Comparative performance & acceptance of 2 Multifocal CLs
Research type
Research Study
Full title
Comparative performance and acceptance validation study of CooperVision multifocal contact lenses vs. 1-Day Acuvue® Moist contact lenses.
IRAS ID
241098
Contact name
Kishan Patel
Contact email
Sponsor organisation
CooperVision, Inc.
Duration of Study in the UK
0 years, 6 months, 0 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 established lens fitting guide for its multifocal contact lenses. This dispensing study is a verification study of the overall visual satisfaction and visual performance of the contact lenses worn under normal wearing conditions (daily disposable for a week) in comparison to another multifocal contact lenses that is well accepted and extensively used by the presbyopic population. The study will also enable precise sample size calculation for a multi-sites study. Sixty existing multifocal contact lens wearers will be screened. There will be three study visits over a two-week period. Participants will use both contact lens types (test: CV Multifocal, control:1-Day Acuvue Moist)in a randomised sequence. 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
London - Harrow Research Ethics Committee
REC reference
18/LO/0162
Date of REC Opinion
5 Feb 2018
REC opinion
Further Information Favourable Opinion