A randomised study comparing performance and safety of Eyestil Plus® vs Vismed Multi® in moderate-to-severe dry eye syndrome patients.

PURPOSE: This clinical investigation compared the performance and safety of Eyestil Plus® (SIFI) and Vismed Multi® (TRB Chemedica) for reducing keratitis lesions in moderate-to-severe dry eye disease (DED) patients. MATERIALS AND METHODS: This was a randomised, double-blind, multicentre investigation. 96 adults (>18 years of age) with moderate-to-severe DED received Eyestil Plus® (N = 48) or Vismed Multi® (n = 48) 6 times daily for 3 months. The primary objective clinical performance after 1 month as global corneal and conjunctival staining scores. The secondary objectives were clinical performance after 3 months, tear film stability (tear break up time (TBUT), tear production (Schirmer test), patient-reported outcomes (PROs), investigator satisfaction, and safety. RESULTS: 96 participants were randomised to receive the clinical investigations' treatments, 82.3% of them were female and their mean age was 65.8 years. The non-inferiority of Eyestil Plus® for moderate-to-severe DED was demonstrated at 1 month. No statistical difference was found for any of the study's objectives: change at 1 and 3 months of the global corneal and conjunctival staining score (p-value = 0.506 and 0.661, respectively), change at 1 and 3 months (p-value = 0.538 and 0.302) for TBUT test; change at 3 months for Schirmer test (p-value = 0.540). There were no changes for PROs either. Investigator satisfaction was high for both products. 16.6% of the participants experienced adverse events. CONCLUSION: This clinical investigation showed the non-inferiority of Eyestil Plus® compared to Vismed Multi® regarding performance and safety in a moderate-to-severe DED population.

Unveiling Unilateral Bell's Palsy: A Case Series.

Bell's palsy is an idiopathic and uncommon peripheral nerve palsy that affects the facial nerve, leading to an inability to control the muscles of facial expression on the affected side. This paper presents two cases of unilateral Bell's palsy in female patients treated with systemic steroids, antiviral drugs, and artificial tear substitutes. The treatment outcomes, clinical course, and recovery timelines are discussed in detail. A review of the current literature on the etiology, diagnosis, and management of Bell's palsy is also provided to contextualize these cases within broader clinical practice.

Paper-based Electrochemical Sensor Integrated with Gold Nanoparticle-Decorated Carbon Cloth as a Working Electrode for Nitric Oxide Detection in Artificial Tears.

Nitric oxide (NO) in human tears regulates numerous ocular surface processes, such as tear generation, corneal wound healing, conjunctival vascular tone, and so forth. Any deviation from its normal concentration is linked to various ocular syndromes, including microbial keratitis, conjunctivitis, pterygium, dry eye, retinitis, glaucoma, and so forth. Therefore, precise monitoring of NO in tears can be considered as a potential biomarker for ocular diseases. Here, we report a highly sensitive and selective electrochemical NO sensor using carbon ink-based electrodes. Counter, working (WE), and reference electrodes have been designed and painted on a butter paper by using carbon ink. To improve the sensing performance, the WE has been modified with a gold nanoparticle (Au NP)-deposited carbon cloth (CC). Such a paper-based sensor demonstrated high sensitivity of ∼0.34 µA µM-1 cm-2, ultralow detection limit of ∼2.35 nM, wide linear range of 10 nM-0.4 mM, and fast response time (0.35 s). The sensor also showed excellent stability and selectivity toward the interfering agents in human body fluids. Such a low-cost, flexible paper-based sensor was employed for the detection of NO in artificial tears.

Effect of Artificial Tears on Preoperative Keratometry and Refractive Precision in Cataract Surgery.

