Evaluation of a new artificial tear formulation for the management of tear film stability and visual function in patients with dry eye

Gail Torkildsen,1 Mile Brujic,2 Michael S Cooper,3 Paul Karpecki,4 Parag Majmudar,5 William Trattler,6 Meryl Reis,7 Joseph B Ciolino1,8 1Andover Eye Clinic, Andover MA, 2Premier Vision Group, Bowling Green, OH, 3Windam Eye Group, Willimantic, CT, 4Gaddie Eye Center, Louisville KY, 5Chicago Cornea Consultants, Chicago IL, 6Center For Excellence in Eye Care, Miami, FL, 7Rohto Mentholatum Research Laboratories, Horsham, PA, 8Massachusetts Eye and Ear Infirmary, Boston MA, USA Purpose: Artificial tears are the first line of therapy for dry eye disease (DED) and are also the most frequently used treatment approach for this common condition. Despite this, there are few published studies that directly compare the effectiveness of different drop preparations, especially those formulated specifically for dry eye. In this study, we tested a new artificial tear product, Rohto® Dry-Aid™, for its ability to relieve the signs and symptoms of DED. The study used a second drop, Systane® Ultra, as a positive comparator.Materials and methods: This was a prospective, single-center, open-label, parallel-group study comparing the effects of the two products when used continuously over ~30 days (Clinical Trials registration number NCT03183089). Subjects were randomly assigned to one of the two test groups and were monitored 2 and 4 weeks after enrollment. Efficacy endpoints included ocular staining, visual function, and ocular discomfort.Results: Treatment groups had similar ocular staining and ocular comfort scores, and both showed statistically significant ocular discomfort score improvement. Subjects in the Rohto group reported significant improvements in visual tasking activities such as watching television and driving at night. There was also a tendency for diary symptom scores to worsen from morning to evening in the Systane group, but not in the Rohto group; this trend was not significant, but warrants further study.Conclusion: The two products, Rohto Dry-Aid and Systane Ultra, elicited comparable effects on the signs and symptoms of DED. While both products are designed to provide long-lasting relief, subjects in the Rohto group experienced a superior relief from discomfort associated with visual tasking activities and daily diaries, indicating that the Rohto drops may provide a longer duration of symptomatic relief over the course of the day. Keywords: artificial tears, dry eye, ocular surface, visual tasking, blurred visio

Lifitegrast Ophthalmic Solution 5.0% versus Placebo for Treatment of Dry Eye Disease: Results of the Randomized Phase III OPUS-2 Study

PURPOSE: Lifitegrast is an integrin antagonist that decreases T-cell-mediated inflammation associated with dry eye disease (DED). We report the results of OPUS-2, a phase III study evaluating the efficacy and safety of lifitegrast compared with placebo for the treatment of DED. DESIGN: A 12-week, multicenter, randomized, prospective, double-masked, placebo-controlled clinical trial. PARTICIPANTS: Adults aged \u3e/=18 years with use of artificial tears within 30 days, inferior corneal staining score \u3e/=0.5 (0-4 scale), Schirmer tear test (without anesthesia) \u3e/=1 and/=40 (0-100 visual analogue scale [VAS]). METHODS: Subjects were randomized 1:1 after 14-day placebo run-in to lifitegrast ophthalmic solution 5.0% or placebo twice daily for 84 days. MAIN OUTCOME MEASURES: Co-primary efficacy end points were change, from baseline to day 84, in eye dryness score (VAS, both eyes) and inferior corneal fluorescein staining score in the designated study eye. Secondary end points were change, from baseline to day 84, in ocular discomfort score (0-4 scale) in study eye, eye discomfort score (VAS), total corneal staining score in the study eye, and nasal conjunctival lissamine green staining score (0-4 scale) in the study eye. Treatment-emergent adverse events (TEAEs) were recorded. RESULTS: A total of 718 subjects were randomized: placebo, n = 360; lifitegrast, n = 358 (intent-to-treat population). Lifitegrast-treated subjects experienced greater improvement in eye dryness than placebo-treated subjects (treatment effect, 12.61; 95% confidence interval [CI], 8.51-16.70; P \u3c 0.0001). There was no between-group difference in inferior corneal staining (treatment effect, 0.03; 95% CI, -0.10 to 0.17; P = 0.6186). There was nominally significant improvement of secondary symptom end points among lifitegrast-treated subjects: ocular discomfort (nominal P = 0.0005) and eye discomfort (nominal, P \u3c 0.0001). There were no between-group differences on secondary signs: total corneal staining and nasal lissamine staining. More lifitegrast-treated subjects (33.7%) than placebo-treated subjects (16.4%) experienced ocular TEAEs; no ocular TEAEs were serious. CONCLUSIONS: Lifitegrast met the co-primary symptom end point (eye dryness) but not the co-primary sign end point (inferior corneal staining). Secondary end point findings were consistent with this pattern. Most ocular TEAEs were mild to moderate; there were no unexpected TEAEs. Lifitegrast warrants further consideration as a treatment for DED

