This is a multi-site, dispensing, 4-visit, 2-arm parallel group, randomized, double-masked clinical trial using a Vistakon investigational contact lens (test) and a marketed monthly replacement contact lens (control). Each subject will be assigned randomly to either the test or control lens to evaluate the long term safety and efficacy of the investigational contact lens compared to the marketed contact lens over a period of six months of lens wear.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
105
Vue Optical Boutique
Jacksonville, Florida, United States
Omega Vision Center, PA / Sabal Eye Care
Longwood, Florida, United States
Eyecare Associates
Bloomington, Illinois, United States
Dr. Debbie H. Kim, OD
Closter, New Jersey, United States
Proportion of Eyes Grade 3 or Higher SLF
Slit lamp findings were graded using a FDA Grade Scale, 0 = None, 1 = Slight, 2 = Moderate, 3 = Significant, 4 = Advanced. Measurements were taken in each subject eye at the initial visit, 4 month, 5 month and 6 month follow-up evaluations. This study is a continuation of a previous study therefore data from the initial visit was included in reporting. The proportion of subject eyes with SLF grade 3 or higher was reported for each lens.
Time frame: Up to 6 Month Follow-up
Visual Acuity (logMAR)
The visual acuity (LogMAR) was collected at the initial visit, 4 month, 5 month and 6 month follow-up evaluations. This study is a continuation of a previous study therefore data from the initial visit was included in reporting. The average Visual Acuity (logMAR) across the 4 study visits and at each individual visit was reported for each lens.
Time frame: Up to 6 Month Follow-up
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Sacco Eye Group
Vestal, New York, United States
Dr. William Bogus
Salt Lake City, Utah, United States