Purpose: The primary objective was to investigate if treatment with artificial tears affected the variability of keratometry measurements for subjects with dry eyes prior to cataract surgery. The secondary objectives were to investigate whether treatment with artificial tears improved refractive precision and whether subjects with non-dry eyes had better refractive precision than subjects with dry eyes. Design: Prospective randomized controlled trial with three arms. Patients and methods: Dry eye diagnostics according to DEWS II were performed, and subjects with dry eyes were randomized to no treatment (group A1) or treatment with artificial tears two weeks prior to cataract surgery (group A2), with the third group (Group B, non-dry eyes) as a control. Keratometry was performed twice at baseline and twice after two weeks at the time of cataract surgery with three different optical biometers. The change in mean variability of keratometry (average K and magnitude of vector differences) and percentages of outliers after two weeks versus baseline were compared for group A2. The refractive and astigmatism prediction errors were calculated eight weeks after cataract surgery and compared for all three groups. Results: One hundred thirty-one subjects were available for analysis. There was no statistically significant difference in the mean variability of keratometry or percentages of outliers for group A2 from baseline to the time of cataract surgery. There was no statistically significant difference in refractive precision (absolute error and astigmatism prediction error) between any groups. Conclusion: Subjects with dry eyes (treated and non-treated) achieved the same refractive precision and percentages of outliers as subjects with non-dry eyes. Treatment with artificial tears for two weeks appeared inadequate to significantly affect variability in biometric measurements for patients with dry eyes prior to cataract surgery. DEWS II criteria for DED may not be optimal in a cataract setting.

Efficacy and safety of artificial tears containing Artemia salina extract with dinucleotides for dry eye.

CLINICAL RELEVANCE: This clinical trial was conducted as part of the marketing procedures for a medical device comprising artificial tears containing Artemia salina extract with dinucleotides. These molecules previously demonstrated secretagogue properties by enhancing the production of aqueous, mucinous, and lipidic components of the tears. BACKGROUND: After confirming the efficacy of artificial tears containing Artemia salina extract in an animal model, this study proceeded to evaluate their efficacy and safety on dry eye participants. METHODS: A randomised controlled clinical trial was performed on 36 dry eye participants (41.6 ± 20.6 years). Half of the participants were treated with saline solution as a placebo for four weeks, while the other half were treated with artificial tears containing Artemia salina, randomly assigned. After a wash-out period of two weeks, the treatments were crossed for another four weeks. Participants were assessed at baseline and after one week, two weeks, and four weeks. Efficacy variables were: eye dryness frequency (primary), eye comfort, visual satisfaction, tear secretion, tear break-up time, corneal staining, conjunctival staining, and conjunctival hyperaemia. Safety variables were: high- and low-contrast visual acuity, intraocular pressure, and eye fundus images analysis. RESULTS: Compared with the baseline, the saline solution showed no significant changes in any of the studied variables after four weeks of treatment (p ≥ 0.05). However, the topical instillation of the artificial tears with Artemia salina for four weeks significantly improved eye dryness frequency (p = 0.014) and corneal staining (p = 0.010). No systemic or ocular adverse events were reported during the clinical trial. CONCLUSION: The topical instillation of artificial tears containing Artemia salina in mild to moderate dry eye participants for four weeks slightly improved their symptoms related to eye dryness frequency and reduced corneal damage, with no undesirable side effects observed.

Tear film stability in patients with symptoms of dry eye after instillation of dual polymer hydroxypropyl guar/sodium hyaluronate vs single polymer sodium hyaluronate.

PURPOSE: This study evaluated the tear film stability in patients with symptoms of dry eye after installation of dual polymer hydroxypropyl guar/sodium hyaluronate (DPHG/SH) vs single polymer SH. METHODS: Patients with recently diagnosed mild to moderate dry eye disease (OSDI score 23-32 points) were included. For each patient, the right eye was randomized to receive DPHG/SH or 0.15% SH. Just after the administration of the drop to the right eye, the fellow eye received the other eye drop. The first non-invasive Keratograph first break-up time (NIKBUT), average NIKBUT and tear meniscus height (TMH) were measured before administration of the eye drops, at 1-min, 15 min, 30 min, 60 min, 90 min, and 120 min after instillation. RESULTS: A total of 29 patients aged 22.8 ± 2.2 years participated in the study (21 women). No differences between the eye receiving DPHG/SH and single polymer SH were observed for the first NIKBUT (p = 0.45) and average NIKBUT (p = 0.24) variables at any time point. Both DPHG/SH and single polymer SH increased the TMH (p of time effect < 0.001), but with no difference between groups (p = 0.95). CONCLUSION: Both DPHG/SH and single polymer SH solutions provide lubrication of the eye surface, however, with no difference in NIKBUT and TMH evaluations for up to two hours following administration.

