Assessment Of Dry Eye Symptoms Research Articles

Appropriateness of Questionnaires for the Diagnosis and Monitoring Treatment of Dry Eye Disease.

Objectives: If questionnaires contributing to the diagnosis of dry eye disease are to be recommended as alternatives to existing questionnaires, they must be comparable, with similar repeatability and treatment sensitivity. Comparability was thus examined for three common dry eye questionnaires along with identifying the individual questions that most strongly predicted overall scores. Methods: Anonymised data (n = 329) collected via the Ocular Surface Disease Index (OSDI), 5-item Dry Eye Questionnaire (DEQ-5) and Symptom Assessment in Dry Eye (SANDE) questionnaires (including responses to individual questions) from consenting patients were drawn from real-world dry eye clinics/registries in the United Kingdom, Australia and New Zealand; at follow-up, normalised changes were evaluated in 54 of these patients. Treatment data were also analysed from a 6-month, randomised controlled trial assessing artificial tear supplement treatments with 43 responders and 13 non-responders to treatment identified. The questions extracted from the OSDI which form the abbreviated 6-item OSDI were also analysed. Results: The agreement between the questionnaires ranged from r = 0.577 to 0.754 (all p < 0.001). For the OSDI, three questions accounted for 89.1% of the variability in the total score. The correlation between the OSDI and OSDI-6 was r = 0.939, p < 0.001. For the DEQ-5, two questions accounted for 88.5% of the variance in the total score. Normalised treatment changes were also only moderately correlated between the questionnaires (r = 0.441 to 0.595, p < 0.01). For non-responders, variability was 7.4% with both OSDI and OSDI-6, 9.7% with DEQ-5, 12.1% with SANDE-frequency and 11.9% with SANDE-severity scale. For responders, improvement with drops was detected with a 19.1% change in OSDI, 20.2% in OSDI-6, 20.9% in DEQ-5, and 27.5%/23.6% in SANDE-frequency/severity scales. Conclusions: Existing commonly used dry eye questionnaire scores do not show high levels of correlation. The OSDI was the least variable of the questionnaires and while displaying a slightly lower treatment effect than either the DEQ or SANDE, it was more sensitive to detection of a treatment effect. The quicker-to-complete OSDI-6 exhibited essentially the same outcome as the OSDI, with similar variability and treatment sensitivity.

Bilateral Sutureless Application of Human Dehydrated Amniotic Membrane with a Specialised Bandage Contact Lens for Moderate-to-Severe Dry Eye Disease: A Prospective Study with 1-Month Follow-Up.

To assess changes in symptoms and ocular surface signs following a bilateral sutureless treatment of dehydrated amniotic membrane (dAM) under a specialised bandage contact lens (sBCL) in patients with moderate-to-severe dry eye disease (DED). In this prospective pre-post interventional study, 35 patients diagnosed with moderate-to-severe DED, with an Ocular Surface Disease Index (OSDI) score >30 on current treatment, were enrolled. Assessments were conducted at baseline (day -30), after 30 days run-in with no additional treatment (day 0 - control), and 30 days post sBCL+dAM treatment (day 30 - treatment). Intervention involved two successive bilateral 4-5 day sutureless applications of dAM (17mm diameter, with a 6 mm central aperture, Omnigen® VIEW) under an 18mm sBCL (OmniLenz®). Symptomatology and ocular signs were measured using OSDI, Dry Eye Questionnaire-5 (DEQ-5), Symptom Assessment iN Dry Eye (SANDE), and other ocular surface health indicators including non-invasive breakup time, corneal and conjunctival staining, and lid wiper epitheliopathy length and width (LWE). While symptomatology remained stable during the 30-day no-treatment run-in, 1-month post-dAM treatment, there was a significant reduction in OSDI scores (from 55.8 to 32.3, p<0.001), DEQ-5 (from 14.6 to 10.0, p<0.001), SANDE frequency (from 65.2 to 43.6, p<0.001), and SANDE severity (from 59.8 to 41.1, p<0.001). Additionally, there was a notable decrease in the width of LWE staining, from grade 2 (50-75% of the lid wiper) to grade 1 (25-50% of the lid wiper) (p=0.011). A bilateral 8-10-day treatment duration with dAM applied with sBCL demonstrated a 31 to 42% improvement in symptomatology and a decrease in ocular surface signs of mechanical stress. This innovative bilateral treatment approach offers a promising treatment modality for patients with refractory moderate-to-severe DED.

