Presbyopia
Conditions
Brief summary
This study will compare the performance of two daily disposable multifocal soft contact lenses.
Detailed description
This is a double-masked, randomized, crossover, 1-week, real world dispensing study, where participants will wear two designs of daily disposable soft multifocal contact lenses for 5-7 days each.
Interventions
DEVICELens A (kalfilcon A)
Daily disposable, soft contact lenses worn for one week
DEVICELens B (stenfilcon A)
Daily disposable, soft contact lenses worn for one week
Sponsors
CooperVision International Limited (CVIL)
University of California, Berkeley
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. They are at least 18 years of age. 2. They understand their rights as a research participant and are willing and able to sign a Statement of Informed Consent. 3. They habitually use soft contact lenses (multifocal soft contact lenses, sphere lenses for monovision, or sphere lenses for distance vision correction and spectacles for near vision correction,) and have worn lenses at least 3 days a week for at least the past six months. 4. They have a minimum reading add of +0.75DS (based on their spectacle refraction) 5. They have spherical equivalent refractive error between +6.00 to -10.00DS at the corneal plane and refractive astigmatism of no greater than -0.75DC in each eye. 6. They are able to achieve distance HCHL visual acuity of +0.10 logMAR or better in each eye.
Exclusion criteria
1. They have an ocular disorder which would normally contra-indicate contact lens wear. 2. They have a systemic disorder which would normally contra-indicate contact lens wear. 3. They are aphakic. 4. They have had corneal refractive surgery. 5. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Visual Acuity | Through study completion, approximately 4 hours | High contrast high luminance (HCHL) distance binocular visual acuity (logMAR) |
Countries
United States
Contacts
CONTACTJose A Vega, OD,MSc,PhD
PRINCIPAL_INVESTIGATORMeng C Lin
University of Berkeley
Outcome results
None listed