Evaluation of cyclosporine 0.05% and artificial tears for the management of dry eye disease following cataract surgery: a randomized controlled trial.

Purpose: To compare the effects of cyclosporine 0.05% and artificial tears on dry eye disease following cataract surgery. Methods: This prospective, double-masked, randomized clinical trial enroled 60 eyes of 60 eligible cataract patients who completed the study. Patients were randomized to receive either cyclosporine 0.05% or artificial tear four times daily for 1 month following cataract surgery. Clinical assessments included refraction, corrected distance visual acuity, tear break-up time (TBUT), Schirmer's test, and the visual analogue scale (VAS). An independent sample t-test was used to compare the means of the variables between the two groups. Results: Mean patient age was 64.15±9.17 (range, 45-90), of which 53% (n=32) were female. There was no significant difference in mean age (P=0.308) between the two groups. One month postoperatively, the cyclosporine 0.05% group had a significantly higher TBUT value (P=0.004). Schirmer's result (P=0.095) and the VAS questionnaire scores (P=0.374) did not show a statistically significant difference between the two groups. There was no significant difference in the visual outcomes (P>0.05). Conclusion: Cyclosporine 0.05% was superior to artificial tears in improving tear stability after cataract surgery in the management of immediate postoperative dry eye. It may provide a more effective therapeutic option for the management of dry eye symptoms in the clinical setting.

Correlation between serum cytokine levels and the effect of allogeneic serum-based eye drops.

INTRODUCTION: The Institute of Hematology and Transfusion Medicine (IHTM) in Warsaw has produced autologous serum eye drops (ASEDs) for the treatment of Dry Eye Syndrome (DES) since 1991. In 2019, IHTM introduced allogeneic tears (alloSEDs) for patients on long-term treatment. MATERIALS AND METHODS: 114 patients who applied alloSEDs were included in the study.They were asked to complete the OSDI questionnaire before and after using ASEDs and 100 units of alloSEDs drops from each donation. The OSDI index rates DES severity (0 no symptoms; 100 severe). We also compared the content of IL-1ß, IL-2, IL- 6, IL-10 and VEGF in ASEDs (38 samples) and alloSEDs (15 serum samples). The study data covered the 2019-2022 period. RESULTS: 114 patients participated in the study. We compared the the effectiveness of ASEDs and alloSEDs. The average, OSDI dropped from 68.42 ± 5,86 (before application) to 51.05 ± 19,06 (after application). Data from the questionnaires (prepared at IHTM) completed and returned (41/114) present the most common indications for the use of serum drops, including DES with no underlying disease, DES secondary to GvHD (Graft versus Host Disease), Sjögren's Syndrome (SS). The study reported higher cytokine levels associated with disease entities such as SS. After application of drops with high cytokine levels, patients reported adverse reactions such as sand under the eyelids, impaired visual acuity, and worse eye lubrication. CONCLUSIONS: AlloSEDs with acceptably low values of pro-inflammatory cytokines and sufficiently high levels of VEGF growth factor may contribute to alleviation of inflammatory eye symptoms.

Peripheral hypertrophic subepithelial corneal opacification - Role of tear secretion, medication and systemic diseases.