The protective effect of vitamin A palmitate eye gel on the ocular surface during general anaesthesia surgery: a randomized controlled trial

PurposeTo investigate the change in tear production associated with general anesthesia and the protective effect of vitamin A palmitate eye gel on the ocular surface during general anesthesia.MethodsThis double-blind, randomized clinical trial included patients undergoing non-ophthalmic surgery under general anesthesia who randomly received vitamin A palmitate eye gel and taping for one eye (Group A, n = 60) or taping alone for the other eye (Group B, n = 60). Symptom assessment in dry eye (SANDE) score, tear film break-up time (TBUT), corneal fluorescein staining (CFS) score, and Schirmer tear test I (STT-1) were analyzed under a hand-held slit lamp before anesthesia (T0), 0.5 h postoperatively (T1), and 24 h postoperatively (T2).ResultsAt 0.5 h postoperatively, an increase in CFS score was observed in both groups (P < 0.05 in Group A and P < 0.01 in Group B), and the participants in Group A had less corneal abrasions than those in Group B. STT-1 significantly increased in Group A (P < 0.05), while it significantly decreased in Group B (P < 0.001). The changes between the two groups were statistically significant (P < 0.001). At 24 h postoperatively, both CFS score and STT-1 almost returned to baseline levels in the two groups. In both groups, the SANDE score and TBUT showed little change at 0.5 h and 24 h postoperatively (all P > 0.05).ConclusionVitamin A palmitate eye gel effectively protected the ocular surface and aqueous supplementation during general anesthesia.Trial registrationThis study was registered in the Chinese Clinical Trial Registry (ChiCTR2100052140) on 20/10/2021.

Diamond Bur Microblepharoexfoliation Combined with Intense Pulse Light and Meibomian Gland Expression for Evaporative Dry Eye: A Short-term Controlled Clinical Trial.

To assess the efficacy and safety of the combination of microblepharoexfoliation (MBE), intense pulse light (IPL) and meibomian gland expression (MGX) for treatment of meibomian gland dysfunction (MGD). This was a prospective, parallel-control trial conducted from April 2022 to January 2023. Participants were assigned to receive either three sessions of MBE-IPL-MGX treatment and home-based therapy (treatment group) or home-based therapy alone (control group). Outcome measures were assessed at baseline and after 2-month follow-up. Seventy eyes of 70 patients were enrolled. MBE-IPL-MGX treatment achieved better improvements than home-based therapy in ocular surface disease index (OSDI) and symptom assessment in dry eye (SANDE) scores, noninvasive tear film break-up time (NIBUT), lipid layer grade (LLG), loss area meibomian gland (LAMG) and meibomian gland yielding secretion score (MGYSS). The mean differences between the two groups were as follows: OSDI (- 11.23 ± 4.68 points, P < 0.001), SANDE (- 24.63 ± 13.41 points, P < 0.001), NIBUT (1.3 ± 1.57s, P = 0.033), LLG (0.4 ± 0.04 points, P = 0.003), LAMG (- 2.85 ± 1.69%, P = 0.023) and MGYSS (7.5 ± 2.32 points, P < 0.001). In addition, the increment (Δ) of MGYSS after MBE-IPL-MGX treatment was significantly higher in MGD grades 2 and 3 (all P < 0.001). MBE-IPL-MGX treatment is an effective and well-tolerated procedure that improves dry eye symptoms and signs as well as meibomian gland secretions in patients with MGD. In addition, this treatment is recommended for MGD grades 2 and 3.

Short-Term Efficacy of Ophthalmic Cyclosporine: A 0.1% Cationic Emulsion in Dry Eye Patients Assessed Under Controlled Environment.

To evaluate the short-term efficacy of cyclosporine A (CsA)-0.1% cationic emulsion (CE) in patients with dry eye disease (DED) and mitigation of the inflammatory flares triggered by desiccating stress environments. A single-center non-randomized clinical trial was performed at a tertiary care setting. Twenty patients with DED treated with CsA 0.1% CE were exposed to a normal controlled environment (NCE) (23°C, 50% relative humidity) and an adverse controlled environment (ACE) (23°C, 10% relative humidity, 0.43m/s localized airflow) during baseline and the 1- and 3-month visits. Patients underwent the following evaluations: conjunctival hyperemia and staining, corneal fluorescein staining (CFS) using the Oxford and Cornea and Contact Lens Research Unit (CCLRU) scale, meibomian gland (MG) secretion quality, Dry Eye Questionnaire-5, Symptom Assessment in Dry Eye (SANDE II), and Change in Dry Eye Symptoms Questionnaire. Multivariate models were adjusted for statistical analysis. Nineteen women and one man (mean age, 58.9 ± 12.3years) completed the study. All symptom questionnaires, CFS, conjunctival hyperemia and staining, and MG secretion quality improved (p ≤ 0.003) with 1month of treatment; improvements were maintained after 3months (p ≤ 0.02), except for SANDE II (p ≥ 0.07). The CFS worsening (total CCLRU) after baseline ACE exposure (from 8.6 to 10.1) was higher, although not significant (p = 0.64), compared with 1month (from 5.4 to 5.8) and 3months (from 5.0 to 5.9) after treatment. Topical CsA-0.1% CE improved DED signs and symptoms after 1month of treatment under controlled environmental conditions. Future studies should confirm the benefit of CsA-0.1% CE in desiccating stress environments. ClinicalTrials.gov identifier, NCT04492878.

