Clariti Multifocal Contact Lens Performance Study

  • Research type

    Research Study

  • Full title

    Clariti Multifocal Contact Lens Performance Study

  • IRAS ID

    263503

  • Contact name

    Kishan Patel

  • Contact email

    kpatel@otg.co.uk

  • Sponsor organisation

    CooperVision, Inc.

  • ISRCTN Number

    63729760

  • Duration of Study in the UK

    0 years, 6 months, 1 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. Multifocal lens systems can consist of three near addition powers low, medium and high respectively targeting at emerging, established and advanced presbyopes or two near addition system targeting low and high addition presbyopes. The rationale of the study is to identify if fitting multifocal contact lenses with a system using three near addition achieves a superior visual acceptance and performance than a two near addition system. Up to 60 participants will be screened into three near reading addition groups (up to 20 per group). Participants will use both multifocal contact lens system (test: clariti 2 add system, control: 3 add system) in a randomized sequence for a week wear. There will be three study visits over a two-week period. Both contact lenses are daily disposables, CE marked and each lens type will be worn for a week on a daily wear basis. Lenses will be prescribed as per manufacturer's fitting guide. Both participant and investigator will be masked. Overall visual satisfaction score using visual analog scale 0-100 and visual acuity measurements will be used to compare the test and control systems.

  • REC name

    London - Stanmore Research Ethics Committee

  • REC reference

    19/LO/0574

  • Date of REC Opinion

    23 Apr 2019

  • REC opinion

    Further Information Favourable Opinion