BACKGROUND: Peripheral hypertrophic subepithelial corneal opacification (PHSCO) is a corneal disease that may severely affect vision. The major goal of this study was to test the hypothesis that tear secretion, medication and systemic diseases are associated with PHSCO. METHODS: This is a retrospective, case-control study conducted at the Department of Ophthalmology, University Medical Center of the Johannes Gutenberg University Mainz. We analysed medical records of patients diagnosed with PHSCO. Sex, age, Schirmer's test II, general medication and medical history were assessed and compared to an age- and sex-matched control group from the Gutenberg Health Study (GHS). RESULTS: One hundred ninety-five eyes of 112 patients with PHSCO were included. Eighty-eight patients were female with a mean age of 55.3 ± 14.7 years (23-89 years) and 24 patients were male with a mean age of 59.3 ± 12.6 years (38-84 years). In 83 patients (74.1%) both eyes were involved. The Schirmer's test II was significantly reduced in patients with PHSCO compared to the GHS control group (p < 0.001). Patients with PHSCO were more frequently administered artificial tears and steroid eye drops (p < 0.001) and were more hyperopic than healthy controls (p = 0.01). Systemic diseases or medication did not differ markedly between PHSCO and healthy controls. CONCLUSION: Reduced tear secretion and more frequent use of artificial tears in patients with PHSCO suggest a link between PHSCO and dry eye disease. The results of the study do not support our hypothesis that PHSCO is associated with systemic diseases. Interestingly, patients with PHSCO were less frequently on ß-blockers than control subjects.

New advances in medical management of dry eye: optimizing treatment strategies for enhanced relief.

PURPOSE: Dry eye disease (DED) is a prevalent ocular surface disease that is conventionally characterized by tear film hyperosmolarity and instability. This review presents a summarized classification of DED, followed by a comprehensive discussion of the most recent topical and systemic medications and clinical recommendations for selecting the most appropriate option for each patient. METHODS: An extensive literature search was conducted on electronic databases, such as PubMed, Scopus, and Web of Science, using keywords including "dry eye syndrome," "ocular surface disease," "medical management," "artificial tears," "topical immunomodulators," and "meibomian gland dysfunction." RESULTS: The underlying reasons for DED can range from insufficient aqueous tear production to increased tear evaporation. Recent literature has provided a more in-depth understanding of the pathophysiology of DED by examining the tear film's lipid, aqueous, and mucin layers. However, despite these advancements, medical management of patients with symptomatic DED has not fully reflected this modernized knowledge of its pathophysiology. CONCLUSION: To develop a rationalized strategy for treating DED, it is crucial to have updated knowledge of therapeutic options, their mechanisms of actions, and indications based on the DED type and underlying causes.

Extensively Drug-Resistant Pseudomonas aeruginosa Outbreak Associated With Artificial Tears.

BACKGROUND: Carbapenemase-producing, carbapenem-resistant Pseudomonas aeruginosa (CP-CRPA) are extensively drug-resistant bacteria. We investigated the source of a multistate CP-CRPA outbreak. METHODS: Cases were defined as a US patient's first isolation of P. aeruginosa sequence type 1203 with carbapenemase gene blaVIM-80 and cephalosporinase gene blaGES-9 from any specimen source collected and reported to the Centers for Disease Control and Prevention during 1 January 2022-15 May 2023. We conducted a 1:1 matched case-control study at the post-acute care facility with the most cases, assessed exposures associated with case status for all case-patients, and tested products for bacterial contamination. RESULTS: We identified 81 case-patients from 18 states, 27 of whom were identified through surveillance cultures. Four (7%) of 54 case-patients with clinical cultures died within 30 days of culture collection, and 4 (22%) of 18 with eye infections underwent enucleation. In the case-control study, case-patients had increased odds of receiving artificial tears versus controls (crude matched OR, 5.0; 95% CI, 1.1-22.8). Overall, artificial tears use was reported by 61 (87%) of 70 case-patients with information; 43 (77%) of 56 case-patients with brand information reported use of Brand A, an imported, preservative-free, over-the-counter (OTC) product. Bacteria isolated from opened and unopened bottles of Brand A were genetically related to patient isolates. Food and Drug Administration inspection of the manufacturing plant identified likely sources of contamination. CONCLUSIONS: A manufactured medical product serving as the vehicle for carbapenemase-producing organisms is unprecedented in the United States. The clinical impacts from this outbreak underscore the need for improved requirements for US OTC product importers.

Dissociation Kinetics and Antimicrobial Activity of Ofloxacin Antibiotic in Artificial Tears Via 1H-NMR, Raman, and UV-Vis Spectroscopic Analysis.

