ERIS Phase 4 - Dispensing Pivotal Study
Research type
Research Study
Full title
ERIS Toric Multifocal Contact Lens Dispensing Pivotal Study
IRAS ID
327740
Contact name
Michel Guillon
Contact email
Sponsor organisation
CooperVision International Limited
Duration of Study in the UK
1 years, 0 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 40 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 reach the clinical phase of such development which is a step by step overall process first involving non-dispensing in clinic testing to confirm fit suitability and develop the fitting guide prior to clinical validation as a suitable modality of correction in everyday life and regulatory acceptance.
The overall clinical development process is a four phase process. The current study is is the fourth phase of the process. This dispensing clinical study is Pivotal study following ISO11980 for CE marking to compare the efficacy and safety of the test toric multifocal contact lens (ERIS) with that of MyDay® Multifocal contact lens CE marked contact lens.
REC name
North of Scotland Research Ethics Committee 1
REC reference
23/NS/0041
Date of REC Opinion
28 Apr 2023
REC opinion
Favourable Opinion