Comparative evaluation of myDay® contact lenses handling
| ISRCTN | ISRCTN16940308 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16940308 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 361079 |
| Protocol serial number | CV25-26 ID25-36 |
| Sponsor | CooperVision International Limited |
| Funder | CooperVision |
- Submission date
- 05/11/2025
- Registration date
- 05/11/2025
- Last edited
- 05/11/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
MyDay® sphere and MyDay® Toric have been shown to performed very well, however, for both contact lens types handling is sometimes reported to be poorer than expected. Handling being an important parameter influencing acceptance by patients it is necessary to gain detailed understanding of handling performance.
The rationale of this study is to characterise the handling performance of MyDay® sphere and MyDay® Toric and measure the effect of lens design/geometry aspect on contact lens handling by comparing the two designs.
Who can participate?
Adults aged 18 to 40 years with previous experience wearing soft contact lenses.
What does the study involve?
The participants will attend the clinic for two study visits and will complete a series of questionnaires during each visit while wearing the study contact lenses . At the first visit the participant will be fitted with the relevant study contact lenses as per the randomization MyDay spherical or MyDay toric. At visit 2 the participant will be fitted with the study contact lenses not fitted at visit 1.
What are the possible benefits and risks of participating?
Participants have the opportunity to try contact lenses to correct their vision. Any contact lens wear comes at the risk of corneal infection, but the incidence is very low.
Where is the study run from?
Ocular Technology Group - International (OTG-i) (UK)
When is the study starting and how long is it expected to run for?
September 2025 to December 2025
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 2072224224 |
|---|---|
| dmoore@otg.co.uk |
Scientific, Principal investigator
66 Buckingham Gate
London
SW1E 6AU
United Kingdom
| Phone | +44 2072224224 |
|---|---|
| mguillon@otg.co.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-dispensing non interventional prospective double masked within and between group comparisons experimental design involving two clinic visits |
| Secondary study design | Parallel group, cross over randomized within the group |
| Study type | Participant information sheet |
| Scientific title | Comparative evaluation of MyDay® contact lenses handling |
| Study objectives | The objective of the study will be to compare the overall ease of handling of MyDay® sphere and MyDay® Toric. |
| Ethics approval(s) |
Approved 19/08/2025, Wales REC 3 (Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, United Kingdom; +44 2922 940963; Wales.REC3@wales.nhs.uk), ref: 25/WA/0255 |
| Health condition(s) or problem(s) studied | Astigmatism |
| Intervention | The participants will attend the clinic for two study visits and will complete a series of questionnaires during each visit while wearing the study contact lenses . At the first visit the participant will be fitted with the relevant study contact lenses as per the randomization MyDay spherical or MyDay toric. At visit 2 the participant will be fitted with the study contact lenses not fitted at visit 1. The participants will wear each pair of contact lenses for one week, attending a dispense and follow up visit for each contact lens. The randomisation process is through an online tool. |
| Intervention type | Device |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | MyDay® 1-Day Toric® & MyDay® 1-Day Asphere |
| Primary outcome measure(s) |
Overall ease of handling on a 100-point visual analog scale at baseline/dispense and 7 day follow up visit. |
| Key secondary outcome measure(s) |
Measured at baseline/dispense and 7 day follow up visit: |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 40 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Key inclusion criteria | 1. Age 18 to 40years 2. Current daily disposable: Control Contact lens: spherical contact lens wearers Test contact lens: Toric contact lens wearers 3. Spectacle refraction: Distance: Sphere: -6.00D to + 2.00D Astigmatism: 0.00D to -2.25D in each eye Best corrected visual acuity of at least 20/25 in each eye |
| Key exclusion criteria | 1. Acute and subacute inflammation or infection of the anterior chamber of the eye. 2. Any eye disease, injury or abnormality that affects the cornea, conjunctiva or eyelids that would contraindicate contact lens wear. 3. Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic. 4. Severe insufficiency of lacrimal secretion (dry eyes). 5. Any systemic disease that may affect the eye or may be exaggerated by wearing contact lenses (e.g. acne and eczema). 6. Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions. 7. Any active corneal infection (bacterial, fungal, protozoal or viral). 8. 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. 9. Monocular participants (only one eye with functional vision) or participants fit with only one contact lens. 10. Subjects with slit lamp findings greater than grade 1 (e.g. edema, infiltrates, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival, anterior segment inflammation) as recorded during the clinical visit, any previous history or signs of a contact lens related corneal inflammatory event (past corneal ulcers), or any other ocular abnormality that may contraindicate contact lens wear at the enrolment visit. 11. History of corneal refractive surgery. 12. Enrolment of the family members of the investigator, family members of the investigator’s staff, or individuals living in the households of these individuals. 13. Current wearer of the control contact lenses MyDay® spherical, or the test contact lenses MyDay Toric®. |
| Date of first enrolment | 10/09/2025 |
| Date of final enrolment | 31/12/2025 |
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 | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/11/2025: Trial's existence confirmed by Wales REC 3.
