Presbyopia Eye Diseases
Conditions
Interventions
The participant will wear in turn the two study contact lenses (Biofinity® Multifocal and MyDay® Multifocal) for 2 weeks as their vision correction modality. The participants will attend the clinic fo
Sponsors
Coopervision International Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 40 years and older 2. Current multifocal contact lens wearer (other than MyDay® multifocal but can include Biofinity® multifocal) 3. Spectacle refraction: Distance: Sphere: -6.00D to + 4.00D Astigmatism: 0.00D to -0.75D Near Addition: +0.75D to +2.50D 4. Best corrected visual acuity of at least 20/25 in each eye 5. The prospective participants will be given a Participant Information Sheet to read and an Informed Consent Form to sign prior to any evaluation.
Exclusion criteria
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 13. Current wearer of the test contact lens MyDay® multifocal contact lens
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ease of handling over the week preceding the follow-up visit, measured using subjective ratings and satisfaction questionnaires during the follow-up visits | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual acuity, measured using logMAR visual acuity recorded during the follow-up visits | — |
Countries
England, United Kingdom
Contacts
Public ContactDeborah Moore
Outcome results
None listed