THERAPEUTIC POTENTIAL OF „DERIVED-MULTIPLE ALLOGENEIC PROTEINS PARACRINE SIGNALING-D-MAPPS” IN THE TREATMENT OF DRY EYE DISEASE

The primary aim of this retrospective study was to estimate significance of determining C-reactive protein and procalcitonin for a diagnosis of sepsis in adult patients in early triage. Also, the aim of this study was to measure the sensitivity of the SIRS criteria, PCT and CRP levels and sepsis definitions to identify the most serious sepsis cases in the prehospital setting and at the Emer-gency Department (ED) triage. All patients were divided into two groups according to specific criteria for defining sepsis. First group (SIRS+ group) of patients were patients with clinically and/or laboratory confirmed sepsis (or systemic inflammatory response syndrome (SIRS) to bacterial infection with different local-ization). For confirmation of the SIRS we consider positive two or more clinical criteria (≥2 clinical criteria). The SIRS criteria use the clinical criteria of the Surviving Sepsis Campaign (SSC) for the SIRS, comprising at least two of the following criteria: HR > 90/min, RR > 20/min and temperature 15x109/L, leu-copenia 10% immature leucocytes. Second group of patients were patients with the SIRS negative criteria as a diagnostic tool (SIRS-group). We have founded that the CRP showed high sensitivity but no specificity in patients with sepsis, but on the other side, the PCT as a diagnostic marker showed a high sensitivity and high specificity in these patients. Also, the PCT is in positive correlation with the SIRS criteria, which could be of a clinical significance in early diagnosis of septic infections

TFOS DEWS II Diagnostic Methodology report

The role of the Tear Film and Ocular Surface Society (TFOS) Dry Eye Workshop (DEWS) II Diagnostic Methodology Subcommittee was 1) to identify tests used to diagnose and monitor dry eye disease (DED), 2) to identify those most appropriate to fulfil the definition of DED and its sub-classifications, 3) to propose the most appropriate order and technique to conduct these tests in a clinical setting, and 4) to provide a differential diagnosis for DED and distinguish conditions where DED is a comorbidity. Prior to diagnosis, it is important to exclude conditions that can mimic DED with the aid of triaging questions. Symptom screening with the DEQ-5 or OSDI confirms that a patient might have DED and triggers the conduct of diagnostic tests of (ideally non-invasive) breakup time, osmolarity and ocular surface staining with fluorescein and lissamine green (observing the cornea, conjunctiva and eyelid margin). Meibomian gland dysfunction, lipid thickness/dynamics and tear volume assessment and their severity allow sub-classification of DED (as predominantly evaporative or aqueous deficient) which informs the management of DED. Videos of these diagnostic and sub-classification techniques are available on the TFOS website. It is envisaged that the identification of the key tests to diagnose and monitor DED and its sub-classifications will inform future epidemiological studies and management clinical trials, improving comparability, and enabling identification of the sub-classification of DED in which different management strategies are most efficacious