This study is a 4-visit, multi-site, prospective, controlled, randomized, single-masked (subjects), two-arm parallel group, bilateral, dispensing clinical trial to compare the performance of the Test lens to the Control lens in terms of safety and efficacy.
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.
Be at least 40 years of age and not greater than 70 years of age at the time of consent.
Own a wearable pair of spectacles if required for their distance vision.
None
Parallel
Senofilcon A
DeviceACUVUE® Oasys MAX 1-Day Multifocal
Nelfilcon A
DeviceDAILIES® AquaComfort Plus® Multifocal
Mean binocular HLHC distance Visual Acuity
Mean binocular HLHC VA at distance (4m)
Mean binocular HLHC Intermediate Visual Acuity
Mean binocular HLHC VA at Intermediate (64cm)
Mean binocular HLHC Near Visual Acuity
Mean binocular HLHC VA at Near (40cm)
Incidence rate of study-lens related (i.e. related and possibly related) ocular adverse events.
Mean binocular HLHC distance Visual Acuity
Mean binocular HLHC VA at distance (4m)
Mean binocular HLHC Intermediate Visual Acuity
Mean binocular HLHC VA at Intermediate (64cm)
Mean binocular HLHC Near Visual Acuity
Mean binocular HLHC VA at Near (40cm)
Incidence rate of Slit Lamp Findings (SLF)
Slit lamp findings will be assessed for each eye at all study visits (scheduled and unscheduled) by grade. SLFs will be evaluated and graded using the ISO 11980 Grading scale from 0 to 4, where Grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e., Grade 1 = trace, Grade 2 = mild, Grade 3 = moderate and Grade 4 = severe).
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