Toric multifocal contact lens development
| ISRCTN | ISRCTN66819383 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66819383 |
| Integrated Research Application System (IRAS) | 327300 |
| Protocol serial number | CV23-08 |
| Sponsor | CooperVision International Ltd |
| Funder | CooperVision |
- Submission date
- 25/01/2024
- Registration date
- 26/01/2024
- Last edited
- 30/09/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
MyDay® Multifocal contact lenses with spherical distance vision correction are CE marked for the correction of presbyopia in patients with no or low levels of astigmatism. MyDay® Toric contact lenses are CE marked for the correction of astigmatism. Population demographics revealed that 40% of the adult population is also affected by astigmatism requiring correction to achieve good vision, hence, requiring to be fitted with multifocal contact lenses with astigmatic correction.
CooperVision is expanding the MyDay® contact lens portfolio to develop a new toric multifocal daily disposable silicone hydrogel contact lens to correct both presbyopia and astigmatism
The purpose for this non-dispensing clinical study is to confirm that the fitting guide for Investigational Toric Multifocal contact lens is not different from MyDay® Toric and MyDay® Multifocal.
Who can participate?
Adults who are current soft contact lens wearers, age 40 years and older with astigmatism and presbyopia
What does the study involve?
The participants attended the clinic for one study visit. They were fitted with the study contact. Up to three fit attempts were allowed to achieve the optimal study contact lens fit. The visual satisfaction and vision performances were evaluated with optimal study contact lens.
What are the possible benefits and risks of participating?
Participants have the opportunity to try contact lenses to correct their presbyopia and astigmatism
Any contact lens wear comes at the risk of corneal infection, but the incidence rate is very low
Where is the study run from?
Ocular Technology Group - international (OTG-i).
When is the study starting and how long is it expected to run for?
May 2024 to October 2024.
Who is funding the study?
CooperVision International Limited (UK).
Who is the main contact?
Deborah Moore
dmoore@otg.co.uk
Contact information
Scientific, Principal investigator
66 Buckingham Gate
London
SW1E 6AU
United Kingdom
| Phone | +44 (0)207 222 4224 |
|---|---|
| mguillon@otg.co.uk |
Public
66 Buckingham Gate
London
SW1E 6AU
United Kingdom
| Phone | +44 (0)207 222 4224 |
|---|---|
| dmoore@otg.co.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | N/A: single arm study |
| Masking | Open (masking not used) |
| Control | Historical |
| Assignment | Single |
| Purpose | to confirm that the fitting guide for Investigational Toric Multifocal contact lens is not different from MyDay® Toric and MyDay® Multifocal |
| Scientific title | Toric multifocal contact lens development phase 2 non-dispensing prescribing methodology validation |
| Study objectives | The primary objective was to confirm the fitting guide for ERIS Toric Multifocal test contact lens. The secondary objectives of the study was to measure overall visual performance. |
| Ethics approval(s) |
Approved 22/05/2023, South East Scotland Research Ethics Committee 2 (2nd Floor, Waverley Gate, 2-4 Waterloo Place, Edinburgh, EH1 3EG, United Kingdom; +44 (0)131 536 9000; ruth.fraser4@nhslothian.sct.nhs.uk), ref: 23/SS/0052 |
| Health condition(s) or problem(s) studied | Presbyopia, astigmatism |
| Intervention | The participants were fitted with the study contact. Up to three fit attempt were allowed to achieve the optimal study contact lens fit. The visual satisfaction and vision performances were evaluated with optimal study contact lens. |
| Intervention type | Device |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | ERIS toric multifocal |
| Primary outcome measure(s) |
The prevalence of first pair successful fit to arrive to the dispensed contact lenses |
| Key secondary outcome measure(s) |
Combined binocular distance and near time controlled logMAR visual acuities |
| Completion date | 30/10/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Lower age limit | 40 Years |
| Upper age limit | 90 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Total final enrolment | 31 |
| Key inclusion criteria | 1. Aged 40 years or older to match the target population for the test product 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. Normal eyes, with the exception of the need for visual correction 6. Current contact lens wearer 7. Spectacle refraction meeting the following criteria: 7.1. Distance sphere: -9.00 D to +3.00 D 7.2. Astigmatism: -0.75 D to -2.25 D 7.3. Axis: within 10° of the study contact lens axes 7.4. Near addition: +0.75 D to +2.50 D 8. Willing and able to adhere to the instructions set out in the clinical protocol and maintain the appointment schedule 9. Healthy volunteers are allowed |
| 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 fitted 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. The investigator or their staff, family members of the investigator, family members of the investigator’s staff, or individuals living in the households of any of these individuals |
| Date of first enrolment | 08/05/2024 |
| Date of final enrolment | 30/10/2024 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
London
SW1E 6AU
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
30/09/2026: The information for which publication was previously deferred has been added to the following fields:
1. The public title
2. The scientific title
3. Study hypothesis
4. Condition
5. Interventions
6. Drug name(s)
7. Primary outcome measure
8. Secondary outcome measures
9. Participant inclusion criteria
10. Participant exclusion criteria
11. Plain English summary
In addition the following changes were made to the study record:
1. The Date of first enrolment was changed from 01/02/2024 to 08/05/2024
2. The Date of final enrolment was changed from 01/02/2025 to 30/10/2024
3. The Completion date was changed from 01/02/2025 to 30/10/2024
25/01/2024: Study's existence confirmed by the HRA.