The effect of a preservative-free prostaglandin analogue on the condition of the ocular surface in patients with glaucoma

PURPOSE. The study aimed to evaluate the antihypertensive effectiveness and the condition of the ocular surface in patients with glaucoma during monotherapy with the drug Traviolan® (travaprost 0.05%).METHODS. This longitudinal, randomized, prospective study included 27 patients (59.6% women, 40.4% men; mean age 64.1±6.4) with uncompensated primary open-angle glaucoma in early and moderate stages receiving mono-therapy with β-blockers or carbonic anhydrase inhibitors. This was a longitudinal, randomized, prospective, observational study. All patients underwent a complete ophthalmological examination and assessment of dry eye symptoms using a questionnaire (Ocular Surface Disease Index, OSDI). An objective assessment of the condition of the ocular surface was carried out using the Sirius corneal topography device, which is used for assessment of tear film breakup time (TBUT). All patients were re-examined after 12 weeks.RESULTS. Intraocular pressure was significantly reduced at all study visits and amounted to 5.9±2.8 mm Hg at week12 (25.9%). There was a significant reduction in symptoms of dry eye, irritation, itching, and foreign body sensation (p&lt;0.05 for each parameter). A significant improvement was also noted in terms of the condition of the ocular surface, and in most patients the symptom complex was classified as mild dry eye syndrome (p&lt;0.05). Additionally, there was also a significant improvement in the OSDI score (p&lt;0.05) with a mean of 17.95±5.35 points. The tear film breakup time by the end of observation increased by 4.1±2.3 sec and amounted to 7.4±3.1 sec.CONCLUSION. The drug Traviolan® has high antihypertensive effectiveness and good tolerability, and improves the condition of the ocular surface.

A combined treatment for patients with dry eye and associated laryngopharyngeal reflux: a real-life approach.

To evaluate the efficacy and tolerability of administering a combined therapy in patients with dry eye syndrome (DES) and associated laryngopharyngeal reflux (LPR). The study was retrospective, open, observational, and conducted in a real-life setting. Patients had pathological symptom assessment in dry eye (SANDE) and reflux symptom index (RSI) at baseline. Patients were re-assessed after 1mo and at the end of treatment. The treatment consisted of a three-month course based on the combined therapy: Gastroftal eye drops, one drop three times a day, and Gastroftal tablets, two tablets after lunch and two tablets after dinner. Tear break-up-time (TBUT) test, Schirmer test, RSI, and SANDE questionnaire were evaluated. The study included 253 patients. The mean age was 58±11.19y. TBUT test score and Schirmer's test significantly increased (both P<0.001) after 1mo and at the end of treatment. The RSI score and SANDE scores significantly decreased (both P<0.001) after 1mo and at the end of treatment. The current, retrospective, and open study shows that combined therapy using Gastroftal eye drops and tablets could represent a valuable option in managing patients with DES associated with LPR.

Comparison of the Ocular Surface Disease Index and the Symptom Assessment in Dry Eye Questionnaires for Dry Eye Symptom Assessment.

Patient-reported dry eye symptoms (DESs), assessed using the Ocular Surface Disease Index (OSDI) and the Symptom Assessment iN Dry Eye (SANDE) questionnaires, were compared in a large sample of patients. The correlation (Spearman coefficient) and agreement (Bland-Altman analysis) between the OSDI and SANDE questionnaire scores (with and without score normalization) were assessed in 1033 patients and classified according to the OSDI score as non-DES and DES in a cross-sectional analysis. The normalized and non-normalized SANDE results were higher than the OSDI results in all samples (2.83 ± 12.40 (p = 0.063) and 2.85 ± 15.95 (p = 0.016), respectively) and in non-DES (p > 0.063) and DES (p < 0.001) with both OSDI cutoff values. Weak correlations were found (Spearman coefficient <0.53; p < 0.001) in all cases except DES (0.12, p = 0.126). Weak agreement was found with a Bland-Altman analysis of the normalized and non-normalized scores of both questionnaires (mean difference from -7.67 ± 29.17 (DES patients) to -1.33 ± 8.99 (non-DES patients) without score normalization, and from -9.21 ± 26.37 (DES patients) to -0.85 ± 4.01 (non-DES) with data normalization), with a statistically significant linear relationship (R2 > 0.32, p < 0.001). The SANDE questionnaire did not yield the same patient classification as OSDI. The same operative curves (ROC) of the SANDE normalized and non-normalized scores were used to differentiate among patients with DES using OSDI < 12 (0.836 ± 0.015) or OSDI < 22 (0.880 ± 0.015) cutoff values. Normalized and non-normalized data collected from the SANDE questionnaire showed relevant differences from those of the OSDI, which suggests that the results of the SANDE visual analog scale-based questionnaire provide different patient classifications than the OSDI score.

