Multifocal contact lens performance and acceptance
| ISRCTN | ISRCTN54358864 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54358864 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 274407 |
| Protocol serial number | CV19-84 ID19-50, IRAS 274407 |
| Sponsor | CooperVision (United States) |
| Funder | CooperVision |
- Submission date
- 10/12/2020
- Registration date
- 28/01/2021
- Last edited
- 28/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Contact lenses are small prescription lenses, worn in "contact" with the eye. They are designed to correct eyesight and maintain eye health.
The aim of this study is to determine the acceptance and the vision performance of Miru multifocal contact lenses compared with 1-Day Acuvue® Moist contact lenses.
Who can participate?
Adults who are at least 40 years old and who have healthy eyes and are current multifocal contact lens wearers.
What does the study involve?
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 type is used first is randomly determined like tossing a coin). The second visit takes place 1 week after the first, during that visit the contact lens which the participant wore are assessed. Then, the participant is fitted and dispensed with the other contact lens type, which they wear for 1 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 participants will have the opportunity to try two different types of multifocal contact lenses which they may prefer to their own multifocal contact lenses and at a later date may decide to opt for these lenses. The two contact lens types are CE marked and therefore the risks 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 from and how long is it expected to run for?
August 2019 to December 2020
Who is funding the study?
CooperVision Inc (USA)
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)207 2224224 |
|---|---|
| dmoore@otg.co.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective double-masked randomized cross over pilot feasibility study |
| Secondary study design | Randomised cross over trial |
| Study type | Participant information sheet |
| Scientific title | Miru multifocal contact lens performance and acceptance assessment |
| Study objectives | The overall visual satisfaction and binocular visual performance with Miru multifocal will not be inferior to that of 1 DAY ACUVUE Moist multifocal. |
| Ethics approval(s) | Approved 17/12/2019, North West - Preston Research Ethics Committee (Barlow House 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 (0)207 104 8056; preston.rec@hra.nhs.uk), ref: 19/NW/00713 |
| Health condition(s) or problem(s) studied | Presbyopia vision correction using multifocal contact lenses |
| Intervention | 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 (chosen at random). The randomisation process is 1:1 randomisation using a computerised program. The second visit takes place 1 week after the first, during that visit the contact lens which the participant wore are assessed. Then, the participant is fitted and dispensed with the other contact lens type, which they wear for 1 week. At the third and final visit, the contact lenses that have been worn are assessed and the participant is discharged from the study. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Miru multifocal contact lenses, 1 DAY ACUVUE Moist multifocal contact lenses |
| Primary outcome measure(s) |
Overall binocular vision satisfaction measured on a 100 point Visual Analogue scale at the end of the wearing period 7 +2/-1 days of wear. |
| Key secondary outcome measure(s) |
Overall binocular visual performance measured as the mean of the distance and near LogMar visual acuity after 7 +2/-1 days of wear. |
| Completion date | 14/12/2020 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 45 |
| Total final enrolment | 27 |
| Key inclusion criteria | 1. At least 40 years old 2. Have read and understood the Participant Information Sheet in English 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 soft contact lens wearer 7. Spectacle refraction: Distance: Sphere: -6.00D to + 4.00D Astigmatism: 0.00D to -0.75D Near Addition: +0.75D to +2.50D 8. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule |
| Key exclusion criteria | 1. Currently wearing study contact lenses 2. Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear 3. Newly prescribed use of some systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator 4. Monocular participants (only one eye with functional vision) or participants fit with only one lens 5. Any moderate or severe ocular condition observed during the slit-lamp examination at the enrolment visit 6. History of herpetic keratitis, ocular surgery or irregular cornea 7. Known pregnancy or lactation during the study period 8. 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 | 05/03/2020 |
| Date of final enrolment | 30/08/2020 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
London
SW1E 6AU
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 28/01/2021 | 28/01/2021 | No | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN54358864_BasicResults_28Jan21.pdf
- Uploaded 28/01/2021
Editorial Notes
28/01/2021: The basic results of this trial have been uploaded as an additional file.
28/01/2021: Trial’s existence confirmed by North West - Preston Research Ethics Committee.
