Interventional, Multi-center, Randomized, Controlled, Open Label Clinical Investigation Between the Topical Administration of a Tear Substitute Containing Ancillary Medicinal Substance and Hyaluronic Acid 0.3% FBV01 Versus Hyaluronic Acid 0.3% in Subjects in the Treatment From Moderate to Severe Dry Eye Syndrome

What this Trial Is About

Researchers are evaluating an ophthalmic solution containing an ancillary medicinal substance combined with hyaluronic acid 0.3% called FBV01 compared to hyaluronic acid 0.3% alone in adults aged 18 years and older who have moderate-to-severe dry eye syndrome. The study aims to determine if the combination solution is at least as effective in improving dry eye symptoms and is safe, well tolerated, and used properly by participants over the treatment period. Participants will be randomly assigned to one of two groups one using the FBV01 solution and the other using hyaluronic acid 0.3% alone. Each participant will apply one drop in both eyes four times daily every 4 1 hours for about 30 days. This is a multicenter, prospective, randomized, open-label, controlled study lasting approximately 12 months, including an enrollment period of about 11 months. During the study, participants will attend visits at baseline, within 15 2 days, and within 30 4 days after starting treatment for assessments of dry eye signs and symptoms, safety, tolerability, and treatment compliance. The main outcome is the Symptom Assessment in Dry Eye SANDE questionnaire. Additional evaluations include ocular discomfort, tear film stability, eye surface condition, visual function, intraocular pressure, slit-lamp exams, and monitoring correct use of the study devices.

Clinical Investigation Between the Topical Administration of a Tear Substitute With Ancillary Medicinal Substance and Hyaluronic Acid 0.3% (FBV_01) vs Hyaluronic Acid 0.3% in Subjects in the Treatment From Moderate to Severe DED