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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
ACUVUE® Oasys MAX 1-Day Multifocal
DAILIES® AquaComfort Plus® Multifocal
Pearson Research Center PA
Longwood, Florida, United States
VisualEyes
Roswell, Georgia, United States
The Koetting Associates
St Louis, Missouri, United States
Mean binocular HLHC distance Visual Acuity
Mean binocular HLHC VA at distance (4m)
Time frame: At 1-week follow-up
Mean binocular HLHC Intermediate Visual Acuity
Mean binocular HLHC VA at Intermediate (64cm)
Time frame: At 1-week follow-up
Mean binocular HLHC Near Visual Acuity
Mean binocular HLHC VA at Near (40cm)
Time frame: At 1-week follow-up
Incidence rate of study-lens related (i.e. related and possibly related) ocular adverse events.
Time frame: Up to 1-month follow-up
Mean binocular HLHC distance Visual Acuity
Mean binocular HLHC VA at distance (4m)
Time frame: At 1-month follow-up
Mean binocular HLHC Intermediate Visual Acuity
Mean binocular HLHC VA at Intermediate (64cm)
Time frame: At 1-month follow-up
Mean binocular HLHC Near Visual Acuity
Mean binocular HLHC VA at Near (40cm)
Time frame: At 1-month follow-up
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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Spectrum Eyecare
Jamestown, New York, United States
Center for Ophthalmic and Vision Research/Eye Associates of New York
Manhattan, New York, United States
Sacco Eye Group
Vestal, New York, United States
Dr. David W. Ferris & Associates
Warwick, Rhode Island, United States
Total Eye Care
Memphis, Tennessee, United States
Paradigm Research Center, LLC
Houston, Texas, United States
Tyler Eye Associates
Tyler, Texas, United States
...and 1 more locations
Time frame: Up to 1-month follow-up