Study of a New Preservative-free Eye Drop Combining Trehalose, Sodium Hyaluronate, and NAAGA for Treating Dry Eye Disease

What this Trial Is About

Researchers are evaluating a new preservative-free combination of trehalose, sodium hyaluronate, and N-acetyl-aspartyl-glutamate NAAGA for treating dry eye disease DED. This prospective, non-randomized, non-comparative study aims to assess the performance and safety of this treatment at 3 and 6 months in 30 patients with DED. The study also examines patient compliance and the occurrence of dry eye flares over the treatment period. Participants will use the study device, referred to as T2769, daily throughout the study. The main study period lasts 6 months, during which patients will be monitored at baseline, 3 months, and 6 months. During these visits, researchers will assess symptoms and signs of dry eye disease to evaluate the treatments effect. Participants will complete self-questionnaires regularly to track symptoms and report any dry eye flare-ups. The primary outcome is the change in the Ocular Surface Disease Index OSDI score from baseline to 6 months. Safety, performance, and patient compliance will be closely monitored throughout the study. The total duration of participation is 6 months.

New Preservative-free Combination of Trehalose, Sodium Hyaluronate and N-acetyl-aspartyl-glutamate (NAAGA) in Dry Eye