Benefits of fitting non contact lens wearers with astigmatism with MyDay® 1-day toric contact lenses
| ISRCTN | ISRCTN26395413 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26395413 |
| IRAS number | 354030 |
- Submission date
- 18/03/2025
- Registration date
- 26/03/2025
- Last edited
- 18/03/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Some clinical evidence suggests that eye discomfort with soft toric contact lenses is different to that experienced by spherical soft contact lens wearers.
The aim of this study is to assess and compare eye comfort during contact lens wear with spherical and toric soft contact lenses in population of non contact lens wearers.
Who can participate?
Adults aged 18 to 35 years with no previous contact lens wearing experience
astigmatism (imperfection in the curvature of the eye)
What does the study involve?
The participants will attend the clinic for two study visits and will complete a series of questionnaires while wearing the study contact lenses. At the first visit the participant will be fitted with the relevant study contact lenses MyDay spherical for the control group and MyDay toric for the test group.
The study contact lenses will be worn for one month under daily disposable wearing modality. At visit 2 comfort and the vision satisfaction will be assessed by the investigators.
What are the possible benefits and risks of participating?
Participants have the opportunity to try contact lenses to correct their astigmatism. 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?
March 2025 to October 2025
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 2072224224 |
|---|---|
| MGuillon@otg.co.uk |
Public
66 Buckingham Gate
London
SW1E 6AU
United Kingdom
| Phone | +44 2072224224 |
|---|---|
| dmoore@otg.co.uk |
Study information
| Study design | Interventional open-label prospective investigator masked study following a parallel group study design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Benefits of fitting neophyte astigmat with MyDay® 1-Day toric contact lenses |
| Study objectives | The primary hypothesis to be tested is that ocular comfort of neophytes astigmats fitted with the MyDay® 1-Day toric contact lenses is non-inferior to ocular comfort of neophytes non-astigmats or exhibiting very low astigmatism fitted with MyDay® 1-Day Asphere contact lenses. The secondary hypothesis to be tested is that the vision satisfaction of neophytes astigmats fitted with the MyDay® 1-Day toric contact lenses is non-inferior to vision satisfaction of neophytes non-astigmats or exhibiting very low astigmatism fitted with MyDay® 1-Day Asphere contact lenses. |
| Ethics approval(s) |
Approved 12/03/2025, North of Scotland Research Ethics Committee (Summerfield House, 2 Eday Road, Aberdeen, AB15 6RE, United Kingdom; +44 1224558458; gram.nosres@nhs.scot), ref: 25/NS/0025 |
| 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 while wearing the study contact lenses. At the first visit the participant will be fitted with the relevant study contact lenses MyDay spherical for the control group and MyDay toric for the test group. The study contact lenses will be worn for one month under daily disposable wearing modality. At visit 2 comfort and the vision satisfaction will be assessed by the investigators. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | MyDay® 1-Day Toric® & MyDay® 1-Day Asphere |
| Primary outcome measure | Ocular comfort on a 100-point visual analog scale during the one month study visit |
| Secondary outcome measures | Vision satisfaction on a 100-point visual analog scale during the one month study visit. |
| Overall study start date | 04/01/2025 |
| Completion date | 31/10/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 35 Years |
| Sex | Both |
| Target number of participants | 50 |
| Key inclusion criteria | 1. Age 18 to 35 years 2. No previous contact lens wearing experience 3. Spectacle refraction: Sphere: -6.00D to + 2.00D Astigmatism: Control group: 0.00D to -0.50D in each eye Test group: -0.75D to -2.00D in each eye 4. 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 per ISO 11980, 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. |
| Date of first enrolment | 30/03/2025 |
| Date of final enrolment | 31/10/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
SW1E 6AU
United Kingdom
Sponsor information
Industry
Delta Park, Concorde Way
Segensworth North
Fareham
PO15 5RL
England
United Kingdom
| Phone | +44 (0)19252516682 |
|---|---|
| PLazon@coopervision.com | |
| Website | https://coopervision.com |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Alternative name(s)
- CooperVision, Inc., CooperVision Inc, CooperVision Inc., CooperVision, Inc
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | There are no plans at this stage for publication or dissemination. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
18/03/2025: Trial's existence confirmed by North of Scotland Research Ethics Committee.
