eye Symptoms after Pinguecula Excision and Conjunctival Autograft with Fibrin Glue.

Purpose To evaluate the association between pinguecula excision and subsequent improvement in dry eye syndrome. Methods We included 30 consecutive patients with primary nasal pinguecula and dry eye symptoms undergoing ocular surgery for the first time. Criteria for pinguecula excision surgery were nasal location, yellowish color, and protrusion of conjunctiva at least 2 times thicker than adjacent normal conjunctiva as measured by anterior segment optical coherence tomography. Our primary outcomes were 3-month postoperative changes in tear film breakup time (TBUT), Schirmer test, and a dry eye symptom score. Results 30 eyes from 30 different patients (12 men and 18 women) underwent pinguecula excision and conjunctival autografting using fibrin glue. The mean age was 42.5 ± 8.35 (range 28–63) years. The preoperative protrusion ratio of pinguecula was 2.33 ± 0.28 (range 2.00–2.90). Mean preoperative TBUT, Schirmer test, and dry eye symptom scores were 5.10 ± 1.27 seconds, 6.07 ± 2.27 mm, and 2.80 ± 0.76 points. Mean postoperative 3-month TBUT, Schirmer test, and dry eye symptom scores were 7.80 ± 1.13 seconds, 7.27 ± 2.02 mm, and 0.30 ± 0.47 points, respectively. The median pre- and postoperative changes were found to be statistically significant by Wilcoxon signed-rank tests for TBUT, Schirmer test score, and dry eye symptom score. Conclusion Surgical excision of pinguecula and conjunctival autograft using fibrin glue is an effective and safe method to improve symptoms of dry eye syndrome.

Impact of Dry Eye on Visual Acuity and Contrast Sensitivity: Dry Eye Assessment and Management Study.

Identification of the association of specific signs of dry eye disease with specific visual function deficits may allow for more targeted approaches to treatment. The purpose of this study was to explore the association of dry eye signs and symptoms with visual acuity (VA) and contrast sensitivity in the Dry Eye Assessment and Management study. Baseline data from participants in the Dry Eye Assessment and Management study were used in this secondary cross-sectional analysis. Standardized procedures were used to obtain results on the Ocular Surface Disease Index (OSDI), high-contrast logMAR VA, contrast sensitivity, tear film debris, tear breakup time (TBUT), corneal fluorescein staining, meibomian gland evaluation, conjunctival lissamine green staining, and Schirmer test scores. Generalized linear models that included age, refractive error status, and cataract status were used to assess the association between VA and contrast sensitivity with OSDI score and each dry eye sign. The Hochberg procedure was used to account for multiple comparisons. Among 487 participants (974 eyes), worse VA was associated with worse mean score on the OSDI vision subscale (39.4 for VA 20/32 or worse vs. 32.4 for VA 20/16 or better; adjusted linear trend, P = .02); scores were not associated with contrast sensitivity. Severe meibomian gland plugging and abnormal secretions were associated with worse mean log contrast sensitivity (1.48 for severe vs. 1.54 for not plugged [P = .04] and 1.49 for obstructed vs. 1.57 for clear [P = .002], respectively). Longer TBUT was associated with better mean log contrast sensitivity (1.57 for TBUT >5 seconds and 1.51 for TBUT ≤2 seconds, P < .0001). Worse VA rather than worse contrast sensitivity drives vision-related symptoms in dry eye. Greater tear film instability was associated with worse contrast sensitivity.

Terapia de luz pulsada intensa regulada: un tratamiento complementario prometedor para la enfermedad de ojo seco

