{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T08:20:30Z","timestamp":1789633230146,"version":"build-2803163510"},"reference-count":26,"publisher":"MDPI AG","issue":"23","license":[{"start":{"date-parts":[[2022,11,26]],"date-time":"2022-11-26T00:00:00Z","timestamp":1669420800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>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\u00ae Off Health Italia, Firenze, Italy) (CXHAL) versus trehalose 3% (Thealoz\u00ae, 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 \u00b1 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\u00ae; 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.<\/jats:p>","DOI":"10.3390\/jcm11236975","type":"journal-article","created":{"date-parts":[[2022,11,28]],"date-time":"2022-11-28T06:04:36Z","timestamp":1669615476000},"page":"6975","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["Clinical Efficacy, Tolerability and Safety of a New Multiple-Action Eyedrop in Subjects with Moderate to Severe Dry Eye"],"prefix":"10.3390","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8083-3437","authenticated-orcid":false,"given":"Anna Maria","family":"Roszkowska","sequence":"first","affiliation":[{"name":"Ophthalmology Clinic, Department of Biomedical Sciences, University Hospital of Messina, 98122 Messina, Italy"},{"name":"Ophthalmology Department, Faculty of Medicine and Health Sciences, Andrzej Frycz Modrzewski Krakow University, 30-705 Krakow, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2854-4141","authenticated-orcid":false,"given":"Leandro","family":"Inferrera","sequence":"additional","affiliation":[{"name":"Ophthalmology Clinic, Department of Biomedical Sciences, University Hospital of Messina, 98122 Messina, Italy"},{"name":"Eye Clinic, Department of Medical, Surgical Sciences and Health, University of Trieste, 34127 Trieste, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rosaria","family":"Spinella","sequence":"additional","affiliation":[{"name":"Ophthalmology Clinic, Department of Biomedical Sciences, University Hospital of Messina, 98122 Messina, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisa Imelde","family":"Postorino","sequence":"additional","affiliation":[{"name":"Ophthalmology Clinic, Department of Biomedical Sciences, University Hospital of Messina, 98122 Messina, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Romana","family":"Gargano","sequence":"additional","affiliation":[{"name":"Department of Economics, University of Messina, 98122 Messina, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giovanni Wiliam","family":"Oliverio","sequence":"additional","affiliation":[{"name":"Ophthalmology Clinic, Department of Biomedical Sciences, University Hospital of Messina, 98122 Messina, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9582-9799","authenticated-orcid":false,"given":"Pasquale","family":"Aragona","sequence":"additional","affiliation":[{"name":"Ophthalmology Clinic, Department of Biomedical Sciences, University Hospital of Messina, 98122 Messina, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2022,11,26]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"2212","DOI":"10.1056\/NEJMra1407936","article-title":"Dry Eye","volume":"378","author":"Clayton","year":"2018","journal-title":"N. 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