Refitting Biofinity Multifocal wearers with MyDay Multifocal
Research type
Research Study
Full title
Refitting Biofinity Multifocal Contact Lenses Wearers with MyDay Multifocal Contact Lenses.
IRAS ID
338011
Contact name
Michel Guillon
Contact email
Sponsor organisation
CooperVision International Limited (CVIL)
ISRCTN Number
ISRCTN13286992
Duration of Study in the UK
0 years, 7 months, 18 days
Research summary
Research Summary:
Biofinity® multifocal contact lenses and MyDay® multifocal contact lenses are two successful contact lenses to correct presbyopia currently CE marked and on the UK market. Biofinity® multifocal contact lenses fitting process is relatively time consuming as it involves the selection of the best prescription from eight different designs. MyDay® multifocal, a more recently developed, only uses three designs to fit the same population of presbyopes. The simpler fitting system results in less chair time benefiting the eyecare practitioner and the patient.
The aim of the study will be to test the hypothesis that successful Biofinity multifocal contact lens wearers can be successfully refitted with MyDay® multifocal. Current successful multifocal contact lens wearers will be enrolled in the study and first fitted with Biofinity® multifocal contact lenses. Once adapted to Biofinity® multifocal contact lenses they will be refitted with MyDay® multifocal contact lenses.
The study design differs from habitual masked ,cross-over studies that test the relative acceptance and performance of two competitive designs. In this study the investigators and participants will not be masked and all the participants be fitted sequentially with Biofinity® multifocal and MyDay® multifocal, the study being designed to reproduce the clinical situation of interest.
The parameters measured to assess success cover all aspects of contact lens wear: contact lens handling (contact lens insertion and removal), vision achieved (visual acuity) and subjective acceptance (comfort and vision).
Each participant will be in the study for four to five weeks, wearing each contact lens type for two weeks (± three days). They will be wearing the contact lenses on a daily wear daily disposable modality (contact lenses removed before sleep, discarded with an identical new pair the following day).
The study will be carried out a single site (Ocular Technology Group – International clinic (66 Buckingham Gate, London).Lay Summary of Results:
The objective of the study was to assess the possibility of refitting Biofinity® multifocal contact lens wearers with MyDay® multifocal.
The primary endpoint tested was overall ease of handling, with additional questions regarding insertion and removal specifically. The primary hypothesis that overall ease handling of MyDay ® multifocal was non-inferior to that of Biofinity® multifocal was not demonstrated. Similarly, ease of insertion non-inferiority was not demonstrated but ease of removal was.
The secondary endpoint overall visual acuity combined visual acuity at far, intermediate and near under the conditions of the test was similarly good for the two contact lenses and non-inferiority in visual acuity for MyDay® multifocal compared with Biofinity® multifocal was demonstrated.REC name
North East - York Research Ethics Committee
REC reference
23/NE/0239
Date of REC Opinion
3 Jan 2024
REC opinion
Favourable Opinion