Presbyopia
Conditions
Brief summary
The purpose of this study is to measure the logMAR visual acuity when presbyopic soft lens wearers are fit with Dailies Total1 Multifocal and ACUVUE OASYS MAX 1-DAY Multifocal.
Interventions
DEVICEDeleficon A (multifocal)
Daily disposable silicone hydrogel contact lenses indicated for presbyopia, in addition to myopia or hyperopia.
DEVICESenofilcon A (multifocal)
Daily disposable silicone hydrogel contact lenses indicated for presbyopia, in addition to myopia or hyperopia
Sponsors
Alcon Research
University of Waterloo
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
42 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Are at least 42 years of age and has full legal capacity to volunteer; 2. Have signed an information consent letter; 3. Are willing and able to follow instructions and maintain the appointment schedule; 4. Habitually wears soft contact lenses for the past 3 months (minimum); 5. Are presbyopic and require a reading addition of at least +0.75D and no more than +1.75D; 6. Can be refracted and achieve monocular spectacle distance vision of at least 20/25 Snellen (or +0.10logMAR) visual acuity; 7. Have contact lens power requirements that fall within the available study lens parameters (distance sphere: +6D to -9D; near addition as per each lens design); 8. Can be fit with the initial fitting guidelines provided by the lens manufacturer and use either Low or Medium Add (same add in both eyes).
Exclusion criteria
1. Are a current habitual wearer of Dailies Total1 Multifocal or ACUVUE OASYS MAX 1-DAY Multifocal; 2. Has refractive astigmatism higher than -0.75DC in either eye; 3. Are participating in any concurrent clinical or research study involving intervention or invasive ocular tests; 4. Have any known active ocular disease and/or infection; 5. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; 6. Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; 7. Have known sensitivity to the diagnostic pharmaceuticals to be used in the study; 8. Have undergone refractive error surgery; 9. Are a member of the Centre for Ocular Research & Education (CORE) directly involved in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| High contrast visual acuity (logMAR) at 6m | Day 1 | High contrast visual acuity (logMAR) for the dominant eye under photopic illumination at 6m |
| High contrast visual acuity (logMAR) at 40cm | Day 1 | High contrast visual acuity (logMAR) for the dominant eye under photopic illumination at 40cm |
Countries
Canada
Outcome results
None listed