Comfilcon A Contact Lenses Medical Device Regulation Study
Research type
Research Study
Full title
Comfilcon A Contact Lenses Medical Device Regulation Study
IRAS ID
327576
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
Comfilcon A contact lenses are CE marked and have been on the European and UK market for some years under the name of Biofinity® or an alternate private label. The CE marking for these contact lenses was obtained under the applicable Medical Device Directive (1993) rules. The rules are changing to the Medical Device Regulation (2017) which requires the manufacturer to proactively collect clinical data in a controlled manner (clinical study) as part of the regulation post-market follow-up has come into application for all renewals.
Comfilcon A contact lenses are CE marked for both daily and overnight wear of up to seven days for use by children and adults. The rationale for the study is to collect data on long term wearers to a real world setting.
The study is an observational study of long term wearers of comfilcon A contact lenses, with at least 12 months of wear. Potential participants will be identified in practices in London and the south east who currently fit Comfilcon A contact lenses. The practices will make the initial contact with potential participants and if interested and agreeable they will send contact information to Ocular Technology Group – International (OTG-i). OTG-i will give potential participants greater details of the study and schedule the study visit if it is the wish of the potential participant. The visit will be approximately two-hour duration during which after being consented the participants will complete a questionnaire, will have their vision measured, the contact lens fit evaluated and the eye examined. In addition the investigator will review at the practices site the participant clinical notes to ensure that they identify any adverse event associated with wearing comfilcon A contact lenses that may have occurred are identified and analysed.
REC name
London - Riverside Research Ethics Committee
REC reference
23/PR/0414
Date of REC Opinion
9 Jun 2023
REC opinion
Further Information Favourable Opinion