Comparing BUFY02 and TRB02 Eye Drops for Treating Dry Eye Disease A Study to See If BUFY02 Works as Well and Is As Safe As TRB02

What this Trial Is About

Researchers are comparing two treatments, BUFY02 and TRB02, for people with dry eye disease to see if BUFY02 works as well as TRB02 in improving signs and symptoms of the condition. This is a randomized, quadruple-masked interventional study sponsored by TRB Chemedica International SA, focused on evaluating effects on dry eye disease over a three-month period. Participants will be assigned to use either BUFY02 or TRB02 eye drops, both containing 0.3% Sodium Hyaluronate but with different buffers, administered as 1 to 2 drops in each eye as needed daily. The study lasts for three months, with participants visiting the trial site at four scheduled timepoints. They will use the assigned treatment every day throughout the study and return any unused medication. During the study, participants will have eye examinations and complete several questionnaires to assess the signs and symptoms of dry eye disease. Researchers will measure the main outcome of signs on day 28 and symptoms on day 28. Safety and treatment adherence will also be monitored. The study aims to provide a thorough comparison between BUFY02 and TRB02 treatments over the participation period.

Efficacy and Safety of BUFY02 Versus TRB02 in the Treatment of Dry Eye Disease