The quintessential post-menopausal female dry eye disease patient has now become entirely obsolete. Dry eye disease is an extremely prevalent ocular condition worldwide and with both environmental and genetic factors playing a role, affecting people of all ages and genders. Everyone has come across a loved one or a friend suffering from the signs and symptoms of dry eyes, unable to find relief with their current methods to manage it.
While clinical trials in dry eye disease have been conducted for decades, significant advancements over the past several years have created new approaches to standardize processes, harmonize systems and speed up successful trial completion. In the past, treatments for dry eye disease have solely focused on replenishing tears, but with further understanding of various etiologies of this condition, a polypharmacy approach can be taken to manage this multifactorial disease. The COVID-19 pandemic has accelerated innovation in telehealth, hybrid healthcare partnering in-person visits with online tools and new technologies with at-home patient data capture capabilities. These far-reaching changes have huge implications for patient care quality and treatment access, potentially reinventing doctor-patient dynamics with advanced technology.
Equally exciting is the news that this evolution in healthcare is now making its way to clinical trials. New tools, technologies and regulatory changes are leading to significant shifts in trial design and execution. Various innovative methods and devices are being utilized to standardize clinical trial processes, reduce variability and increase the likelihood of success for drug development. Hybrid or decentralized approaches are opening access to a more diverse patient population, while new technologies generate endpoints that strengthen environmental studies and better assess therapeutic impact on quality of life, all while reducing the burden on sites and impact on budgets of pharmaceutical and medical device companies.
Register to hear the featured speakers discuss how dry eye disease ophthalmic trials are embracing new technologies to accelerate programs and gain better insights into product efficacy.
George W. Ousler III, Senior Vice President, Anterior Segment, Ora
As Senior Vice President of Anterior Segment at Ora, George Ousler oversees all dry eye clinical programs, lending his therapeutic knowledge and expertise to see each project through to completion. He establishes clinical models and regulatory pathways for the evaluation of dry eye therapies and has studied many of the agents under investigation. The Dry Eye Department includes nearly 60 team members who work with global clients in the US, Europe and Asia.
George has over 20 years of pioneering pharmaceutical development experience in dry eye research. He is frequently called on to consult on worldwide drug development and registration. He has authored more than 250 publications on the topic and has been invited to present his research at numerous national and international symposia. He also holds several patents on techniques, formulations and methods in the area of dry eye and related conditions.
Dr. Ethan Bensinger, PhD, Clinical Scientist, Ora Research & Development
As a Clinical Scientist for Ora Research and Development, Dr. Bensinger helps create and improve upon clinically meaningful diagnostic tests, and develops novel technologies used to make ophthalmic clinical research more efficient, accurate and patient-centric. He also constructs systems used to evaluate the suitability and effectiveness of currently accepted endpoints, or to investigate new ones.
Dr. Bensinger conducts research on a variety of ophthalmic conditions, authoring or co-authoring multiple research publications printed in academic journals, and presenting posters or papers at industry research conferences. With more than half a decade of formal ophthalmic research experience, Dr. Bensinger specializes in retinal imaging and optics, with a focus on structure and function relationships.
Maurice Marquis, R&D Systems Engineer, Ora
As a dedicated Systems Engineer for research and development, Maurice constructs the software systems behind some of Ora’s proprietary devices and diagnostic tests, building platforms that allow for maximum clinical functionality while providing the necessary flexibility for easy patient use.
By making iterative, data-driven decisions and leveraging machine learning algorithms, Maurice optimizes software to accommodate the demands of various ophthalmic diseases and enable consistent patient data input, even without the assistance of technicians.
For over 20 years Maurice has built and optimized complex computer systems, including implementing and maintaining enterprise-level IT infrastructure, while creating and utilizing automation to improve processes. He consults with and advises Ora research scientists on the development of novel research technologies and develops software systems in parallel.
Who Should Attend?
- Clinical trial sponsors
- Investigators and medical professionals executing clinical trials in their practice
- Leaders of clinical development start-ups
- Ophthalmic medical professionals interested in clinical research
What You Will Learn
- Smart protocol design and endpoint selection when conducting hybrid/decentralized trials
- Tools for dry eye disease trial administration and improved endpoints, including
- Review of a new remote imaging and data capture platform
- Review of Ora’s Controlled Adverse Environment Dry Eye Challenge (CAE 2.0) and the ability to minimize variability with precision
- The right way to balance new technologies and approaches with traditional practices to ensure protocol compliance and data integrity
Ora is the world’s leading full-service ophthalmic drug and device development firm with offices in the United States, United Kingdom, Australia, and Asia. For over 40 years, we have proudly helped our clients earn more than 50 product approvals. We support a wide array of organizations, from start-ups to global pharmaceutical and device companies, to efficiently bring their new products from concept to market. Ora’s pre-clinical and clinical models, unique methodologies, and global regulatory strategies have been refined and proven across thousands of global projects. We bring together the world’s most extensive and experienced team of ophthalmic experts, R&D professionals, and management executives to maximize the value of new product initiatives.