Clinical Validation Multisite Study CV MF Contact Lenses
Research type
Research Study
Full title
Clinical Validation Multisite Study of CV Multifocal Contact Lenses
IRAS ID
253244
Contact name
Kishan Patel
Contact email
Sponsor organisation
CooperVision, Inc.
Duration of Study in the UK
0 years, 8 months, 25 days
Research summary
Presbyopia is s a condition associated with aging in which the eye exhibits a progressively diminished ability to focus on near objects. When correcting presbyopia with contact lenses, multifocal designs are used to correct vision at far, intermediate and near distances. CooperVision has a new daily disposable contact lens Multifocal contact lens. The lens performance needs to be validated in a dispensing study representing a group of presbyopes with low, medium and high near reading additions and compared with a multifocal contact lens that is widely used on the market 1-DAY ACUVUE® MOIST Multifocal contact lens. This study will provide better understanding of the overall satisfaction, visual performance and selecting the optimal lens for an individual. Up to 180 participants will be screened into three near reading addition groups with a view to enrol up to 150 participants (50 per group). Participants will use both contact lens types (test: CV Multifocal, control:1-Day Acuvue Moist) in a randomized sequence. In the first phase involving up to 30 participants , there will be four study visits over a three-week period with more detailed measurements routine. In phase two, for the remaining participants, there will be three study visits over a two-week period following a simplified routine. Both contact lenses are CE marked and each lens type will be worn for a week on a daily wear basis. Both participant and investigator will be masked.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
18/NW/0705
Date of REC Opinion
19 Oct 2018
REC opinion
Favourable Opinion