Presbyopia Eye Diseases
Conditions
Interventions
Randomisation is carried out by a standard computer randomisation generator software. Two types of contact lenses will be worn by each participant in a random order in turn for approximately one week
Sponsors
Brien Holden Vision Institute
Eligibility
Sex/Gender
All
Age
40 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. 40 or more years of age 2. Current multifocal contact lens wearer 3. Spectacle refraction: 3.1. Distance: Sphere: -5.00D to + 3.00D 3.2. Astigmatism: 0.00 to -0.75D 3.3. Near Spectacle Addition at 40cm 3.4. Medium add presbyopes: +1.50D and +1.75D 3.5. High add presbyopes: +2.00D to +2.50D 4. Best corrected visual acuity of at least 20/25 in each eye 5. Participant has read and understood the Participant Information Sheet 6. Participant has read, signed and dated the Informed Consent 7. Participant willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule
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 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 control contact lenses, MyDay® Multifocal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall binocular vision satisfaction measured using a 0-100point Visual Analogue Scale (VAS) with anchor descriptors of 0 = Extremely Unsatisfied and 100 = Extremely satisfied, after 1 week of contact lens wear | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean binocular visual acuity, measured as the mean visual acuity of overall distance and overall near visual acuities, after 1 week of contact lens wear | — |
Countries
England, United Kingdom
Contacts
Public ContactDeborah Moore
Outcome results
None listed