Purpose: To evaluate the clinical efficacy and safety of propylene glycol/hydroxypropyl-guar (PG-HPG)-based nanoemulsion (Systane^® Complete) lubricant eye drops in participants with dry eye disease (DED). Participants and Methods: In this phase IV, open-label, single-arm, interventional, multicenter study, adult participants with DED – subtyped into aqueous deficient, evaporative, and mixed dry eye – were instructed to instill one drop of PG-HPG in each eye twice a day for 28 days. Endpoints included change from baseline in tear film break-up time (TFBUT) (primary) and ocular discomfort visual analog scale (VAS) score at Day 14 and TFBUT at Day 28 (secondary). Safety was assessed throughout the study. Data were analyzed for overall patient cohort and by DED subtypes. Results: A total of 134 participants received treatment (mean age: 56.6 years; female: 75.4%). At Day 14, the mean (standard deviation [SD]) TFBUT increased from 2.6 (1.00) seconds at baseline to 4.2 (2.92) seconds (mean change: 1.5 [2.80] seconds); median change was 0.8 seconds (95% CI: 0.52, 1.19) for the overall cohort; the change was maintained at Day 28 (mean change: 1.4 (2.80) seconds, median change: 0.8 seconds (95% CI: 0.49, 1.17). Subgroup analysis showed a mean change (SD) from baseline in TFBUT of 1.1 (2.41) seconds for aqueous deficient, 2.4 (3.17) seconds for evaporative, and 1.2 (2.63) seconds for mixed dry eye at Day 14, respectively. The ocular discomfort VAS score improved (decreased) from baseline at Day 14 (mean [SD] change: − 17.3 [24.80]) for the overall cohort, − 22.0 [21.73] for aqueous deficient, − 17.6 [24.17] for evaporative and − 13.1 [27.49] for mixed dry eye subgroups). Adverse events (AEs) were reported in 9 (6.7%) participants. No serious AEs were reported during the study. Conclusion: Our study findings demonstrated that PG-HPG-based nanoemulsion lubricant eye drops were effective and well tolerated in participants with DED and all of its subtypes.

Efficacy and safety of dual-polymer hydroxypropyl guar- and hyaluronic acid-containing lubricant eyedrops for the management of dry-eye disease: a randomized double-masked clinical study Marc Labetoulle,1 Stefanie Schmickler,2 David Galarreta,3 Daniel Böhringer,4 Abayomi Ogundele,5 Michel Guillon,6 Christophe Baudouin7,8 1Ophtalmologie, Hôpital Bicêtre, APHP, South Paris Université, Kremlin-Bicêtre, Paris, France; 2Augen-Zentrum-Nordwest Augenpraxis, Ahaus, Germany; 3Hospital Clinico Universitario de Valladolid, Valladolid, Spain; 4Eye Center, University Hospital Freiburg, Freiburg, Germany; 5Novartis Pharmaceutical Corporation, Fort Worth, TX, USA; 6Ocular Technology Group, London, UK; 7Quinze-Vingts Hospital, DHU Sight Restore, University Versailles Saint Quentin en Yvelines, INSERM-DHOS CIC, Paris, France; 8Sorbonne Universités, UPMC Univ Paris 06, INSERM, CNRS, Institut de la Vision, Paris, France Background: An artificial-tear formulation containing the dual polymers hydroxypropyl guar (HPG) and hyaluronic acid (HA) is approved for the treatment of dry-eye disease (DED). The present study compared the efficacy and safety of the HPG-HA dual-polymer formulation vs a sodium hyaluronate (SH)-containing artificial-tear formulation in patients with DED.Methods: In a prospective, 6-week, multicenter, double-masked, parallel-group study, patients with DED aged ≥18 years and total ocular surface staining (TOSS) score ≥4 and ≤9 were randomized (1:1) to receive either HPG-HA or SH four times a day for 42 days. Changes from baseline in TOSS (primary end point), impact of dry eye on everyday life (IDEEL) treatment-satisfaction scores (effectiveness and inconvenience), and tear-film breakup time (TFBUT) at day 42 were assessed using a fixed-sequence testing strategy. Noninferiority was assessed on the primary end point based on the upper limit of two-sided 95% CIs for mean treatment difference (HPG-HA or SH) <2 units.Results: In total, 99 patients were randomized (HPG-HA, n= 50; SH, n= 49). At day 42, the least square (LS) mean ± SE change from baseline in TOSS was -1.16±0.24 and -0.92±0.23 in the HPG-HA and SH groups, respectively, and the treatment difference was -0.24±0.33 (95% CI -0.90 to 0.42). Noninferiority was demonstrated as the upper limit of the 95% CI was <2 units. LS mean change from baseline at day 42 for HPG-HA vs SH was -3.18 (P=0.4817) in IDEEL treatment-effectiveness scores, -12.56 (P=0.0001) in treatment-inconvenience scores, and 0.30 seconds (P=0.5789) in TFBUT.Conclusion: The HPG-HA dual-polymer formulation was noninferior to the SH lubricant eyedrops for improvement in ocular surface staining in DED. HPG-HA did not show improvement over SH in IDEEL treatment-satisfaction scores. No new safety findings were reported. Keywords: dry-eye disease, dual polymer, artificial tears, hydroxypropyl guar, hyaluronic acid