Introduction: The hydrogen-bonded networks play a significant role in influencing several physicochemical properties of ofloxacin in artificial tears (ATs), including density, pH, viscosity, and self-diffusion coefficients. The activities of the ofloxacin antibiotic with Ats mixtures are not solely determined by their concentration but are also influenced by the strength of the hydrogen bonding network which highlight the importance of considering factors such as excessive tear production and dry eye conditions when formulating appropriate dosages of ofloxacin antibiotics for eye drops. Objectives: Investigating the physicochemical properties of ofloxacin-ATs mixtures, which serve as a model for understanding the impact of hydrogen bonding on the antimicrobial activity of ofloxacin antibiotic eye drops. Determine the antimicrobial activities of the ofloxacin-Ats mixture with different concentration of ofloxacin. Methods: The ofloxacin-ATs mixtures were analyzed using 1H-NMR, Raman, and UV-Vis spectroscopies, with variation of ofloxacin concentration to study its dissociation kinetics in ATs, mimicking its behavior in human eye tears. The investigation includes comprehensive analysis of 1H-NMR spectral data, self-diffusion coefficients, Raman spectroscopy, UV-Vis spectroscopy, liquid viscosity, and acidity, providing a comprehensive assessment of the physicochemical properties. Results: Analysis of NMR chemical shifts, linewidths, and self-diffusion coefficient curves reveals distinct patterns, with peaks or minima observed around 0.6 ofloxacin mole fraction dissociated in ATs, indicating a strong correlation with the hydrogen bonding network. Additionally, the pH data exhibits a similar trend to viscosity, suggesting an influence of the hydrogen bonding network on protonic ion concentrations. Antibacterial activity of the ofloxacin-ATs mixtures is evaluated through growth rate analysis against Salmonella typhimurium, considering varying concentrations with mole fractions of 0.1, 0.4, 0.6, 0.8, and 0.9. Conclusions: The antibiotic-ATs mixture with a mole fraction of 0.6 ofloxacin exhibited lower activity compared to mixtures with mole fractions of 0.1 and 0.4, despite its lower concentration. The activities of the mixtures are not solely dependent on concentration but are also influenced by the strength of the hydrogen bonding network. These findings emphasize the importance of considering tear over-secretion and dry eye problems when designing appropriate doses of ofloxacin antibiotics for eye drop formulations.

Two Artificial Tears Outbreak-Associated Cases of Extensively Drug-Resistant Pseudomonas aeruginosa Detected Through Whole Genome Sequencing-Based Surveillance.

We describe 2 cases of extensively drug-resistant Pseudomonas aeruginosa infection caused by a strain of public health concern, as it was recently associated with a nationwide outbreak of contaminated artificial tears. Both cases were detected through database review of genomes in the Enhanced Detection System for Hospital-Associated Transmission (EDS-HAT), a routine genome sequencing-based surveillance program. We generated a high-quality reference genome for the outbreak strain from an isolate from our center and examined the mobile elements encoding blaVIM-80 and bla-GES-9 carbapenemases. We used publicly available Pseudomonas aeruginosa genomes to explore the genetic relatedness and antimicrobial resistance genes of the outbreak strain.

Multi-symptom Relief with Propylene Glycol-Hydroxypropyl-Guar Nanoemulsion Lubricant Eye Drops in Subjects with Dry Eye Disease: A Post-Marketing Prospective Study.