ObjectiveTo propose the Intense Pulsed Light (IPL) therapy as a helpful supplementary treatment in patients with dry eye disease. Material and methodsRetrospective cross sectional design. Medical records of patients in whom dry eye disease symptoms were not satisfactorily controlled with medical therapy alone and who underwent additional IPL with at least three sessions completed. Data were analyzed before therapy and 3weeks after its completion to asses improvement. Determination of symptoms, through a visual analog scale; tear film stability, through tear Break Up Time (tBUT); measurement of tear secretion, through Schirmer Test; and ocular surface staining with Van Bijsterveld score were evaluated. SPSS software and nonparametric analysis of repeated measures were used. The study was approved by the ethics committee. Results50 eyes from 25 subjects were reviewed. There were 9 males (36%) and 16 females (64%), with a median age of 59years (IQR 52-64). The median of the symptoms scale was 8 (IQR 8-9) and 3 (IQR 2-4) before and after the therapy respectively (P<.05). The median of BUT was 4 (IQR 3-5) and 10 (IQR 8-11), Schirmer test was 13 (IQR 12-15) and 15 (IQR 13-20), and Van Bijsterveld score was 3 (RIC 3-4) and 2 (IQR 2-3) before and after the therapy respectively (P<.05, for all measurements). ConclusionIPL treatment has excellent results regarding both: dry eye disease symptoms improvement and in office objective tests such as tBUT, Schirmer test and Van Bijsterveld score; IPL could be considered as an effective adjunct for dry eye disease.

Serum eye drops for the treatment of ocular surface diseases: a systematic review and meta-analysis.

The use of blood-derived eye drops for topical treatment of ocular surface diseases has progressively increased in recent years. To evaluate the use of serum eye drops in ocular surface disorders, we performed a systematic search of the literature. In this systematic review, we included 19 randomised controlled trials (RCTs) investigating the use of serum eye drops in 729 patients compared to controls. For the quantitative synthesis, we included only 10 RCTs conducted in patients with dry eye syndrome comparing autologous serum to artificial tears. At 2-6 weeks, no clear between-group differences in Schirmer test (MD 1.05; 95% CI: -0.17-2.26) and in fluorescein staining (MD -0.61; 95% CI: -1.50-0.28) were found (very low-quality evidence, down-graded for inconsistency, serious risk of biases, and serious imprecision). Slightly higher increase in tear film break-up time (TBUT) scores in autologous serum compared to control (MD 2.68; 95% CI: 1.33-4.03), and greater decrease in ocular surface disease index (OSDI) in autologous serum compared to control (MD -11.17; 95% CI: -16.58 - -5.77) were found (low quality evidence, down-graded for serious risk of bias, and for inconsistency). For the Schirmer test, fluorescein staining and TBUT, data were also available at additional follow-up timing (2-12 months): no clear between-group differences were found, and the quality of the evidence was graded as low/very-low. In patients with dry eye syndrome, it is unclear whether or not the use of autologous serum compared to artificial tears increases Schirmer test and fluorescein staining scores at short-term and medium-/long-term follow up. Some benefit at short-term follow up for the outcome of TBUT and OSDI was observed, but the quality of the evidence was low.

Digital Asthenopia: Portuguese Group of Ergophthalmology Survey.

Given the increasing use of electronic devices, and the increasing number of complaints with its use, we intend to evaluate the prevalence of manifestations of dry eye and ocular fatigue in a population of individuals, who use the computer daily to perform all their professional tasks, as well as to correlate these complaints with the number of hours of digital use as well as their possible improvement with behavioural measures and use of tear drops. A total of 77 individuals (154 eyes) were evaluated on two separate days with a 1-month interval. They completed two questionnaires: OSDI and PEG Eye Fatigue. An objective ocular surface assessment was performed: Schirmer test without anesthetic, DR-1a Dry Eye Monitor™, hyperemia evaluation, lacrimal break up, presence of keratitis and lesions in the conjunctiva, as well as near accommodation point and near convergence point. After the first evaluation, the subjects were divided into two groups: group A (< 2 hours of computer working) and group B (> 2 hours of computer working). Some environmental measures to reduce complaints and recommendation of use of artificial tears were explained to the latter. There was a statistically significant difference in the majority of the parameters evaluated in the group B, in relation to the morning period (group A) - tear film (p = 0.032), hyperemia (p < 0.001), BUT (p < 0.001), keratitis (p < 0.001), conjunctival lesion (p = 0.002) and accommodation point (p < 0.001). In the evaluation - one month later - there were no statistically significant differences in any of the parameters analysed in the group A, and in group B there was a decrease in most parameters at the end of that period - Schirmer test (p = 0.005), lacrimal film (p = 0.022), keratitis (p < 0.001), conjunctival lesion (p = 0.005) and fatigue score (p < 0.001). It was thus possible to show the appearance of ocular fatigue and ocular surface changes with prolonged use of computers (> 2 hours) as well as a significant improvement in symptomatology (subjective assessment) as well as of ocular surface changes (objective evaluation) with the implementation of postural measures, regular breaks and use of lubricants. This is the first study, to the best of our knowledge, of digital asthenopia in which, in addition to the subjective evaluation, the presence of ocular surface modifications (objective assessment) were evaluated and the respective improvement with the aforementioned ergophthalmological measures were evaluated. This survey highlights the increased overall level of awareness that we need to have to face the rapid and wide-scale changes driven by the emergence of digital technology and, more particularly, its impact on user's vision and posture. We concluded that the longer we use the electronic devices (more than two hours) the more severe the complaints and rates of ocular surface changes are. Environmental and ocular strategies can attenuate or even eliminate the discomfort caused by this syndrome, and increase professional performance and quality of life.

