Visual performance of early presbyopes fitted with contact lenses
| ISRCTN | ISRCTN14596554 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14596554 |
| Integrated Research Application System (IRAS) | 373390 |
| Protocol number | CV26-29 |
| Sponsor | CooperVision International Limited |
| Funder | CooperVision International Limited |
- Submission date
- 25/08/2026
- Registration date
- 27/08/2026
- Last edited
- 26/08/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
The aim of the current study is to compare the vision performance of MyDay sphere & MyDay Energys in a group of 40 to 50 year old participants.
Who can participate?
Adult patients aged between 40 to 50 years with early presbyopia.
What does the study involve?
The participants will attend the clinic for two study visits :
During the first visit the participant will be fitted with the control contact lenses and their study contact lens prescription will be determined.
During the second visit the participant will be fitted with both the test and control study contact selected in random order. The visual performance and quality of vision will be assessed by the investigators.
What are the possible benefits and risks of participating?
Participants have the opportunity to try contact lenses.
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, London.
When is the study starting and how long is it expected to run for?
This study will start in August 2026 and run for 12 months.
Who is funding the study?
CooperVision International Limited.
Who is the main contact?
Deborah Moore, dmoore@otg.co.uk
Contact information
Principal investigator, Scientific
66 Buckingham Gate
London
SW1E 6AU
United Kingdom
| Phone | +44 02072224224 |
|---|---|
| mguillon@otg.co.uk |
Public
66 Buckingham Gate
London
SW1E 6AU
United Kingdom
| Phone | +44 07015665390 |
|---|---|
| dmoore@otg.co.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Active |
| Assignment | Crossover |
| Purpose | The primary purpose of the study will be to compare the visual performance, in conditions representing everyday challenging visual environments, of MyDay® Energys® contact lenses with that of MyDay® sphere in a population of 40 to 50 years old. |
| Scientific title | Visual performance of early presbyopes fitted with contact lenses |
| Study objectives | The primary objective of the study will be to compare the visual performance, in conditions representing everyday challenging visual environments, of MyDay® Energys® contact lenses with that of MyDay® sphere in a population of 40 and over years old with emergent presbyopia. |
| Ethics approval(s) |
Approved 24/07/2026, West of Scotland REC 5 (Admin Building, Level 2, Gartnavel Royal Hospital, 1055 Great Western Road, Glasgow, G12 0XH, United Kingdom; Not available; ggc.wosrec5@nhs.scot), ref: 26/WS/0107 |
| Health condition(s) or problem(s) studied | Early presbyopia |
| Intervention | Up to 30 potential participants will attend the research clinic for the first visit (screening / enrolment / test familiarisation visit) to initially obtain their informed consent and screen them for their suitability to take part in the investigation. They will be asked to attend the clinic wearing their spectacles, the potential participants will not have worn their contact lenses prior to the visit the day of the visit. After informed consent has been given, the investigator will review the participant’s medical history, ocular history (including concomitant treatments), demographics and contact lens wear history. A series of routine optometric assessments and tests will be conducted to determine the participant’s prescription and evaluate the participant’s ocular health. Once it has been verified that the participants meet the inclusion/exclusion criteria they will be considered as enrolled, and they will be fitted with the control contact lenses and familiarize with the study tests. At the conclusion of the visit the participants will be scheduled to attend the study test visit. The participants will return for the second visit (test visit) wearing their spectacles and will not have worn their contact lenses prior to the visit the day of the visit. Their concomitant medications will once again be reviewed. The test or control contact lens (randomised) will be inserted and worn for 15 minutes. 15 minutes later a set of visual performance tests and vision quality questionnaires will be carried out. The order 1 study contact lens will be removed, and the second contact lens will be inserted, and the same routine will be repeated. At the end of the study contact lens order 2 will be removed and safety ocular integrity evaluation will be carried before discharge from the study. |
| Intervention type | Device |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | MyDay® sphere & MyDay® Energys® |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 30/11/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Upper age limit | 50 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Key inclusion criteria | 1. Age 40 to 50 years old 2. Have read and understood the participant Information Sheet 3. Have read, signed and dated the Informe Consent 4. Best corrected visual acuity of at least 20/25 in each eye 5. Have normal eyes with the exception of the need for visual correction 6. Current single vision contact lenses wearer. 7. Spectacle refraction: 7.1. Distance Sphere: -6.00D to + 2.00D 7.2. Astigmatism: 0.00D to -0.75D 7.3. Near Addition: +0.50D & +0.75D 8. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule |
| 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. Monovision wearer 11. Subjects with slit lamp findings greater than grade 1 (e.g. Oedema, 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 12. Pregnancy, lactating, History herpetic keratitis 13. History of corneal refractive surgery 14. 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 | 30/08/2026 |
| Date of final enrolment | 10/11/2026 |
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
26/08/2026: Study’s existence confirmed by the West of Scotland Research Ethics Service, UK.
