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About
This study is a randomized, 4-visit, double-masked, 2x3 bilateral crossover, dispensing trial. The study lenses will be worn as daily wear (DW) for a period of two weeks each with one of the study lenses being worn twice. Each study lens is expected to be worn at least five (5) days per week for at least six (6) hours per day worn. There will be no washout period between study lenses.
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Inclusion and exclusion criteria
Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
Appear able and willing to adhere to the instructions set forth in this clinical protocol.
Healthy adult males or females age ≥18 years of age with signed informed consent.
Eligible presbyopes will be those that wear full distance contact lenses in both eyes, then wear reading glasses over them.
The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of DW per day, at least 5 days per week, for a minimum of 1 month prior to the study) and willing to wear the study lenses on a similar basis.
Subjects must be able and willing to wear the study lenses at least 6 hours a day, a minimum of 5 days per week.
The subject's vertex-corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 (inclusive) in each eye.
The subject's refractive cylinder must be ≤ -1.00 D in each eye.
Have spherocylindrical best corrected visual acuity of 20/25+3 or better in each eye.
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
Primary purpose
Allocation
Interventional model
Masking
92 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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