INTRODUCTION: The study aimed to evaluate multi-symptom relief of dry eye manifestations with the use of propylene glycol-hydroxypropyl-guar (PG-HPG) nanoemulsion lubricant eye drops, among subjects with dry eye disease (DED). METHODS: This was a post-marketing, prospective, single-arm study conducted in the USA. Subjects aged ≥ 18 years, with tear breakup time (TBUT) ≤ 10 s for both eyes, dry eye questionnaire-5 (DEQ-5) "watery eyes" symptom score 1-4, symptoms of burning/stinging, sore and tired eyes as determined by impact of dry eye on everyday living-symptom bother (IDEEL-SB) questionnaire, and IDEEL-SB score 16-65 were included. Subjects were required to complete IDEEL-SB and DEQ-5 at days 0, 14 ± 2, and 28 ± 2, and self-administer one drop of PG-HPG four times daily for 28 ± 2 days. Primary endpoints were change from baseline at day 28 in symptoms of sore, stinging/burning, and tired eyes on IDEEL-SB; and symptom of watery eyes on DEQ-5. Other endpoints evaluated were corneal staining and TBUT at baseline and day 28 ± 2; symptom relief (5-point Likert scale) at day 28 ± 2, and safety. RESULTS: Of 119 subjects enrolled, 95 completed the study (mean ± SD age 61.2 ± 13.0 years; female 69.5%). Mean IDEEL-SB scores reduced significantly from baseline at day 28 for symptoms of aching/sore eyes (change from baseline - 1.0 ± 1.1), burning/stinging eyes (change from baseline - 1.1 ± 0.9), and tired eyes (change from baseline - 1.1 ± 1.0) (all p < 0.0001). Mean DEQ-5 score for watery eye symptoms significantly reduced from baseline at day 28 (change from baseline - 0.9 ± 1.0, p < 0.0001). Corneal staining at day 28 was comparable to baseline. TBUT improved from baseline to day 28. On a Likert scale, more than 50% of subjects reported relief from symptoms of sore, stinging, and burning eyes. Three (3.1%) subjects reported treatment-emergent adverse events (non-ocular). CONCLUSIONS: PG-HPG nanoemulsion lubricant eye drops significantly improved multiple dry eye symptoms in subjects with DED over 28 days, with no new safety concerns. TRIAL REGISTRATION: ClinicalTrials.gov Identifier, NCT05056155.

Comparison of Two Topical Lubricants on the Corneal Surface Recovery and Patient Discomfort After Photorefractive Keratectomy.

INTRODUCTION: This study aimed to compare the effect of two preservative-free (PF) artificial tears, one containing carboxymethylcellulose (CMC) (control group) vs another containing hyaluronic acid and hydroxypropyl guar (HA + HP-guar) (study group), on the healing of the corneal epithelium and the ocular discomfort after bilateral photorefractive keratectomy (PRK) surgery. METHODS: A total of 68 patients that were scheduled to have PRK to correct myopia were randomized into two groups: 34 patients (68 eyes) in the study group and 34 patients (68 eyes) in the control group. Ocular examinations were performed on postoperative days 1, 4, 7, 30, and 90, evaluating the diameter of the de-epithelized cornea, the fluorescein staining using the Oxford scale, the tear film osmolarity and stability (tear breakup time), and the pain using visual analog scale (VAS). RESULTS: On postoperative day 4, 97% of the study eyes vs 84.4% of the control eyes were completely re-epithelized (p = 0.01). Less ocular pain was observed on postoperative day 3 in the study group (5.0 (3.0-6.0) vs 6.0 (3.5-7.0), p = 0.03). No differences were observed beyond postoperative day 7 in the healing of the corneal epithelium, non-invasive Keratograph breakup time (NIKBUT), and the self-perceived ocular discomfort between the two groups. CONCLUSION: The current study shows faster healing of the corneal epithelium and less ocular pain and discomfort in the first days after PRK with the use of topical lubricants containing HA + HP-guar compared to conventional CMC artificial tears, probably due to the different trophic effect of the aforementioned tears on the corneal epithelial cells. TRIAL REGISTRATION: EudraCT No. 2020-003488-25.

A comparison between hyaluronic acid and other single ingredient eye drops for dry eye, a review.

