Rationale for Choice of Control Product Sample Clauses

Rationale for Choice of Control Product. DT1 contact lenses were chosen as the control product because this lens is a proper predicate device to compare to DD T2 in regards to effectiveness and safety. Both DD T2 and DT1 are silicone hydrogel lenses and are to be prescribed for single use, daily disposable wear. The DT1 spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
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Rationale for Choice of Control Product. The Biofinity contact lens was chosen as the control product because this lens is a proper device to compare to contact lens with regard to effectiveness and safety. Both the contact lens and Biofinity contact lens are frequent replacement SiHy lenses and are to be prescribed for daily wear. The Biofinity contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes. The lenses are intended to be cleaned and disinfected daily when worn for daily wear and replaced monthly.
Rationale for Choice of Control Product. Clariti 1-Day contact lenses were chosen as the control product because these lenses have the same wear modality and replacement schedule.
Rationale for Choice of Control Product. The control product, DACP, was chosen to compare the effects of a spherical design versus the aspherical low plus design of the test product and to avoid any confounding factors related to lens material.
Rationale for Choice of Control Product. DACP lenses were chosen as the control product to address the study objectives. DACP contact lenses were chosen as the control product because these lenses have the same wear modality, material, and parameters to the test product DACP Digital, and are the spherical design as compared to the test product’s aspherical design.

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