Environmental Effects on Dry Eyes in Primary Sjogren&amp;apos;s Syndrome

Purpose: To investigate the effects of humidity, temperature, and fine particulate matter (PM&lt;sub&gt;2.5&lt;/sub&gt;) on dry eye disease (DED) parameters in primary Sjogren's syndrome patients.Methods: We retrospectively analyzed the medical records of 18 primary Sjogren's syndrome patients who underwent DED treatment and had more than two follow-up visits. Symptom Assessment in Dry Eye (SANDE) scores, tear secretion, tear film breakup times, ocular surface staining scores, and tear osmolarity were assessed. Temperature, humidity, and PM&lt;sub&gt;2.5&lt;/sub&gt; concentrations during the week before the patient visits were calculated using public data and their relationships with DED parameters were analyzed.Results: All patients were females, with an average age of 57.6 ± 12.4 years. High temperature was significantly correlated with humidity and PM&lt;sub&gt;2.5&lt;/sub&gt; concentration (&lt;i&gt;p&lt;/i&gt; = 0.004 and = 0.006, respectively). The high humidity, high temperature, and low PM&lt;sub&gt;2.5&lt;/sub&gt; groups had lower SANDE scores (&lt;i&gt;p&lt;/i&gt; = 0.017, = 0.063, and = 0.049, respectively) and tear osmolarity (&lt;i&gt;p&lt;/i&gt; &lt; 0.001, = 0.009, and &lt; 0.001, respectively). Multiple regression analysis showed that temperature and humidity had stronger correlations with tear osmolarity (&lt;i&gt;p&lt;/i&gt; = 0.005 and = 0.012, respectively) compared to PM&lt;sub&gt;2.5&lt;/sub&gt; concentrations.Conclusions: Ocular discomfort and tear osmolarity were correlated with temperature, humidity, and PM&lt;sub&gt;2.5&lt;/sub&gt; concentrations. Among the DED parameters, tear osmolarity was the most sensitive indicator of exposure to environmental factors.

Correlation and Level of Agreement between the Ocular Surface Disease Index and the Symptom Assessment in Dry Eye Questionnaires: A Survey-Based Study

Purpose The Ocular Surface Disease Index (OSDI) is the most frequently used dry eye disease (DED) questionnaire, and the Symptom Assessment iN Dry Eye (SANDE) is the simplest and quickest to apply. We analyze the correlation and level of agreement between these two questionnaires in a large DED heterogeneous population to evaluate their performance and potential interchangeability. Methods Prospective, multicenter longitudinal survey-based study performed on patients diagnosed with DED by 99 ophthalmologists from 20/32 Mexican states. Questionnaires were applied in two consecutive visits to analyze the correlation between OSDI and SANDE to evaluate patients with DED clinically. Level of agreement was evaluated with Bland-Altman analysis, and internal consistency of instruments was evaluated individually and combined with Cronbach’s alpha index. Results 3421 patients studied: 1996 (58.3%) women and 1425 (41.7%) men, aged 49.5 ± 15.4 years; 995 (29.1%) patients had aqueous-deficient, 1086 (31.7%) evaporative, and 1340 (39.2%) mixed DED subtypes. Normalized baseline scores were 53.7 (OSDI) and 54.1 (SANDE). After 36.3 ± 24.4 days between visits, scores were reduced to 25.2 (OSDI) and 21.8 (SANDE) points (p < .001). A positive correlation between questionnaires was found at baseline (R = 0.592; p < .001), follow-up (R = 0.543; p < .001) and change between visits (R = 0.630; p < .001). Using both questionnaires together improved the overall reliability of symptom evaluation at baseline (α = 0.7), follow-up (α = 0.7), and both (α = 0.7), compared to individual application (OSDI α = 0.5, SANDE α = 0.6)—the same improvements applied to all DED subtypes. Bland-Altman analysis revealed a differential bias of -0.41% at baseline and +3.6% at follow-up visits between OSDI and SANDE. Conclusions We validated the correlation (high precision) between questionnaires in a large-scale population, demonstrating improved reliability (high accuracy) in evaluating DED when used together, challenging their interchangeable use. These results open a venue to improve recommendations toward a more precise and accurate diagnostic and therapeutic evaluation of DED by using OSDI and SANDE concurrently.

