Refitting Biofinity® Multifocal contact lenses wearers with MyDay® Multifocal contact lenses
| ISRCTN | ISRCTN13286992 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13286992 |
| IRAS number | 338011 |
| ClinicalTrials.gov number | NCT06328660 |
| Secondary identifying numbers | EX-MKTG-155 ID23-62, IRAS 338011 |
- Submission date
- 02/02/2024
- Registration date
- 09/02/2024
- Last edited
- 14/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English Summary
Background and study aims
Soft contact lenses to correct presbyopia (loss of reading vision due to age) are made of different materials which may affect the ease of handling. Contact lenses to correct presbyopia also have different optical designs that may produce different vision results. The aim of this study is to compare the ease of handling and vision acuity of Biofinity® multifocal contact lenses and MyDay® multifocal contact lenses, two successful contact lenses to correct presbyopia currently CE marked and on the UK market.
Who can participate?
Adults aged 40 years and older who are current soft contact lens wearers and have presbyopia
What does the study involve?
Participants will attend the clinic on three separate occasions about 2 weeks apart. Two different contact lenses will be dispensed at the first two visits and to be worn for approximately two weeks. At visits 2 and 3 the ease of handling and visual acuity will be assessed by the investigators.
What are the possible benefits and risks of participating?
Participants have the opportunity to try contact lenses to correct presbyopia. Any contact lens wear comes at the risk of corneal infection, but the incidence rate is very low
Where is the study run from?
Ocular Technology Group - International (OTG-i) (UK)
When is the study starting and how long is it expected to run for?
November 2023 to June 2024
Who is funding the study?
CooperVision International Limited (UK)
Who is the main contact?
Deborah Moore, dmoore@otg.co.uk
Contact information
Public
66 Buckingham Gate
London
SW1E 6AU
United Kingdom
| Phone | +44 (0)2072224224 |
|---|---|
| dmoore@otg.co.uk |
Scientific, Principal Investigator
66 Buckingham Gate
London
SW1E 6AU
United Kingdom
| Phone | +44 (0)207 222 4224 |
|---|---|
| mguillon@otg.co.uk |
Study information
| Study design | Interventional prospective open-label sequential study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Refitting Biofinity® Multifocal contact lenses wearers with MyDay® Multifocal contact lenses |
| Study hypothesis | The primary hypothesis to be tested will be that the handling of MyDay® multifocal contact lenses will not be inferior to the handling of Biofinity® multifocal contact lenses. The secondary hypothesis to be tested will be that the visual acuity of MyDay® multifocal contact lenses will not be inferior to the mean logMAR visual acuity of Biofinity® multifocal contact lenses. |
| Ethics approval(s) |
Approved 29/12/2023, North East York Research Ethics Committee (2 Redman Place, Stratford London, E20 1JQ, United Kingdom; +44 (0)207 104 8079; york.rec@hra.nhs.uk), ref: 23/NE/0239 |
| Condition | Presbyopia |
| Intervention | The participant will wear in turn the two study contact lenses (Biofinity® Multifocal and MyDay® Multifocal) for 2 weeks as their vision correction modality. The participants will attend the clinic for three study visits about 2 weeks apart. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Biofinity® multifocal, MyDay® multifocal |
| Primary outcome measure | The ease of handling over the week preceding the follow-up visit, measured using subjective ratings and satisfaction questionnaires during the follow-up visits |
| Secondary outcome measures | Visual acuity, measured using logMAR visual acuity recorded during the follow-up visits |
| Overall study start date | 01/11/2023 |
| Overall study end date | 14/06/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Sex | Both |
| Target number of participants | 70 |
| Participant inclusion criteria | 1. Age 40 years and older 2. Current multifocal contact lens wearer (other than MyDay® multifocal but can include Biofinity® multifocal) 3. Spectacle refraction: Distance: Sphere: -6.00D to + 4.00D Astigmatism: 0.00D to -0.75D Near Addition: +0.75D to +2.50D 4. Best corrected visual acuity of at least 20/25 in each eye 5. The prospective participants will be given a Participant Information Sheet to read and an Informed Consent Form to sign prior to any evaluation. |
| Participant exclusion criteria | 1. Acute and subacute inflammation or infection of the anterior chamber of the eye 2. Any eye disease, injury or abnormality that affects the cornea, conjunctiva or eyelids that would contraindicate contact lens wear 3. Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic 4. Severe insufficiency of lacrimal secretion (dry eyes) 5. Any systemic disease that may affect the eye or may be exaggerated by wearing contact lenses (e.g. acne and eczema) 6. Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions 7. Any active corneal infection (bacterial, fungal, protozoal or viral) 8. Newly prescribed (within the past 30 days) use of some systemic medications (such as antihistamines, decongestants, diuretics, muscle relaxants, tranquilizers, stimulants, anti-depressants, anti-psychotics, oral contraceptives) or new prescription eyedrops which is not rewetting/lubricating eyedrops for which contact lens wear could be contraindicated as determined by the investigator 9. Monocular participants (only one eye with functional vision) or participants fit with only one contact lens 10. Subjects with slit lamp findings greater than grade 1 (e.g. edema, infiltrates, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival, anterior segment inflammation) as per ISO 11980, any previous history or signs of a contact lens related corneal inflammatory event (past corneal ulcers), or any other ocular abnormality that may contraindicate contact lens wear at the enrolment visit; 11. History of corneal refractive surgery 12. Enrolment of the family members of the investigator, family members of the investigator’s staff, or individuals living in the households of these individuals 13. Current wearer of the test contact lens MyDay® multifocal contact lens |
| Recruitment start date | 06/02/2024 |
| Recruitment end date | 26/04/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
SW1E 6AU
United Kingdom
Sponsor information
Industry
Delta Park
Concorde Way
Segensworth North, Fareham
PO15 5RL
England
United Kingdom
| Phone | +44 (0)8709000055 |
|---|---|
| jvega2@coopervision.com |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Alternative name(s)
- CooperVision, Inc., CooperVision Inc, CooperVision Inc., CooperVision, Inc
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | There are no plans at this stage for publication or dissemination. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | version 0.2 | 28/10/2024 | 14/11/2024 | No | No |
Additional files
Editorial Notes
14/11/2024: Basic results uploaded.
08/04/2024: ClinicalTrials.gov number added.
02/02/2024: Study's existence confirmed by the North East York Research Ethics Committee.