Dry eye disease (DED) is a highly prevalent and debilitating condition. Hyaluronic acid (HA) is a naturally occurring glycosaminoglycan that has a long history as a safe and effective DED treatment. HA is frequently used as a comparator when assessing other topical DED treatments. This study aims to summarise and critically evaluate the literature describing all isolated active ingredients that have been directly compared with HA in the treatment of DED. A literature search was conducted in Embase using Ovid on the 24th of August 2021 and in PubMed including MEDLINE on the 20th of September 2021. Twenty-three studies met the inclusion criteria, 21 of which were randomised controlled trials. Seventeen different ingredients representing six treatment categories were compared with HA treatment. Most measures showed no significant difference between treatments, suggesting either equivalency of treatments or that studies were underpowered. Only two ingredients were represented in more than two studies; carboxymethyl cellulose treatment appears equivalent to HA treatment, while Diquafosol treatment appears superior to HA treatment. Drop-frequency varied from one to eight drops daily. No single study explained the choice of drop frequency. Nine studies used a HA concentration of 0.1% which may be below therapeutic levels. Nine studies reported using preserved formulations, six of them with differences in preservatives between the compared groups. Thirteen studies were financially linked to industry. No major complications were reported. Studies were not designed to find differences in treatment effects for different types or severities of DED. HA is a good comparator treatment when assessing other DED treatments, although consensus after decades of use is still lacking for best choice of concentration, molecular weight and drop tonicity. Well-designed studies are needed to determine an evidence-based standard for HA treatment to be used as comparator.

Assessing the Effects of 0.3% Carboxymethylcellulose Tear Substitute Treatment on Symptoms and Signs of Dry Eye Disease in Elderly Population: A Prospective Longitudinal Study.

BACKGROUND: We aimed to evaluate the effects of 0.3% carboxymethylcellulose (CMC) tear substitute treatment in dry eye disease (DED), as well as treatment compliance and adverse events (AEs). METHODS: In this prospective, longitudinal study, a total of 30 eyes receiving 0.3% CMC tear substitute four times daily for DED were evaluated. Clinical endpoints included an ocular surface disease index (OSDI) questionnaire, average non-invasive tear film break-up time (A-NIBUT), lipid layer thickness (LLT), and a Schirmer test with anesthesia (ST). Treatment compliance and AEs were also assessed. All evaluations were performed at 2, 4, and 12 weeks of follow-up. RESULTS: At the end of the follow-up, significant improvement was observed in all clinical endpoints with the following mean values: ΔOSDI questionnaire of -22.53 ± 14.68 points, ΔA-NIBUT of 4.81 ± 2.88 s, ΔLLT of 5.63 ± 6.53 nm, and ΔST of 2.8 ± 2.1 mm (p < 0.001 for all comparisons). Although repeated measures analysis showed that all clinical endpoints presented statistically significant differences (p < 0.001 for all comparisons LLTBaseline-LLT2-weeks (p = 0.460) and LLT4-weeks-LLT12-weeks (p = 0.071) were the only pairs of measures that reported non-statistically significant differences). In addition, treatment compliance was 94.3 ± 5.2% and transient AEs related to the use of 0.3% CMC tear substitute were reported. CONCLUSIONS: 0.3% CMC tear substitute treatment seems to achieve beneficial effects on the OSDI questionnaire, A-NIBUT, LLT, and ST. However, further studies at this concentration are needed to confirm these results.

Safe and Effective Management of Dry Eye Symptoms with Hydroxypropyl Guar and Hyaluronic Acid Dual-Polymer Lubricating Eye Drops: A Review of Preclinical and Clinical Studies.