Proteomic analysis of tears in dry eye disease: A prospective, double-blind multicenter study

PurposeTo identify specific dry eye disease (DED) tear biomarker(s) using tear proteomic analysis, clinical parameters, and their correlations before and after DED treatment. MethodsA prospective, double-blinded, national multicenter clinical study was performed using data from 80 DED patients. The patients were treated with 0.1% cyclosporine (CsA, n = 28), 0.05% CsA (n = 26), or 3% diquafosol (DQS, n = 26) eye drops, and tear proteome changes and clinical outcomes (tear break-up time [TBUT], corneal erosion [Cor-Er], conjunctival erosion [Conj-Er], and symptom assessment in dry eye [SANDE] scores) were observed at 4, 8, and 12 weeks. For all clinical parameters, correlation analysis was performed between the three drug conditions and the differentially expressed proteins (DEPs) from the proteomic analysis. ResultsAFM, ALCAM, CFB, H1-4, PON1, RAP1B, and RBP4 were identified in all treatment groups and were downregulated after treatment. All clinical parameters significantly improved at 12 weeks than at baseline (p-value <0.0001); however, their values were not significantly different among groups, except for Cor-Er (p-value = 0.007). Compared with the DQS group, Cor-Er score significantly improved after treatment with 0.1% and 0.05% CsA. The seven DEPs identified in all groups were not consistently correlated with the clinical parameters (p-value >0.05). ConclusionsDespite differences in drug concentration and action mechanisms, the improvement levels of TBUT, Cor-Er, and SANDE scores were clinically adequate. However, useful tear protein biomarkers, clinically acceptable biomarker combinations correlating with clinical parameters, and clinically acceptable levels of specificity and sensitivity were not identified.

Clinical evaluation of dry eye in type 2 diabetes mellitus: A hospital-based study from Eastern India

Abstract Background: The burden of dry eye in Indian patients with type 2 diabetes mellitus is not well documented. Methods: A hospital-based cross-sectional clinical study was conducted in a tertiary healthcare centre in Eastern Odisha on 100 T2DM patients from January 2017 to January 2019 to study the burden of dry eye. A detailed history of presenting symptoms, duration, progression and any associated condition, if present, were recorded. A detailed history regarding diabetes mellitus and treatment was recorded. The assessment of dry eye symptoms of patients was made using a questionnaire. The comprehensive ocular surface evaluation examination included visual acuity, and anterior segment examination included corneal surface, height of tear meniscus, pre-corneal tear film, tear film break-up time (TBUT) and Schirmer’s test. Results: Their mean age was 53.7 ± 9.8 years; there were 54 were males. Sixty-two patients had complaints of dry eye. Mild, moderate and severe dry eye were noted in 31, 22 and 9 patients, respectively. Twenty-six patients with mild dry eye disease were noted with glycosylated haemoglobin HbA1c (%) levels between 6.1 and 7, and eight patients with severe dry eye disease had HbA1c 8%. TBUT was found to decrease as the severity of dry eye increased. Conclusions: In the present study, a strong association was found between T2DM and dry eye. It is necessary to examine the ocular surface routinely in DM patients for early detection of dry eye and prevention of structural damage to the ocular surface.

Effectiveness of Topical Cyclosporin A 0.1%, Diquafosol Tetrasodium 3%, and Their Combination, in Dry Eye Disease.

