Performance and acceptance of spherical vs toric multifocal contact lenses
| ISRCTN | ISRCTN92830937 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92830937 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 294068 |
| Protocol serial number | CV20-97 ID20-77, IRAS 294068 |
| Sponsor | CooperVision International Ltd |
| Funder | CooperVision International Limited |
- Submission date
- 17/03/2021
- Registration date
- 18/03/2021
- Last edited
- 22/09/2021
- 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 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. 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 types currently available for people with presbyopia (needing distance and near vision correction) with astigmatism (a common vision problem caused by an error in the shape of the cornea).
Who can participate
Adults who are at least 40 years old, have healthy eyes, are current multifocal contact lens wearers, and have an astigmatism
What does the study involve?
Each participant attends the clinic on four occasions. At the first visit after being screened and enrolled in the study, their eyes are examined and the study contact lenses are ordered to the research clinic in both types of study contact lens. The second visit takes place once the study contact lenses have arrived at the clinic and are ready to be dispensed. Contact lenses are dispensed in a randomly assigned order. Visit 3 takes place about 1 week later and the contact lenses which the participant wore are assessed. Then, the participant is dispensed with the other contact lens pair, which they wear for 1 week. At the fourth 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 2020 to December 2021
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 |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre interventional randomized crossover double-masked trial |
| Secondary study design | Randomised cross over trial |
| Study type | Participant information sheet |
| Scientific title | Performance and acceptance of spherical vs toric multifocal contact lenses in a low astigmatic population - proof of concept study |
| Study acronym | Harlequin |
| Study objectives | Overall vision satisfaction will not be inferior with toric clariti® multifocal contact lenses than with spherical clariti® 1-day multifocal contact lenses but will trend towards better vision. |
| Ethics approval(s) | Approved 04/03/2021, East of England - Essex Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)2071048106; essex.rec@hra.nhs.uk), REC ref: 21/EE/0034 |
| Health condition(s) or problem(s) studied | Presbyopia and astigmatism |
| Intervention | Multifocal contact lenses are prescribed to provide wearers with good vision satisfaction and visual performance using the manufactures prescribing routine. It is important to compare this feature for a new contact lens with established contact lenses. The study is a cross over study, the participants wear both contact lens types (Biofinity and Pluto daily disposable multifocal contact lenses) for 1 week each, the randomisation is limited to the order of testing, the randomisation process is a computer-based randomisation selection process. Each participant attends the clinic on four occasions. At the first visit after being screened and enrolled in the study, their eyes are examined and the study contact lenses are ordered to the research clinic in both types of study contact lens. The second visit takes place once the study contact lenses have arrived at the clinic and are ready to be dispensed. Contact lenses are dispensed in a randomly assigned order. Visit 3 takes place about 1 week later and the contact lenses which the participant wore are assessed. Then, the participant is dispensed with the other contact lens pair, which they wear for 1 week. At the fourth 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) | |
| Primary outcome measure(s) |
Visual satisfaction measured on a 100-point visual analogue scale after 1 week of wear |
| Key secondary outcome measure(s) |
1. Visual performance measured using LogMAR at distance, intermediate and near and monocularly after 1 week of wear |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 45 |
| Total final enrolment | 24 |
| Key inclusion criteria | There are no requirements as to participant race or gender. In order to be enrolled, each participant shall meet the following criteria: 1. 40 or more years of age 2. Current multifocal contact lens wearer 3. Spectacle refraction: Distance: Sphere: -6.00 D to + 4.00 D Astigmatism Power: -0.50 D to -1.25 D Axis; 180o ± 20o & 90o ± 20o Near addition: at 40 cm: +0.75 D to +2.50 D in three groups: - Emerging presbyopes: +0.75 D to +1.25 D - Established presbyopes: +1.50 D and +1.75 D - Advanced presbyopes: +2.00 D to +2.50 D 4. Best corrected visual acuity of at least 20/25 in each eye |
| Key exclusion criteria | 1. Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear 2. 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 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 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 | 19/03/2021 |
| Date of final enrolment | 31/07/2021 |
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 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 0.1 | 13/09/2021 | 22/09/2021 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN92830937_BasicResults_V0.1_13Sep21.pdf
- Basic results
Editorial Notes
22/09/2021: The following changes have been made:
1. The basic results of this trial have been uploaded as an additional file.
2. The total final enrolment number has been added.
18/03/2021: Trial's existence confirmed by East of England - Essex Research Ethics Committee.