Purpose: To evaluate symptom relief in patients with dry eye disease (DED) following a single drop of propylene glycol-hydroxypropyl guar (PG-HPG) nanoemulsion (Systane^® Complete) lubricant eye drops. Methods: This was a Phase IV, multicenter, open-label, interventional study in adult patients with DED of aqueous-deficient, evaporative, and mixed subtypes. Patients instilled one drop of PG-HPG in each eye at Day 1. Endpoints included change from baseline in dry eye symptom and soothing sensation scores on Day 1 at 0, 4, and 8 hours post-dose. Symptom scores were assessed on a 0– 10 scale (0=no symptoms; 10=worst imaginable symptom). Tolerability of the drop was assessed based on assessment score on Day 1 following instillation for overall cohort and by DED subtype. Results: A total of 134 patients received treatment (mean age: 56.6 years; female: 75.4%). Median changes from baseline at Day 1 in dry eye symptom scores were − 1.0 (95% confidence interval [CI]:-3.0,-1.0), − 2.0 (95% CI:-3.0,-2.0), and − 2.0 (95% CI:-2.0,-1.0) at 0, 4, and 8 hours respectively. Subgroup analysis showed a median change from baseline in dry eye symptom score of − 2 (95% CI:-3.0,-1.0) for aqueous-deficient and evaporative subtypes and − 1 (95% CI:-3.0,-1.0) for mixed subtype at 8 hours. Median soothing sensation scores were 3 at 0 and 4 hours and 3.5 at 8 hours, with a range of 0– 10. Median (range) tolerability assessment scores were 0 (0– 8) for burning sensation, stinging sensation, blurring, and 0 (0– 10) for foreign body sensation. Tolerability assessment scores by DED subtype confirmed that the majority of patients reported scores in the range of 0– 5 for all components and in all subgroups analyzed. Conclusion: Our study demonstrated that PG-HPG nanoemulsion provided instant/immediate and sustained symptom relief for 8 hours post-single application and was well tolerated in patients with DED, demonstrated by their responses on each of the assessment scales.

In old subjects, the effect on visual performance of the interaction between the spectral power distribution of street lamps and the different types of intraocular lenses (IOLs) is unknown. Contrast threshold (CT) and reaction time (RT) were analysed in off-axis vision at mesopic illumination conditions provided by high-pressure sodium and metal-halide lamps, using a Maxwellian view optical system. Four groups of subjects participated: 10 young subjects, 20 elderly subjects with cataracts and the same subjects after cataract surgery were divided into two groups, 10 subjects implanted with a blue light-filtering and 10 subjects with a non-blue light-filtering IOL (NBIOL). Age-related cataract impairs detection and reaction capabilities; tasks that are nevertheless improved after surgery. The type of lamp does not affect both tasks in the case of the blue light-filtering IOL group, but it does in the NBIOL group. When comparing the two lenses, no detrimental effect of the blue light filter is observed in both tasks. In conclusion, at representative night-driving conditions, the spectral power distribution of the street lamp does not have a clinically relevant effect on visual tasks such as CT and visual RT in pseudophakic subjects, regardless of the type of IOL implanted.

Background/Objectives: Infectious keratitis and eye injuries, despite being well-recognized ophthalmological diseases, continue to pose diagnostic and therapeutic challenges in clinical practice; therefore, this study was conducted to assess the salient features of care provided by Spanish ophthalmologists working in emergency and ocular surface consultations to patients presenting with keratitis and ocular trauma. Methods: Nationwide cross-sectional survey with the participation of 100 ophthalmologists, including 50 ophthalmologists in emergency care and 50 ocular surface specialists. The study questionnaire assessed diagnostic approaches, treatment strategies, and factors influencing therapeutic decision making. Results: The mean age of participants (51% women) was 37.9 years, with 10.2 years of professional activity. External eye examination, slit lamp examination, fluorescein staining, computed tomography (CT) in penetrating injuries, and microbiological cultures in corneal ulcers were rated as important diagnostic methods. Topical antibiotics were especially recommended for keratitis in general (mean 80.6%) and for contact lens-related keratitis (85.6%). The use of antiseptics was limited. Topical corticosteroids were most commonly selected for viral keratitis with stromal and endothelial involvement (between 24.3% and 50.4%); chlorhexidine (52.0%) and propamidine (26.8%) for Acanthamoeba keratitis; re-epithelizing compounds (20.4%) and artificial tears (29.1%) for actinic keratitis; and topical antifungals for fungal keratitis (77%). Conclusions: This study highlights a limited availability of some specific diagnostic methods and an extensive use of topical antibiotics in the management of keratitis and ocular surface injuries, with relatively limited use of antiseptics. Areas of improvement in therapeutic approach would be awareness of a potential overuse of topical antibiotics with the consequences of increase in antimicrobial resistance.