Dry eye disease (DED) is a chronic ocular surface disorder often characterized by decreased tear production and rapid tear evaporation that affect tear film stability and homeostasis. The common symptoms of DED include ocular discomfort, visual disturbances, dryness, and itching. Artificial tears are the mainstay of DED management and supplement one or more layers of the tear film. Artificial tear drops are available as a combination of viscosity-enhancing agents (demulcents/lubricants), humectants, and buffers either with or without preservatives. Artificial tears, as a combination of components (polymers/demulcents/viscosity-enhancing agents), can provide synergistic action compared with a single component for the management of multifactorial signs and symptoms of DED. This review describes the formulation components, physicochemical properties, mechanism of action, and summary of preclinical and clinical evidence on the hydroxypropyl guar-hyaluronic acid (HPG-HA) dual-polymer lubricant eye drops (SYSTANE™ HYDRATION). The dual-polymer eye drops consist of dual demulcents (propylene glycol and polyethylene glycol 400) and the polymers hydroxypropyl guar (HPG) and hyaluronic acid (HA). When instilled on the ocular surface, HPG forms a cross-linked gel matrix with borate ions that prolongs the retention of demulcents, thus providing long-lasting lubrication and ocular surface protection. Additionally, HA stabilizes the tear film, increases corneal wettability, and reduces friction during blinks due to its hygroscopic and viscoelastic properties. Preclinical evidence demonstrates that HPG HA dual-polymer lubricant eye drops provide protection against desiccation by cell hydration and surface retention, cell barrier protection, prolonged lubrication, and promotion of corneal re-epithelialization. Clinical scientific evidence demonstrates that HPG HA dual-polymer lubricant eye drops are safe and effective in the management of DED. Specifically, they reduce the signs and symptoms of DED, reduce dry eye symptoms post-cataract surgery, and improve tear film quality in healthy eyes.

Randomized controlled trial on the efficacy and safety of autologous serum eye drops in dry eye syndrome.

BACKGROUND: Autologous serum eye drops (ASEDs), a novel treatment derived from blood serum, have emerged as a groundbreaking solution for managing dry eye syndrome (DES). These drops have shown significant promise in relieving the distressing symptoms of DES. This study aimed to evaluate the safety and effectiveness of ASEDs compared to traditional treatments, which often prove inadequate or result in unwanted side effects, particularly in individuals with moderate-to-severe DES. AIM: To evaluate whether ASEDs are safer and more effective than conventional artificial tears in the treatment of moderate-to-severe DES. METHODS: This multi-centered randomized controlled trial included 240 patients with moderate-to-severe DES from three ophthalmology clinics in China. They were randomly assigned to receive either ASEDs or artificial tears for 12 wk. The primary outcome was the change in the ocular surface disease index (OSDI) score, with secondary outcomes including tear break-up time (TBUT), Schirmer I test, corneal fluorescein staining (CFS), and conjunctival impression cytology (CIC). Statistics analysis was performed using an analysis of covariance with adjustments made for baseline values. RESULTS: Our findings revealed that both ASEDs and artificial tears significantly improved the OSDI score, TBUT, Schirmer I test, CFS, and CIC from baseline to week 12. The ASEDs group showed significantly greater improvement in all these measures than the artificial tears group (all P values < 0.05). The average difference in the OSDI score between the two cohorts was -10.3 (95% confidence interval: -13.6 to -7.0), indicating a substantial improvement in the ASEDs group. The occurrence of adverse events was comparable between cohorts, with no reports of severe adverse events. CONCLUSION: ASEDs are more effective and safer than artificial tears for mitigating symptoms of moderate-to-severe DES. ASEDs could be an alternative/supplementary therapy for patients with DES less responsive to traditional treatments.

Tear Film Stabilization and Symptom Improvement in Dry Eye Disease: The Role of Hyaluronic Acid and Trehalose Eyedrops versus Carmellose Sodium.

This study evaluated the effectiveness of hyaluronic acid and trehalose (HA/trehalose) eyedrops in managing dry eye disease (DED) symptoms by measuring tear stability and administering a DED questionnaire. Sixty patients were treated with either HA/trehalose eyedrops (Tear A) or carmellose sodium eyedrops (Tear B) as controls. The tear breakup time (TBUT) and non-invasive breakup time (NIBUT) were monitored, and patients completed the standard patient evaluation of eye dryness (SPEED) questionnaire. After two months of twice-daily applications, patients treated with the HA/trehalose eyedrops demonstrated significant improvements in the NIBUT (12.98 ± 3.22 s) and TBUT (12.95 ± 2.98 s), indicating increased tear stability. Moreover, they reported lower dry eye sensation (6.70 ± 4.94 SPEED score points), suggesting a reduction in DED symptoms. These findings underscore the efficacy of HA/trehalose eyedrops in improving both the objective and subjective signs of DED, with twice-daily application enhancing ocular surface conditions and reducing patient-reported symptoms.