Effects of Polyunsaturated Fatty Acids on Nonspecific Typical Dry Eye Disease: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.

To investigate the effects of polyunsaturated fatty acids (PUFAs) in patients with dry eye disease (DED), a multifactorial inflammatory disorder, we searched Cochrane Library, EMBASE, PubMed, and Web of Science for randomized clinical trials (RCTs) investigating the effect of PUFAs in patients with DED before March 2019. Two reviewers independently abstracted data of tear breakup time (TBUT), Schirmer’s test, osmolarity, and ocular surface disease index (OSDI). We conducted pairwise meta-analysis using means and standard deviations (SDs) in a random-effects model for continuous outcomes. Thirteen eligible RCTs with 1782 patients with nonspecific typical DED were included. Patients who received PUFA treatment without other eye medications exhibited greater improvements in TBUT (MD = 1.80; p = 0.001), Schirmer test scores (MD = 0.50; p < 0.001), osmolarity (MD = −15.95; p < 0.001), and OSDI scores (MD = −10.19; p < 0.001) than those who received placebo treatment. However, the effects of PUFAs on TBUT (p < 0.001) and OSDI scores (p = 0.03) weakened with treatment duration. PUFAs are effective in treating nonspecific typical DED, particularly as a short-term treatment, with relatively few adverse events. Therefore, in real-world clinical practice, PUFA supplements are worth being suggested to patients with nonspecific typical DED who are not concurrently using other topical or systematic eye medications.

A Phase 3, Randomized, Double-Masked Study of OTX-101 Ophthalmic Solution 0.09% in the Treatment of Dry Eye Disease

To evaluate the safety and efficacy of OTX-101, a novel aqueous nanomicellar formulation of cyclosporine (0.09%), in the treatment of patients with dry eye disease (DED). A randomized, multicenter, vehicle-controlled, double-masked, phase 3 clinical trial. Adults (18-90 years of age) with a history and clinical diagnosis of DED, a global symptom score of 40 or more (range, 0-100), and a lissamine green conjunctival staining score of 3 or more and 9 or less (range, 0-12) in at least 1 eye. Eligible patients entered a run-in period of 14 to 20 days in which all patients administered vehicle twice daily. Patients who remained eligible at the baseline (day 0) visit were randomized in a 1:1 ratio to twice-daily treatment with OTX-101 0.09% or vehicle for 84 days. Efficacy assessments included signs (unanesthetized Schirmer tear test, corneal and conjunctival staining) and symptoms (global symptom score) of DED. The primary end point was the proportion of eyes with a clinically meaningful improvement (increase of ≥10 mm) in Schirmer test score at day 84. Safety evaluations included adverse events (AEs), visual acuity, and intraocular pressure monitoring, slit-lamp, dilated ophthalmoscopy, and fundus examinations. A total of 744 patients were randomized and received study medication (371 to OTX-101 0.09% and 373 to vehicle). The primary end point was achieved; a significantly greater percentage of eyes in the OTX-101 0.09% treatment group achieved an increase of 10 mm or more in the Schirmer test score at day 84 (OTX-101 0.09%, 16.6%; vehicle, 9.2%; P < 0.001). Significant improvements relative to vehicle also were observed for corneal (days 28, 56, and 84) and conjunctival (days 56 and 84) staining. The global symptom score was reduced from baseline in both treatment groups by approximately 30%; however, no significant separation between groups was observed. The OTX-101 0.09% formulation was well tolerated. Treatment-emergent AEs were primarily mild in intensity. Clinically and statistically significant improvements in tear production and ocular surface integrity were observed in patients treated with OTX-101 0.09% for DED.

