ERIS Phase 3 - Dispensing Validation Study
Research type
Research Study
Full title
ERIS Toric Multifocal Contact Lens Development Phase 3 Dispensing Fitting Method Comparison
IRAS ID
327703
Contact name
Michel Guillon
Contact email
Sponsor organisation
CooperVision International Limited
Duration of Study in the UK
1 years, 4 months, 1 days
Research summary
Presbyopia is the need to have different vision corrections for near and far vision for people over the age of 40 years. Presbyopia is corrected by multifocal contact lenses that produce different correction for distance and near. Many such contact lens are available which correct long or short sight at far and compensate for presbyopia at near. However, 40% of the adult population suffers also from astigmatism, that is the need to have different vision corrections for far vision; astigmatism is corrected by toric contact lenses.
CooperVision, the study sponsor, produces both CE marked MyDay® Multifocal and MyDay® Toric to respectively correct presbyopia and astigmatism. As 40% of the over 40s are affected by both presbyopia and astigmatism a contact lens combining both correction is needed. The development of such contact lens in the MyDay family has reached the clinical phase of such development which is a step by step overall process.
The overall clinical development process is a four phase process. The current study is a dispensing study and the third phase of the process. This dispensing clinical study is to compare the performance and acceptance of the toric multifocal contact lens (Eris) with historical data for MyDay® Toric contact lens.
The rationale for the selection of this third phase study is that multifocal contact lenses must achieve suitable level of visual performance and acceptance to be acceptable as main modality of vision correction over at least one week of wear. Hence, the comparison of visual performance and acceptance to demonstrate non-inferiority with historical MyDay® multifocal which has been shown to be successful at correcting presbyopia for myopes and hyperopes without astigmatism.
REC name
North of Scotland Research Ethics Committee 1
REC reference
23/NS/0039
Date of REC Opinion
28 Apr 2023
REC opinion
Favourable Opinion