The purpose of this study is to evaluate on-eye clinical performance of the investigational contact lenses following 30 days of wear in the intended population.
Subjects will wear two different contact lens study products in a cross-over fashion. Each study product type will be worn for approximately 30 days. A washout period of 2-4 days will occur prior to the first wear period and between the two wear periods. Subjects will be expected to attend 5 office visits. The total duration of study participation is approximately 66 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
95
Investigational multifocal contact lenses for astigmatism
Commercially available multifocal contact lenses for astigmatism
Hydrogen peroxide-based contact lens cleaning and disinfection system
Dr.Elsa Pao, O.D
Oakland, California, United States
Pacific Rims Optometry
San Francisco, California, United States
Drs. Giedd, P.A.
Maitland, Florida, United States
Mean Binocular Visual Acuity at Distance (4 Meters) at Day 30 With Study Lenses
Visual Acuity (VA) was assessed at a distance of 4 meters with both eyes together (binocular) under high contrast, high illumination lighting with study lenses in place. VA was measured using letter charts and recorded in the logarithm of the minimum angle of resolution (LogMAR). A LogMAR value of 0 equates to 20/20 Snellen VA (normal distance eyesight), with negative LogMAR values representing better than 20/20 VA. The LogMAR VA scale ranges from -0.30 (20/10 Snellen) to 1.00 (20/200 Snellen).
Time frame: Day 30 (-2/+1) of each wear period. A wear period was 30 days (-2/+1) according to randomization assignment.
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Investigational multifocal contact lenses for astigmatism
Hydrogen peroxide-based contact lens cleaning and disinfection system
Vision Health Institute
Orlando, Florida, United States
Kannarr Eye Care LLC
Pittsburg, Kansas, United States
Wesley Optometric Consulting
Medina, Minnesota, United States
Oculus Research, Inc.
Garner, North Carolina, United States
ProCare Vision Centers, Inc.
Granville, Ohio, United States
Insight Research Clinic LLC
Powell, Ohio, United States
Optometry Group, PLLC
Memphis, Tennessee, United States
...and 1 more locations