A phase 2 randomized, double-masked, placebo-controlled study of novel nonsystemic kinase inhibitor TOP1630 for the treatment of dry eye disease.

PurposeTo evaluate the safety and efficacy of topical TOP1630, a novel nonsystemic kinase inhibitor, in dry eye disease (DED).Patients and methodsA randomized, double-masked, parallel-group trial of 0.1% TOP1630 ophthalmic solution TID or placebo (vehicle without active drug) was conducted in DED subjects (n=61). Key eligibility criteria consistent with enrolling a moderate to severe DED population included >6 months DED history; OSDI© score ≥18; Schirmer’s test score ≤10 and ≥1 mm/5 minutes; tear film break-up time >1 and <7 seconds; and dry eye exacerbation in corneal staining and ocular discomfort in a Controlled Adverse Environment (CAE®). After a 7-day run-in period with placebo TID, eligible subjects were randomized to TOP1630 or placebo for 28 days. No supplemental artificial tears or rescue medication were allowed.ResultsTOP1630 was safe, well-tolerated, and efficacious in treating DED symptoms and signs. No serious adverse events (AEs) or withdrawals due to treatment emergent AEs occurred. Drop comfort scores showed TOP1630 to be comfortable and comparable with placebo. Significant symptom improvements were seen for TOP1630 vs placebo for ocular discomfort (P=0.02 post-CAE), grittiness/foreign body sensation (on four independent assessment scales, each P<0.05), worst DED symptom (diary, P=0.06), and ocular pain (VAS, P=0.03). Sign improvements were seen for total ocular surface (all regions), corneal sum, and conjunctival sum staining with TOP1630 compared with placebo (each P<0.05).ConclusionTOP1630 had placebo-like tolerability and produced improvements in multiple symptom and sign endpoints in both environmental and challenge settings. The emergent TOP1630 benefit–risk profile for DED treatment is highly favorable and supports further development.

Expression of Nod-like Receptors and Clinical Correlations in Patients With Dry Eye Disease

To investigate the expression pattern of nucleotide-binding oligomerization domain (Nod)-like receptors that detects "danger" intracellular signaling and its correlation with clinical dry eye (DE) markers. Cross-sectional study. A total of 50 participants with 50 eyes were included: 23 eyes with Sjögren syndrome (SS)-DE, 14 eyes with non-SS-DE, and 13 healthy controls with non-DE. Ocular Surface Disease Index (OSDI) was self-answered and clinical tests including the tear film breakup time (TBUT), Schirmer test, and corneal fluorescein staining (CFS) were performed. Specimens for expression pattern analysis were obtained by conjunctival impression cytology and biopsy. Nod-1, inhibitor kappa B kinase-alpha (IκKα), and nuclear factor kappa B (NF-κB) expression was determined by reverse transcription quantitative real-time polymerase chain reaction and Western blot. Correlations between Nod-1 and ocular surface parameters were determined. Patients with SS-DE had significantly higher OSDI and CFS scores and lower TBUT and Schirmer test scores than those with non-SS-DE patients (all P < .05). Compared with the control group, both the SS-DE and non-SS-DE groups showed significant upregulation in mRNA expression levels of Nod-1 (relative 3.48-fold and 1.72-fold upregulation, respectively, P < .01), IκKα (relative 1.83-fold and 1.24-fold upregulation, respectively, P < .01), and NF-κB (relative 1.84-fold and 1.32-fold upregulation, respectively, P < .01). Western blot analysis showed that Nod-1 protein expression increased in both the SS-DE and non-SS-DE groups (relative 2.71-fold and 1.64-fold upregulation, respectively, P < .05) compared with that in the control group. Similar findings were observed for IκKα and NF-κB. In DE participants, the expression of Nod-1 significantly correlated with the OSDI (R2= 0.61, r= 0.78, P<.01), Schirmer test score (R2= 0.44, r= -0.66, P < .01), and CFS (R2= 0.46, r= 0.68, P < .01) but did not significantly correlate with TBUT (R2 <0.01, r= 0.08, P= .66). Nod-1 expression was increased in the conjunctiva of DE, especially SS-DE, and was associated with disease severity. Expression of Nod-like receptors might play an important role in initiating the inflammatory response in DE.

