Glaucoma

Ora has been an expert in glaucoma drug development for over 15 years, and possesses deep expertise in conducting Phase I, II, III, IIIb, and IV trials.

We are experts in a wide range of technical procedures, including fasting blood draws, pharmacokinetic (PK) blood draws, physical exams (by either an MD or RNP), EKGs, evening and middle-of-the-night exams to examine circadian IOP rhythms, laser flare readings, HRT, and fundus photos.

Our clients also rely on us to consult in the development of glaucoma protocols, including safety and efficacy endpoints, visit schedules, dosing schedules, study population size, number of sites required, clinical relevance, quality-of-life, market positioning, and adverse event management. In addition, as a result of our external ocular disease experience, we have also been able to design and conduct studies to investigate drug-induced ocular reactions to glaucoma medications, and have helped to develop standard diagnosis algorithms and grading scales for use in managing adverse events in glaucoma studies.

Ora's glaucoma department consists of an experienced professional research staff, including MDs, ODs, RNs, clinical research associates (CRAs), phlebotomists, ophthalmic technicians, and expert investigator/site and subject recruiters.

Because our glaucoma staff has extensive coordinating, monitoring, and site management experience, our clients often look to us to first conduct pilot studies and then help them rapidly expand their efforts into multi-center trials. We apply our site management skills throughout the country and can serve our clients as a CRO/SMO to help them manage multi-center studies.

During these multi-center trials, we often work with investigators throughout the country who are new to clinical research, and who would be unable to properly conduct these studies on their own. At these sites we provide full study coordination assistance and guidance, including correspondence with the sponsor pharmaceutical company and IRB, recruitment strategies for subjects, and source documentation design. In addition, Ora staff travel to these offices for study visits to help block enroll subjects (including performing blood draws), as well as transcribe and QA case report forms (CRFs).

For more information, please contact Aron Shapiro, Director, at (978) 685-8900, ext. 9443 or by email at glaucoma@oraclinical.com.