Hyperopia, Myopia, Presbyopia
Conditions
Brief summary
The aim of this study is to compare the overall lens satisfaction between two soft multifocal contact lenses.
Detailed description
The aim of the study is to evaluate the overall lens satisfaction between two soft multifocal contact lenses when compared to each other after 15 minutes of daily wear each.
Interventions
DEVICELow ADD power somofilcon A lens
Participants will be randomized to wear low ADD power somofilcon A lens for 15 minutes.
DEVICEMedium ADD power somofilcon A lens
Participants will be randomized to wear medium ADD power somofilcon A lens for 15 minutes.
DEVICEHigh ADD power somofilcon A lens
Participants will be randomized to wear high ADD power somofilcon A lens for 15 minutes.
DEVICEomafilcon A lens
Participants will be randomized to wear omafilcon A lens for 15 minutes.
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 subject 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, sphere lenses for distance vision correction and spectacles for near vision correction,) and have done so for at least the past three 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 HCVA 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 |
|---|---|---|
| Overall lens satisfaction | At the end of 15 minutes wear | Overall Impression recorded on a visual analog scale of 0 to 100 where (0=Extremely poor. Unmanageable. Cannot use lenses, 100=Excellent. Highly impressed with these lenses overall.) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMeng C Lin, OD, Ph.D
UC Berkeley
Outcome results
None listed