Considerations for Clinical Trials of Dry Eye Syndrome

This white paper discusses the complexities involved in designing clinical trials for Dry Eye Syndrome (DES), focusing on achieving scientific rigor while maintaining operational feasibility. It outlines the challenges faced in this crowded landscape, including high placebo response rates, subjective symptoms, and environmental variability. The paper presents insights from Fortrea's practical experiences in conducting DES trials, including strategies for standardizing diagnostic criteria, improving patient selection, and enhancing patient compliance. It also highlights the increasing interest in DES research, with a notable rise in clinical trials from 2022 to 2024, and the geographical concentration of these trials in Asia and North America. Furthermore, the document details the diverse mechanisms of action being explored in DES therapies and emphasizes the importance of robust trial designs that prioritize symptom assessment and clinical response. Overall, it serves as a comprehensive resource for stakeholders involved in the development of new therapies for Dry Eye Syndrome.