Vision (Basel). 2025 Dec 22;10(1):1. doi: 10.3390/vision10010001. ABSTRACT The aim of this study was to evaluate the performance and safety of T2769 (Thealoz ® Total), a preservative-free eye drop combining 0.15% sodium hyaluronate, 3% trehalose, and 2.45% N-acetylaspartyl-gluta…
Vision (Basel). 2025 Dec 22;10(1):1. doi: 10.3390/vision10010001.
ABSTRACT
The aim of this study was to evaluate the performance and safety of T2769 (Thealoz® Total), a preservative-free eye drop combining 0.15% sodium hyaluronate, 3% trehalose, and 2.45% N-acetylaspartyl-glutamate (NAAGA), in contact lens wearers with dry eye symptoms and discomfort. This prospective, single-arm investigation enrolled 34 adult contact lens wearers with Ocular Surface Disease Index (OSDI) scores ≥ 18 and Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) scores ≥ 12. Patients instilled one drop of T2769 three to six times daily for 36 days. Performance assessments included CLDEQ-8, ocular discomfort and symptoms, OSDI, soothing sensation, and ocular signs. Safety assessments included adverse events (AEs), far BCVA, and ocular tolerance. CLDEQ-8 improved from the baseline at Day 36 (-12.6 ± 5.0; p < 0.001) and as early as D15, with similar improvements in ocular discomfort, OSDI, and total symptom score. Soothing sensation was judged important by 79.4% of patients at D36. Ocular surface staining, tear break-up time, and the Schirmer test improved at D15 and D36, while conjunctival hyperaemia improved in 82.4% of patients at D36. Two non-serious treatment-related AEs (photophobia and blurred vision) occurred in one patient. BCVA was unchanged, and tolerance was rated very satisfactory/satisfactory. In conclusion, T2769 was safe and effective for reducing contact lens-associated dry eyes and discomfort.
PMID:41562956 | PMC:PMC12821722 | DOI:10.3390/vision10010001