Purpose: To compare the effectiveness of the topical use of cyclosporin A (CsA) 0.1%, diquafosol (DQS) tetrasodium 3% ophthalmic solution, and their combination in treating dry eye disease in a general health care setting. Methods: This prospective, nonrandomized, observational study analyzed 279 patients. Patients instilled topical CsA 0.1% (Ikervis®; Santen Pharmaceutical Co., Ltd., Japan) once daily and/or DQS tetrasodium 3% (Diquas-S®; Santen) six times a day for 12 weeks. Objective signs [tear break-up time (TBUT), National Eye Institute (NEI) corneal and conjunctival staining scores] and symptoms [Symptom Assessment in Dry Eye (SANDE) and Dry Eye-related Quality-of-Life Score (DEQS) questionnaires] were evaluated at baseline, week 4, and week 12. Results: Patients (n = 279) were mainly female (85.0%) with a mean (SD) age of 50.1 (14.8) years, and received CsA (n = 93), DQS (n = 99), or CsA/DQS (n = 87). Both monotherapies and CsA/DQS combination therapy significantly improved TBUT, NEI corneal and conjunctival staining scores, and SANDE and DEQS scores from baseline to week 12 (all P < 0.0001). The mean change in TBUT between baseline and week 12 was significantly higher in CsA/DQS combination therapy (2.13 ± 2.41 s) than in CsA monotherapy (1.07 ± 1.71 s; P = 0.0011). Conclusions: Monotherapy with CsA or DQS and CsA/DQS combination therapy all significantly improved the objective signs and symptoms of dry eyes during 12 weeks of treatment. CsA/DQS combination therapy provides an additional benefit in terms of TBUT compared with CsA alone; however, a randomized controlled trial still needs to be performed to confirm this result.

Effect of OTX-101 in Patients with Dry Eye Disease at Day 14 of Treatment: Ocular Surface Endpoint Results from the Phase 2b/3 Clinical Trial.

Dry eye disease (DED) is a multifactorial disorder characterized by loss of tear film homeostasis, which initiates a cycle of ocular surface inflammation and damage. As ocular discomfort symptoms associated with DED can decrease quality of life, affected patients prefer treatments that rapidly improve the underlying disease process. OTX-101 0.09% (CEQUA®) is indicated to increase tear production in patients with DED. The current analysis assessed early efficacy of OTX-101 0.09% in adult patients with bilateral DED by evaluating ocular surface endpoints after 14 days of treatment in the phase 2b/3 trial. In this randomized, double-masked, vehicle-controlled, dose-ranging study, patients received one drop of OTX-101 0.05%, OTX-101 0.09%, or vehicle per eye twice daily for 84 days. Corneal staining, conjunctival staining, tear breakup time (TBUT), and modified Symptom Assessment iN Dry Eye (SANDE) total global symptom score were assessed at baseline and Days 14, 28, 42, 56, and 84/early discontinuation. Overall, 455 patients were randomized (OTX-101 0.05%, n=151; OTX-101 0.09%, n=152; vehicle, n=152); only baseline and Day 14 results for the approved OTX-101 0.09% formulation and vehicle are presented. Least squares (LS) mean (standard error [SE]) change from baseline in conjunctival staining score was -1.3 (0.1) for OTX-101 and -1.0 (0.1) for vehicle. LS mean (SE) change from baseline in corneal staining score was -1.1 (0.17) for OTX-101 and -0.7 (0.17) for vehicle. LS mean (SE) change from baseline in TBUT was 0.52 (0.15) for OTX-101 and 0.36 (0.15) for vehicle. LS mean (SE) change from baseline in modified SANDE total global symptom score was -4.93 (1.54) for OTX-101 and -9.1 (1.54) for vehicle. OTX-101 0.09% demonstrated a numerically greater treatment effect compared with vehicle in conjunctival staining, corneal staining, and TBUT after 14 days.

Clinical Efficacy, Tolerability and Safety of a New Multiple-Action Eyedrop in Subjects with Moderate to Severe Dry Eye.

Background: To assess the clinical efficacy, tolerability and safety of a new-generation ophthalmic solution containing cross-linked hyaluronic acid 0.15% trehalose 3%, liposomes 1% and sterylamine 0.25% (Trimix® Off Health Italia, Firenze, Italy) (CXHAL) versus trehalose 3% (Thealoz®, Thea Pharmaceuticals, Clermont-Ferrand, France) (TRS) in subjects with moderate to severe dry eye disease (DED). Patients and methods: In this prospective, observational cohort study, 41 subjects with moderate to severe dry eye were enrolled and divided into two age- and sex-matched groups. Group 1 was treated with CXHA eye drops, and group 2 was treated with TRS eye drops four times daily for 2 months. All subjects were evaluated at baseline (V0) and at day 60 ± 3 (V1). The examination comprised Best Corrected Visual Acuity (BCVA) and Symptom Assessment in Dry Eye (SANDE). Tear osmolarity was evaluated using the TearLab Osmolarity System®; Keratograph 5M (Oculus, Wetzlar, Germany) was performed to assess tear meniscus height (TMH), fluorescein tear break-up time (TBUT) and corneal and conjunctival fluorescein staining and meibography; furthermore, slit lamp evaluation was performed for eyelid erythema and edema, conjunctival chemosis and hyperemia and Meibomian gland secretion quality. Results: All patients completed the treatment. BCVA remained stable in both groups, and no adverse events were reported. After 2 months, both groups showed statistically significant improvements for SANDE (p = 0.001 and p = 0.012, respectively), TBUT values (p &lt; 0.001 and p &lt; 0.001, respectively) and staining (p = 0.004 and p = 0.001, respectively) as compared to baseline values. Group 1 showed a statistically significant improvement in SANDE frequency and tear osmolarity (p = 0.02 and p = 0.001, respectively), whereas chemosis was significantly reduced in group 2. The amount of TBUT improvement was statistically higher in group 1 compared to that in group 2 (p = 0.041). Conclusion: A new-generation multiple-action ophthalmic solution was safe and clinically effective in the treatment of moderate and severe dry eye, with significant improvements in the main ocular surface parameters.

