ACUVUE® OASYS MAX 1-day dispensing study
| ISRCTN | ISRCTN17278168 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17278168 |
| Integrated Research Application System (IRAS) | 373194 |
| Protocol number | CV26-31 |
| Sponsor | CooperVision International Limited |
| Funder | CooperVision |
- Submission date
- 15/07/2026
- Registration date
- 15/07/2026
- Last edited
- 15/07/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
The rationale for the current study is to produce a detailed characterization of the contact lens design acceptance and performance
Who can participate?
Soft contact lens wearers from 40 years and older can participate.
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 study contact lenses. a set which visual measurements and questionnaires will be carried out. at the end the visit 1 the participant will be dispensed with the study contact lenses to wear for 8 to 12 days and a follow up visit will scheduled
At visit 2 visual performance comfort and the vision satisfaction will be assessed by the investigators.
What are the possible benefits and risks of participating?
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 July 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
Public
Ocular Technology Group
66 Buckingham Gate
London
SW1E 6AU
United Kingdom
| Phone | +44 02072224224 |
|---|---|
| dmoore@otg.co.uk |
Principal investigator, Scientific
Ocular Technology Group
66 Buckingham Gate
London
SW1E 6AU
United Kingdom
| Phone | +44 02072224224 |
|---|---|
| mguillon@otg.co.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | N/A: single arm study |
| Masking | Open (masking not used) |
| Control | Uncontrolled |
| Assignment | Single |
| Purpose | Basic science |
| Scientific title | ACUVUE® OASYS MAX 1-day multifocal for astigmatism dispensing study |
| Study objectives | The study objective is to evaluate the performance and the acceptance of the study contact lenses |
| Ethics approval(s) |
Approved 06/07/2026, North West - Preston Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; Not available; preston.rec@hra.nhs.uk), ref: 26/NW/0191 |
| Health condition(s) or problem(s) studied | Presbyopia & Astigmatism |
| Intervention | The participants will attend the clinic for two study visits : At the first visit the participant will be fitted with the study contact lenses. A set of visual measurements and questionnaires will be carried out. At the end the visit 1 the participant will be dispensed with the study contact lenses to wear for 8 to 12 days and a follow up visit will scheduled. At visit 2 visual performance comfort and the vision satisfaction will be assessed by the investigators. |
| Intervention type | Device |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | ACUVUE® OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 01/09/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 40 Years |
| Upper age limit | 85 Years |
| Sex | All |
| Target sample size at registration | 45 |
| Key inclusion criteria | 1. Age 40 years or greater 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 soft contact lenses wearer 7. Spectacle refraction: 7.1 Distance Sphere: −6.00 D to −0.50 D 7.2 Astigmatism (Cylinder): −0.75 D to −1.75 D 7.3 Axis: 10°, 20°, 30°, 70°, 80°, 90°, 100°, 110°, 150°, 160°, 170°, 180° 7.4 Near Addition: +0.75 D to +2.50 D 8. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule |
| Key exclusion criteria | 1. 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 investigatorMonocular participants (only one eye with functional vision) or participants fit with only one lens 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 investigator or his/her staff, 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 | 17/07/2026 |
| Date of final enrolment | 30/08/2026 |
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
15/07/2026: Study's existence confirmed by Health Research Authority (HRA) (UK).
