COSTA MESA, Calif.,/iReach–PRNewswire/WCCT, an international specialized contract research organization, today announced that results from an ophthalmology clinical trial conducted in early 2012 have been published in a recent edition of Clinical Ophthalmology in an article entitled “Pharmacokinetics and safety of olopatadine hydrochloride 0.77% in healthy subjects with asymptomatic eyes: data from 2 independent clinical studies.” The purpose of the study was to assess the pharmacokinetics and safety of hydrochloride ophthalmic solution in healthy subjects, taking data from two independent studies, one Phase I, and one Phase III; the Phase I portion of the study was conducted at WCCT Global’s large Phase I CPU in Cypress, CA.
As a single site, WCCT enrolled a total of 36 healthy adult subjects, half of which were of Japanese descent (as proven by passport, birth certificate, or family tree), aged 18-65 at the time of screening. Key exclusion criteria were history of allergy of hypersensitivity to any component of the test articles, or use of any prescription or non-prescription systemic or topical medications. The rationale for recruiting at least 50% Japanese subjects was that the same population had previously been evaluated for the pharmacokinetics parameters following oral administration of olopatadine.
Subjects were randomized 2:1 to receive olopatadine 0.77% or vehicle; overall, 33 subjects completed the study, and no subjects discontinued due to an AE. The study results concluded that olopatadine 0.77% had minimal systemic exposure or accumulation in healthy subjects and was well tolerated in adult and pediatric subjects.
WCCT’s President of Early Clinical Development, Jon Rojas, commented on the company’s role in the study: “I feel strongly that this particular study was a testament to numerous WCCT Global strengths. It not only demonstrated our ability to conduct an ophthalmology clinical trial in healthy subjects, but also our ability to effectively enroll subjects from Japanese populations locally. WCCT has been successfully conducting ophthalmology clinical research and Japanese bridging studies, and our capabilities in both areas have grown significantly since the time of this program.”
WCCT looks to continue its work in ophthalmology clinical research at its multiple facilities in Orange County, CA, as well as continue partnering with pharmaceutical, biotech, and medical device companies to develop their product globally through Japanese bridging studies.