Dry Eye

Ora’s Dry Eye department stands at the forefront of global Dry Eye research with a combination of technology and expertise that no other development firm in the world can match. We are currently working with several of the world’s leading dry eye pioneers to develop the next generation of dry eye treatments.

 Our technologically advanced Controlled Adverse Environment (CAE) model has become widely recognized as the gold standard for conducting ophthalmic pharmaceutical studies for dry eye treatments, with endpoints currently accepted by key regulatory agencies.  Our state-of-the-art technology allows us to implement this highly efficient CAE model in both single-center and multi-center trials.

Ora’s Dry Eye models are precise, reliable, well-controlled, and reproducible. Our clients use them to assess both the treatment effect and the concentration effect of their investigational drugs. More and more companies are looking to Ora’s CAE model because it offers significant advantages over all other dry eye trial designs:

• Shorter timelines because of block enrollment
• Fewer required patients because of extensive screening and pre-selection
• Reduced variability because of our network of experienced investigators and precise evaluation methods and scales

Using state-of-the-art technology, we are equipped to accurately evaluate the most critical clinical endpoints for dry eye; including Ocular Protection Index (OPI), tear film break up time (TFBUT), keratitis, tear production, osmolarity, and impression cytology. Drawing upon our clinical trial management experience, we also are capable of providing site management for single-center and multi-center trials, facilitating rapid patient recruitment and enrollment, full regulatory compliance, and accurate data capture, monitoring, and management.

Our dry eye department has extensive experience in conducting Phase I through IV dry eye trials, including comfort, safety, and pharmacokinetic studies.  We tailor our clinical models to evaluate effectively the strengths of the unique test agents in our clients’ development pipelines.  

Ora’s Dry Eye department is highly dedicated to furthering dry eye and ocular surface research.  We conduct our own internal research on dry eye and ocular surface disease and perform “research on research”, developing new proprietary models and refining existing clinical methods for evaluating dry eye and dry eye therapeutics.  Because of our well-established position as thought leaders in dry eye and our broad knowledge of the industry, clients often ask us to consult on protocol development.  We critically evaluate and consult on safety and efficacy endpoints, visit and dosing schedules, appropriate powering, clinical relevance, market positioning, and adverse event management.

Whether you are a pharmaceutical company searching for sites, a biotech company looking for an experienced research group to act as a "virtual R&D unit" to work with you on a development program, or an investigator interested in becoming part of OraNet (our research site network), Ora’s Dry Eye department is ready to help you reach your goals.

For more information, please contact George Ousler, Director of Dry Eye, at (978) 685-8900, ext. 9481 or by email at gousler@oraclinical.com.