Randomized, Controlled, Double-Masked, Multicenter, Pilot Study Evaluating Safety and Efficacy of Intranasal Neurostimulation for Dry Eye Disease.

We assess the safety and effectiveness of intranasal neurostimulation to promote tear production via the nasolacrimal pathway in subjects with dry eye disease. A multicenter, randomized, controlled, double-masked pilot study was conducted in adults with dry eye diagnosis and at least one eye with corneal fluorescein staining ≥2 in at least one region or a sum of all regions ≥5 (National Eye Institute grading), basal Schirmer test score ≤10 mm, a cotton-swab stimulated Schirmer score ≥7 mm higher, and an Ocular Surface Disease Index score ≥23. Subjects were randomized to receive active intranasal neurostimulation or sham control intranasal stimulation 4 to 8 times per day. Assessments were scheduled before (unstimulated) and during (stimulated) device application at days 0, 7, 14, 30, and 90. The primary effectiveness endpoint was stimulation-induced change in Schirmer test (with anesthesia) score. Primary safety measure was incidence of device-related adverse events (AEs). Fifty-eight subjects were randomized at nine sites in Australia and New Zealand; 56 completed the 90-day study. Stimulation-induced change in Schirmer score was significantly greater with active intranasal (mean ± SEM, 9.0 ± 2.0) than sham control intranasal stimulation (0.4 ± 0.6; P < 0.001) at day 90. Similar results were observed at days 0, 7, 14, and 30 (P < 0.001). No serious device-related AEs were observed. Mild nosebleed, the most common device-related AE, was reported in five (16.7%) subjects. Intranasal neurostimulation was effective in inducing acute tear production after 90 days of use and generally was well tolerated in subjects with dry eye disease.

Comparison of modified Schirmer's test and clinical oral dryness score scale in the clinical assessment of oral dryness in postmenopausal women

Aims: The aim of this study was to assess the oral dryness in postmenopausal women and to correlate the salivary flow rate determined by modified Schirmer's test (MST) with the clinical oral dryness score (CODS) obtained from Challacombe Scale. Subjects and Methods: Forty postmenopausal women were questioned regarding their oral dryness status. Patients complaining of xerostomia formed the case group and rest formed the control group. CODS was assessed based on the ten features of oral dryness. Unstimulated whole salivary flow rate was assessed by MST. Statistical Analysis Used: All data were analyzed using inferential statistics such as Chi-square, Fisher's exact test, and Spearman correlation, and the analysis was carried out with SPSS 17. Results: There was statistically significant difference between case and control group with regard to CODS (P = 0.001) and modified Schirmer's (P = 0.004). A low-negative correlation was observed between modified Schirmer's score and CODS (r = -0.17). Conclusion: Since CODS correlated with modified Schirmer's score, it indicates that CODS can be utilized for semiquantitative assessment of oral dryness.

Ocular surface evaluation in pediatric Hashimoto's thyroiditis without thyroid-associated ophthalmopathy.

We aimed to assess ocular surface characteristics in children with Hashimoto's thyroiditis without thyroid-associated ophthalmopathy and compare the results with those of healthy children. Twenty-two children with Hashimoto's thyroiditis (Group 1) and 20 healthy children without any ocular and/or systemic disorder (Group 2) were enrolled in the study. Ocular Surface Disease Index questionnaire, tear film osmolarity measurement (TearLab Osmolarity System, San Diego, CA, USA), Schirmer and tear film breakup time tests, meibography, and conjunctival brush cytology were performed and compared the results between the groups. The study group included 19 girls and 3 boys in Group 1 and 12 girls and 8 boys in Group 2 (p=0.081). Thyroid-associated ophthalmopathy was not identified in any of the patients. Mean tear film osmolarity was 310.23 ± 11.98 mOsm/l in Group 1 and 313.60 ± 15.03 mOsm/l in Group 2 (p=0.424). Mean Schirmer test score was lower in Group 1 (14.91 ± 6.27) compared with Group 2 (23.60 ± 5.63) (p=0.001). Mean tear film breakup time was lower in Group 1 (11.78 ± 4.07) compared with Group 2 (15.1 ± 1.6) (p=0.013). Moreover, mean meibomian gland area loss was 25.01% ± 10.04% in Group 1 and 16.54% ± 6.02% in Group 2 (p=0.002). Conjunctival cytologic analysis in Group 1 revealed grade 0 changes in 6 patients (27.3%), grade 1 changes in 14 patients (63.6%), and grade 2 changes in 2 patients (9.1%), whereas 18 patients (90%) had grade 0 changes and 2 patients (10%) had grade 1 changes (p=0.001) in Group 2. The study demonstrates several ocular surface changes in children with Hashimoto's thyroiditis. These findings may indicate a tendency for dry eye in pediatric Hashimoto's thyroiditis patients without clinical evidence of thyroid-associated ophthalmopathy.

