Biofinity Multifocal Contact Lenses vs Pluto Multifocal Contact Lenses
Research type
Research Study
Full title
Performance and Acceptance Study of Biofinity Multifocal Contact Lenses vs. Multifocal Pluto Contact Lenses
IRAS ID
293763
Contact name
Ruchi Gupta
Contact email
Sponsor organisation
CooperVision International Limited
ISRCTN Number
ISRCTN14349364
Duration of Study in the UK
0 years, 5 months, 15 days
Research summary
Presbyopia is a condition associated with ageing in which the eye exhibits a progressively decreased 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 presbyopia program has led to the development of several CE marked systems with different levels of complexity to correct presbyopia. The rationale for the current study is to quantify the relative performance and applicability of two systems (Biofinity® multifocal vs. Pluto 1-day multifocal)
This dispensing study is a comparison of overall visual satisfaction and visual performance of the two contact lens types worn under normal wearing conditions (daily wear for a week) on a contact lens wearing population representative of the full range of presbyopes from emergent presbyopes needing weak near vision correction to advanced presbyopes needing the strongest near vision correction.Up to 60 existing multifocal contact lens wearers will be screened with a view to enroll 45 participants. There will be three study visits over a two-week period. Participants will wear both contact lens types (control: Biofinity Multifocal, test: Pluto multifocal)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
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
21/EE/0030
Date of REC Opinion
29 Jan 2021
REC opinion
Favourable Opinion