Presbyopia Eye Diseases Presbyopia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. At least 40 years old 2. Have read and understood the Participant Information Sheet 3. Have read, signed and dated the Informed 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 multifocal contact lens wearer 7. Spectacle refraction: 8. Distance: Sphere: -6.00D to + 4.00D, Astigmatism: 0.00D to -0.75D 9. Near Addition: +0.75D to +2.50D in three groups: 9.1. Emerging presbyopes: +0.75D to +1.25D 9.2. Established presbyopes:+1.50D and +1.75D 9.3. Advanced presbyopes: +2.00D to +2.50D 10. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule
Exclusion criteria
Exclusion criteria: 1. Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear 2. Use of systemic or ocular medications for which contact lens wear could be contraindicates as determined by the investigator 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective assessment of overall visual satisfaction, measured using a 100-point Visual Analog Scale (VAS) at the dispensing visit and follow-up visit for each of the lens types | — |
Secondary
| Measure | Time frame |
|---|---|
| Binocular visual performance, measured using high and low contrast LogMAR visual acuity charts at distance (4m), intermediate (67cm) and near (40cm) under high, medium and low levels of illumination, at the follow-up visit for each lens type | — |
Countries
United Kingdom