N-Acetyl-Aspartyl Glutamic Acid (NAAGA)-Based Eye Drops for Contact Lens Wearers with Dry Eye Symptoms and Discomfort.
Ioanna Misheva, Vesselin Daskalov, Dimitar Dzhelebov, Kalina Ilieva, Ralitsa Kermedchieva, Malina Topchiyska, Petar Yanev, Christina Grupcheva
Abstract
Open AccessThe 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.