To compare the safety and efficacy of the CVI silicone-hydrogel lens worn on an extended wear basis for a period of up to 7 days and 6 nights with the Acuvue 2 soft contact lenses.
To compare the safety and efficacy of the CVI silicone-hydrogel lens worn on an extended wear basis for a period of up to 7 days and 6 nights with the Acuvue 2 soft contact lenses in this open-labeled randomized study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
460
Test device
Control device
La Mesa Vision Care Center
La Mesa, California, United States
Frequency of serious and significant AEs
Frequency of serious and significant AEs defined as a composite of infiltrates of higher than grade 2 and/or infiltrates with any overlying staining, peripheral ulcer, and loss of two or more lines of visual acuity at any time during the trial
Time frame: 1 Year
Contact Lens Visual Acuity
Contact lens visual acuity was assessed using LogMAR
Time frame: 1 Year
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