Performance and acceptance of spherical vs toric multifocal contact lenses

ISRCTN ISRCTN92830937
DOI https://doi.org/10.1186/ISRCTN92830937
IRAS number 294068
Secondary identifying numbers CV20-97 ID20-77, IRAS 294068
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Ms Deborah Moore
Public

66 Buckingham Gate
London
SW1E 6AU
United Kingdom

Phone +44 (0)2072224224
Email dmoore@otg.co.uk

Study information

Study designSingle-centre interventional randomized crossover double-masked trial
Primary study designInterventional
Secondary study designRandomised cross over trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titlePerformance and acceptance of spherical vs toric multifocal contact lenses in a low astigmatic population - proof of concept study
Study acronymHarlequin
Study objectivesOverall 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) studiedPresbyopia and astigmatism
InterventionMultifocal 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 typeDevice
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measureVisual satisfaction measured on a 100-point visual analogue scale after 1 week of wear
Secondary outcome measures1. Visual performance measured using LogMAR at distance, intermediate and near and monocularly after 1 week of wear
2. Lens centration measured using a 4-point forced-choice scale at Visits 3 and 4
3. Lens movement measured using a 5-point forced-choice scale at Visits 3 and 4
4. Intention to purchase measured using a 5-point forced-choice scale at Visits 3 and 4
5. Overall preference measured using a forced-choice scale with two alternatives at Visits 3 and 4
Overall study start date28/08/2020
Completion date31/12/2021

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsUp to 45 screened
Total final enrolment24
Key inclusion criteriaThere 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 criteria1. 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 enrolment19/03/2021
Date of final enrolment31/07/2021

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Optometric Technology Group - International
66 Buckingham Gate
London
SW1E 6AU
United Kingdom

Sponsor information

CooperVision International Ltd
Industry

Delta Park
Concorde Way
Segensworth North
Fareham
Fareham
PO15 5RL
United Kingdom

Phone +1 (0)925 2516615
Email tdoan@coopervision.com
Website https://coopervision.com/

Funders

Funder type

Industry

CooperVision International Limited

No information available

Results and Publications

Intention to publish date30/08/2022
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planThere are currently no plans for publication and public dissemination of the study results.
IPD sharing planThe 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

Additional files

ISRCTN92830937_BasicResults_V0.1_13Sep21.pdf

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.