Study of vision achieved with two contact lenses to correct presbyopia (the gradual loss of your eyes' ability to focus on nearby objects)
| ISRCTN | ISRCTN63729760 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63729760 |
| IRAS number | 263503 |
| Secondary identifying numbers | IRAS 263503, ID19-08 CV19-29 |
- Submission date
- 28/01/2021
- Registration date
- 29/01/2021
- Last edited
- 03/02/2021
- 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 your eyes' ability to focus on nearby objects. It's a natural, often annoying part of ageing. Presbyopia usually becomes noticeable in your 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. In order to improve this type of contact lenses it is important to compare how well different designs are tolerated by patient and correct vision.
The study compares the level of vision satisfaction and the visual acuity achieved by two different contact lenses designs currently available.
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 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 lens 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 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?
October 2018 to June 2019
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)2072224224 |
|---|---|
| dmoore@otg.co.uk |
Study information
| Study design | Single-centre prospective randomised (testing order) double-masked cross over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Clariti® multifocal contact lens performance study |
| Study objectives | The overall visual acceptance with the two near addition system will not be inferior to the three near addition system. |
| Ethics approval(s) | Approved 23/04/2019, London - Stanmore Research Ethics Committee (Skipton House, 80 London Road, London, SE1 6LH, UK; +44 (0)207 972 2561; stanmore.rec@hra.nhs.uk), ref: 19/LO/0574 |
| Health condition(s) or problem(s) studied | Presbyopia vision correction using multifocal contact lenses |
| Intervention | The study is a cross over study, the participants wear two CE-marked multifocal contact lenses each for a period of 7 +2/-0 days: 1. clariti® 1-day multifocal (test) 2. MyDay® multifocal combined with clariti® 1-day multifocal (control) The order of testing will be randomised using a standard computerised randomisation software. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Contact lenses, MyDay® multifocal, clariti® 1-day multifocal |
| Primary outcome measure | Overall binocular vision satisfaction measured on a 100-point visual analogue scale (VAS) after 1 week of wear |
| Secondary outcome measures | Overall binocular visual performance measured by LogMAR visual acuity after 1 week of wear |
| Overall study start date | 01/10/2018 |
| Completion date | 14/06/2019 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 20 |
| Key inclusion criteria | 1. Aged at least 40 years 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: Distance: Sphere: -6.00D to + 4.00D Astigmatism: 0.00D to -0.75D Near Addition: +0.75 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. Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear 2. Newly prescribed use of some 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 | 25/04/2019 |
| Date of final enrolment | 07/06/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
SW1E 6AU
United Kingdom
Sponsor information
Industry
6150 Stoneridge Mall Rd
Suite 370
Pleasanton
CA 94588
United States of America
| Phone | +1 9252516682 |
|---|---|
| plazon@coopervision.com | |
| Website | https://coopervision.co.uk/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/07/2021 |
|---|---|
| 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 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 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 | 03/02/2021 | 03/02/2021 | No | No | |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN63729760_BasicResults_03Feb21.pdf
- Uploaded 03/02/2021
Editorial Notes
03/02/2021: The basic results of this trial have been uploaded as an additional file.
01/02/2021: Internal review.
29/01/2021: Trial’s existence confirmed by London - Stanmore Research Ethics Committee.
