Post-Market Clinical Follow-up for Stenfilcon A Sphere & Toric

• Research type

  Research Study

• Full title

  Post-Market Clinical Follow-up for Stenfilcon A Sphere & Toric CV-23-68

• IRAS ID

  336756

• Contact name

  Craig McArthur

• Contact email

  craig@peterivins.co.uk

• Sponsor organisation

  Cooper Vision

• Clinicaltrials.gov Identifier

  44581, ISRCTN Submission Ref. Approval Pending

• Duration of Study in the UK

  0 years, 3 months, 1 days

• Research summary

  The objective of this post-market study is to demonstrate acceptable safety and effectiveness (performance) of the CE marked Stenfilcon A Sphere & Toric lenses compared with similar marketed state-of-the-art devices, when used in the general population.
  This is a a single visit, observational study to assess outcomes in a real-world environment.
  The primary endpoints are Visual performance (visual acuity), and Incidence of contact lens-related adverse events.
  A person is eligible for inclusion in the study if they are aged 8 to 75 years (inclusive), AND a current wearer of the Stenofilcon A sphere or toric contact lens or similar marketed soft contact lens for at least 6 months

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  24/SC/0070

• Date of REC Opinion

  27 Feb 2024

• REC opinion

  Favourable Opinion