Combined intense pulsed light and low-level light therapy for the treatment of refractory Meibomian gland dysfunction.

To evaluate the efficacy of combined Intense Pulsed Light (IPL) and Low-Level Light Therapy (LLLT) in treatment of Meibomian Gland Dysfunction (MGD). In this prospective study, 70 patients with refractory MGD were enrolled; group 1 received 3 consecutive sessions of IPL + LLLT treatment using Eye-light® on day 1, day 15 and day 45; group 2 received hyaluronate sodium 2 mg/ml drops 3 times a day for 6 months. Patients underwent at baseline, and after 3 and 6 months Ocular Surface Disease Index (OSDI) questionnaire, Symptom Assessment in Dry Eye (SANDE), tear-film breakup time (TBUT), fluorescein ocular surface staining, meibum expressibility and quality evaluations. Keratograph 5M (Oculus, Germany) was used to assess NIBUT, tear meniscus height (TMH), meibography, and bulbar redness score. At 6 months a significant improvement of OSDI (p = 0.03), SANDE (p = 0.02), NIBUT (p = p < 0.0001), TMH (p = 0.04), TBUT (p = 0.02), corneal-conjunctival staining score (p = 0.02), lid margin score (p < 0.0001), and bulbar redness score (p = 0.001) were recorded in group 1. Comparing the two groups, statistically significant differences were observed at 6 months in TBUT (p = 0.03), lid margin score (p < 0.001), Meibum expressibility (p = 0.03) and NIBUT (p < 0.001). No adverse events were recorded throughout the follow-up period. This study confirmed the efficacy and safety of combined IPL and LLLT demonstrating its superiority compared to topical treatment.

Effects of different eye protection methods during head and neck surgery under general anesthesia

Objective: To compare the protective effects of vitamin A eye gel combined with 3M transparent tape and erythromycin eye ointment combined with 3M transparent tape on the eye surface during head and neck surgery under general anesthesia. Methods: From June to December 2021, a total of 120 patients undergoing elective head and neck surgery under general anesthesia in Beijing Tongren Hospital, Capital Medical University were enrolled. Each participant was randomly received vitamin A eye gel (vitamin A eye, n=60) or erythromycin eye ointment (erythromycin eye, n=60), followed by 3M transparent tape on one eye, and taping 3M transparent tape alone for the other eye. The hand-held slit lamp examination was performed 3 times at before induction of anesthesia, after resuscitation in the post anesthesia care unit (PACU) and 1 day after surgery. The primary outcome was corneal fluorescein sodium staining (CFS) score. Secondary outcomes included symptom assessment in dry eye (SANDE) questionnaire score, basic tear secretion test (Schirmer I test, SIt), break-up time (BUT) and incidence of adverse reactions. Results: Comparison within groups showed that CFS scores were significantly higher in vitamin A eyes and erythromycin eyes at PACU than before induction (P<0.05). Comparison between groups showed that CFS score at PACU in erythromycin eyes (0.62±0.16) was significantly higher than that in vitamin A eyes (0.13±0.01, P=0.007). Compared with before induction, SIt at PACU was significantly increased in the erythromycin eyes [(16.0±1.3) vs (11.4±4.9) mm, P=0.017],and was significantly decreased in vitamin A eyes [(10.2±3.6) vs (12.4±5.5) mm, P=0.046]. The BUT in PACU of erythromycin eyes, vitamin A eyes were (6.4±2.5) s, (6.8±2.1) s, respectively,and were significantly decreased compared with before induction (P<0.05). Comparison between groups showed that there was no significant difference in BUT and SANDE in PACU between two groups (P>0.05). For erythromycin eyes, discomfort symptoms in PACU included viscosity (66.7%, 40/60), conjunctival congestion (21.7%, 13/60), tingling (8.3%, 5/60), blurred vision (58.3%, 35/60). The incidence of these complications in vitamin A eye was 30.0% (18/60), 5.0% (3/60), 0 and 6.7% (4/60), respectively, and all the incidences were significantly higher than those of vitamin A eyes (all P<0.05). Conclusion: For patients undergoing head and neck surgery under general anesthesia, the combination of vitamin A ocular gel and 3M transparent tape is more effective in prevent postoperative ocular surface injury than the combination of erythromycin ointment and 3M transparent tape.

