ACUVUE OASYS Clinical Performance Registry
Research type
Research Study
Full title
ACUVUE OASYS with Transitions Light Intelligent Technology Clinical Performance Registry
IRAS ID
270094
Contact name
Graeme Young
Contact email
Sponsor organisation
Johnson & Johnson Vison Care (JJVC)
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
This will be a post marketing surveillance study for the newly approved photochromic daily reusable contact lens, ACUVUE® OASYS with Transitions™ and is planned to be conducted in the UK, Spain, and Germany.
The goal of this registry study is to provide real world data on the effectiveness of ACUVUE® OASYS with Transitions™ compared to other marketed non-photochromic contact lenses. The information collected will be from a group of approximately 600 patients (200 per country); 300 will be wearers of the new ACUVUE® OASYS with Transitions™ contact lenses (test lens) and 300 will be wearers of non-photochromic contact lenses (control lens).
There will be approximately 10 sites in the UK, each site will be an Eye Care Practice. Patients (aged 8 or more) from the practice will be invited to register for the study if they have recently (within the last 2 months) purchased and been fitted with either the test or control lenses. Each site is expected to enroll 20 subjects, 10 in each arm.
Participants will register for the study in person with their Eye Care Practitioner, and complete a baseline questionnaire (visit 1). They will then complete three online questionnaires at 2 week, 4 month and 12 month.
The study enrolment period is 12 months, with each participants’ involvement in the study being for 12 months, therefore the study will last approximately two years in the UK.REC name
North West - Preston Research Ethics Committee
REC reference
19/NW/0605
Date of REC Opinion
11 Oct 2019
REC opinion
Further Information Favourable Opinion