Characterization of tear production in subjects with dry eye disease during intranasal tear neurostimulation: Results from two pivotal clinical trials

PurposeThe intranasal tear neurostimulator (ITN) activates the nasolacrimal pathway, which is involved with basal and bolus tear secretion. These studies characterized the acute and long-term effectiveness of the ITN in stimulating tear production in subjects with dry eye disease (DED). MethodsStudy 1: Randomized, double-masked, dual-controlled, 1-day crossover. Study 2: Single-arm, open-label, 180-day prospective cohort. Eligible subjects had basal unstimulated Schirmer test (with anesthesia) ≤10 mm and intranasal cotton swab–stimulated Schirmer test at least 7 mm greater in the same eye, and Ocular Surface Disease Index® ≥13 and ≥ 23, in Studies 1 and 2, respectively. Study 1: Subjects (n = 48) received three randomized test applications: active intranasal, extranasal (active control), and sham intranasal (inactive control) stimulation, 3 min/application with 1-hour minimum between applications. Primary outcome measure was the difference in Schirmer test scores during active intranasal and control applications. Study 2: Subjects (n = 97) performed intranasal neurostimulation for ≤3 min/application, 2–10 times/day. Primary outcome measure was the difference in Schirmer scores (stimulated minus unstimulated) at day 180. Both studies recorded device-related adverse events (AEs). ResultsStudy 1: Schirmer scores (mean ± SEM) were significantly greater (p < 0.0001) with active intranasal (25.3 ± 1.5 mm) vs extranasal (9.5 ± 1.2 mm) and sham (9.2 ± 1.1 mm) applications. Study 2: Schirmer scores were significantly greater (p < 0.0001) with ITN stimulation vs unstimulated at day 180 (17.3 ± 1.3 mm vs 7.9 ± 0.7 mm). No serious device-related AEs were reported in either study. ConclusionThe ITN was well-tolerated and effective in stimulating tear production with acute and long-term use in DED. Clinicaltrials.gov identifierNCT02680158 and NCT02526290.

Sex hormone therapy's effect on dry eye syndrome in postmenopausal women: A meta-analysis of randomized controlled trials.

The purpose of the study to assess the efficacy of sex hormone therapy in the treatment of dry eye syndrome in postmenopausal women.The following electronic databases were searched without language restrictions: PubMed, Embase, Cochrane, and the Chinese Biomedical Database. Two reviewers collected all the literature, which was searched for relevance in English and Chinese from January 1990 to July 2017. Both of the reviewers screened documents independently, identifying the studies that met the inclusion criteria. Then, the included studies were evaluated, and the data were extracted and conversed dependently. Finally, Review Manager 5.3 (offered by the Cochrane collaboration) was used to complete the meta-analysis. An integrated mean difference (MD) with its corresponding 95% confidence interval (CI) was calculated.A total of 358 patients with dry eye were enrolled in 7 randomized controlled trials (RCTs). We observed statistically significant improvements in the Schirmer's test scores (MD, 2.06; 95% CI, 0.74–4.46; I2 = 97%; P = .006) after sex hormone treatment. However, the scores for tear breakup time (TBUT) (MD, 1.28; 95% CI, −1.03 to 4.68; I2 = 99%; P = .21) and the ocular comfort index (OCI) (MD, −1.12; 95% CI, −4.42 to 1.98; I2 = 95%; P = .48) were not improved.This meta-analysis of 7 RCTs suggests that sex hormone therapy may be associated with better Schirmer's test scores. However, no significant differences were detected in the TBUT and OCI test scores. Consequently, sex hormone therapy has a potentially useful role in the effective management of postmenopausal women with dry eye syndrome.