Multifocal contact lenses fitting methods comparison
| ISRCTN | ISRCTN51153627 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51153627 |
| IRAS number | 319324 |
| Secondary identifying numbers | CV22-49, IRAS 319324 |
- Submission date
- 11/10/2022
- Registration date
- 26/10/2022
- Last edited
- 02/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Presbyopia is the gradual loss of the eyes' ability to focus on nearby objects. It's a natural, often annoying part of ageing. Presbyopia usually becomes noticeable in the early to mid-40s and continues to worsen until around age 65.
Multifocal contact lenses (contact lenses that correct both distance and near vision for people who need reading glasses) come in very different designs some giving better vision at near or at distance. This study investigates two methods of fitting a marketed multifocal contact lens and compares the vision satisfaction and visual performance achieved with each method.
Who can participate?
Adults aged 40 years old and over who have healthy eyes and are current multifocal contact lens wearers
What does the study involve?
Particiants will attend three study visits over a two-week period:
Visit 1: Screening/Enrolment/Fitting and First Lens Dispensing
Visit 2 (7 +2/-0 days from Visit 1): First Lens follow-up visit, Second Lens Dispensing
Visit 3 (7 +2/-0 days from Visit 2): Second lens follow-up visit/Exit
Each participant attends the clinic on three occasions. At the first visit after being screened and enrolled in the study, their eyes are examined and they are fitted and dispensed with one of the two study contact lenses (which lens pair is used first is randomly determined like tossing a coin). The second visit takes place one week after the first, during that visit the contact lenses which the participant wore are assessed. Then, the participant is fitted and dispensed with the other contact lens pair, which they wear for one week. At the third and final visit, the contact lenses that have been worn are assessed and the participant is discharged from the study.
What are the possible benefits and risks of participating?
The study contact lenses are CE marked and therefore the risks to participants are no different to them wearing their own contact lenses.
Where is the study run from?
Ocular Technology Group - International Research Clinic (UK)
When is the study starting and how long is it expected to run for?
August 2022 to June 2023
Who is funding the study?
CooperVision International Limited (UK)
Who is the main contact?
Deborah Moore (UK)
dmoore@otg.co.uk
Contact information
Public
Ocular Technology Group – International
66 Buckingham Gate
London
SW1E 6AU
United Kingdom
| Phone | +44 (0)7710645211 |
|---|---|
| dmoore@otg.co.uk |
Study information
| Study design | Single-centre non-interventional prospective double-masked randomized crossover trial |
|---|---|
| Primary study design | Other |
| Secondary study design | |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Biofinity® Multifocal contact lenses fitting methods comparison |
| Study acronym | Claret |
| Study objectives | The primary hypotheses tested are: 1. Overall vision satisfaction with the study contact lens after one week of wear is non-inferior for the test contact lens (distance near balanced correction [non-dominant eye Near Design) to that of the control contact lens (distance favoured correction) 2. Overall preference between the study contact lens is non-inferior for the test contact lens (distance near balanced correction) to that of the control contact lens (distance favoured correction) at the completion of the study The secondary hypotheses tested are: 1. Overall binocular visual performance with the study contact lens after one week of wear is non-inferior for the test contact lens (distance near balanced correction) to that of the control contact lens (distance favoured correction) 2. The number of contact lenses to determine the contact lens power to dispense the study contact lens is non-inferior for the test contact lens (distance near balanced correction) to that of the control contact lens (distance favoured correction) |
| Ethics approval(s) | Approved 04/10/2022, London - Bloomsbury Research Ethics Committee (HRA RES Centre Manchester, 3rd Floor Barlow House, 4 Minshull Street, Manchester, M1 3DZ, UK; telephone not provided; bloomsbury.rec@hra.nhs.uk), ref: 22/PR/1137 |
| Health condition(s) or problem(s) studied | Presbyopia |
| Intervention | Multifocal contact lenses are prescribed to provide wearers with good vision satisfaction and visual performance using the manufacturer's prescribing routine. This study will investigate two methods of fitting a marketed multifocal contact lens and compare the vision satisfaction and visual performance achieved with each method. The study is a crossover design so all participants will wear both methods of fitting the contact lenses. Randomisation is limited to the order of testing and is a computer-based randomisation selection process. The participant will wear each contact lens for 1 week and at the end of the week visual satisfaction will be recorded using a 100-point analogue scale for different vision conditions, distance, intermediate and near vision. The visual performance will be measured using computerised logMAR charts at 4m, 67cm and near 40cm. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Biofinity® Multifocal contact lenses |
| Primary outcome measure | 1. Overall binocular vision satisfaction measured using a 100-point visual analogue scale (VAS) after one week of wear 2 Overall preference measured using a forced choice scale at the completion of the study |
| Secondary outcome measures | 1. Mean binocular visual performance measured using timed logMAR mean visual acuity after one week of wear 2. Number of contact lenses needed per participant to determine the contact lens pair to be dispensed |
| Overall study start date | 01/08/2022 |
| Completion date | 15/06/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Sex | Both |
| Target number of participants | 25 |
| Total final enrolment | 25 |
| Key inclusion criteria | 1. Aged 40 years old and over 2. Have read and understood the Participant Information Sheet 3. Have read, signed and dated the Informed Consent 4. Best corrected visual acuity of at least 20/25 in each eye 5. Have normal eyes with the exception of the need for visual correction 6. Current multifocal contact lens wearer 7. Spectacle refraction: 7.1. Distance: 7.1.1. Sphere -6.00D to + 4.00D 7.2.1. Astigmatism 0.00D to -0.75D 7.2. Near Addition: 7.2.1. Established Presbyopes: +1.50D and +1.75D 8. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule |
| Key exclusion criteria | 1. Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear 2. Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator 3. Monocular participants (only one eye with functional vision) or participants fit with only one lens 4. Any moderate or severe ocular condition observed during the slit-lamp examination at the enrolment visit 5. History of herpetic keratitis, ocular surgery or irregular cornea 6. Known pregnancy or lactation during the study period 7. Enrolment of the investigator or his/her staff, family members of the investigator, family members of the investigator’s staff, or individuals living in the households of these individuals |
| Date of first enrolment | 10/10/2022 |
| Date of final enrolment | 01/05/2023 |
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 | +1 925 251 6682 |
|---|---|
| plazon@coopervision.com | |
| Website | https://www.coopervision.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/05/2024 |
|---|---|
| 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 | The protocol and statistical analysis plan are confidential documents from the sponsor and have been reviewed by the Ethics Committee under the usual confidentiality conditions. There are no specific plans for publication or dissemination of the study results. However, an abstract for submission at an ophthalmic conference and/or a peer-reviewed publication may be generated. |
| 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 1.0 | 23/05/2023 | 02/06/2023 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
02/06/2023: Basic results and total final enrolment added.
26/10/2022: Trial's existence confirmed by Health Research Authority (HRA) London - Bloomsbury.
