Presbyopia and astigmatism Eye Diseases Presbyopia, Astigmatism
Conditions
Sponsors
CooperVision International Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: There are no requirements as to participant race or gender. In order to be enrolled, each participant shall meet the following criteria: 1. 40 or more years of age 2. Current multifocal contact lens wearer 3. Spectacle refraction: Distance: Sphere: -6.00 D to + 4.00 D Astigmatism Power: -0.50 D to -1.25 D Axis; 180o ± 20o & 90o ± 20o Near addition: at 40 cm: +0.75 D to +2.50 D in three groups: - Emerging presbyopes: +0.75 D to +1.25 D - Established presbyopes: +1.50 D and +1.75 D - Advanced presbyopes: +2.00 D to +2.50 D 4. Best corrected visual acuity of at least 20/25 in each eye
Exclusion criteria
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 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 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 |
|---|---|
| Visual satisfaction measured on a 100-point visual analogue scale after 1 week of wear | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Visual performance measured using LogMAR at distance, intermediate and near and monocularly after 1 week of wear 2. Lens centration measured using a 4-point forced-choice scale at Visits 3 and 4 3. Lens movement measured using a 5-point forced-choice scale at Visits 3 and 4 4. Intention to purchase measured using a 5-point forced-choice scale at Visits 3 and 4 5. Overall preference measured using a forced-choice scale with two alternatives at Visits 3 and 4 | — |
Countries
England, United Kingdom
Contacts
Public ContactDeborah Moore
Outcome results
None listed