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

PurposeTo compare TearCare and Lipiflow systems in the ability to reduce the symptoms of dry eye disease (DED) associated with meibomian gland dysfunction (MGD).MethodsIn 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).ResultsTearCare 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, pANCOVA = 0.0160), OSDI Section B score for quality of vision (5.1 ± 0.48 and 3.6 ± 0.45, respectively, pANCOVA= 0.0206), and SANDE frequency score (51.9 ± 3.70 and 41.5 ± 3.45, respectively, pANCOVA = 0.0455).ConclusionTearCare 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 NumberNCT03857919.

Results from a Prospective, Open-Label, Phase 4 Pilot Study of Repository Corticotropin Injection for Moderate and Severe Dry Eye Disease.

IntroductionThere is a substantial unmet need for effective therapies to treat patients with refractory dry eye disease (DED). The goal of this open-label pilot study was to investigate the efficacy and safety of repository corticotropin injection (RCI; Acthar® Gel; Mallinckrodt Pharmaceuticals) in subjects with DED, most of whom did not experience adequate response to standard-of-care therapies.MethodsAdults with moderate or severe-acute DED received 80 U of subcutaneous RCI twice weekly for 12 weeks. Primary efficacy outcomes were improvements in corneal fluorescein staining of superficial punctate keratitis (SPK) lesions and Symptom Assessment in Dry Eye (SANDE) scores. Secondary outcomes included changes in Schirmer’s test scores, conjunctival lissamine green staining, erythema, intraocular pressure (IOP), and best corrected visual acuity (BCVA). Adverse events (AEs) were assessed continuously throughout the study.ResultsFifteen subjects received at least 1 dose of RCI, and 12 subjects completed the study. Compared to baseline (day 1), significantly fewer fluorescein-stained SPK lesions were detected at day 14 (p = 0.0250) and day 84 (p = 0.0240) after RCI treatment. Mean SANDE scores progressively declined from 62.0 at baseline to 46.9 at day 84. Erythema (p = 0.0046), conjunctival lissamine green staining of SPK lesions (p = 0.0317), and IOP (p = 0.0052) were all significantly improved after 12 weeks of RCI therapy. Schirmer’s test scores and BCVA showed no significant changes throughout the study. No ocular AEs or deaths occurred, and no new safety signals were identified for RCI.ConclusionsThese results suggest that RCI may be a safe and effective treatment for moderate and severe DED.Trial registrationClinicalTrials.gov identifier: NCT03287635.

Relationships between Symptoms and Signs of Dry Eye Using Symptom Assessment in Dry Eye Questionnaires

Purpose: To investigate the pattern of Symptom Assessment in Dry Eye (SANDE) questionnaire symptom scores in dry eye disease (DED) patients and to assess the relationships with several dry eye signs.Methods: The medical records of 173 patients with DED were analyzed retrospectively. Each patient’s SANDE score and history of autoimmune disease and ocular surgery were investigated, and Schirmer’s test, tear film breakup time (TBUT), ocular surface staining score (OSS), tear osmolarity, and tear MMP-9 test were assessed. The distribution of SANDE scores and relationships between the SANDE score and various dry eye signs were analyzed. The relationships between the SANDE scores of TBUT (&lt; 5 / ≥ 5) and OSS (&lt; 3 / ≥ 3) subgroups were compared.Results: The average SANDE score was 52.6 ± 28.1. The SANDE scores were significantly higher in OSS ≥ 3 than in OSS &lt; 3 (79.1 ± 21.6 vs. 51.1 ± 27.6, p = 0.030), and TBUT ≥ 5 had marginally significantly lower SANDE scores than TBUT &lt; 5 (47.2 ± 25.6 vs. 55.6 ± 29.0, p = 0.050). TBUT was significantly negatively (R = -0.151, p = 0.024) correlated with the SANDE score, while OSS was marginally significantly positively (R = 0.111, p = 0.073) correlated. As OSS increased, the SANDE scores tended to increase (p for trend = 0.008). Other dry eye signs were not associated with the SANDE score.Conclusions: The DED symptom score from the SANDE questionnaire was related to TBUT and OSS, but there was still a discrepancy between the symptoms and signs of DED.