The objective of this study is to evaluate the safety and effectiveness of ASP-57 Multi-Purpose contact lens solution (Test) compared to ReNu® Multiplus Contact Lens Solution (Control) when used by habitual contact lens wearers to bilaterally clean and disinfect their contact lenses for approximately 3 months (12 weeks).
Approximately 330 subjects (660 eyes) will be enrolled in this 3 month (12 week) controlled, parallel group, masked, randomized study at approximately 15 investigative sites in the United States. Subjects will be randomized 2:1 to receive either Asepticys ASP-57 Multi-Purpose Solution or ReNu® Multiplus Contact Lens Solution (Control) respectively. Both Test and Control solution will be used with a rub care regimen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
315
an experimental solution for disinfecting, cleaning, conditioning, rinsing, protein removal, ad storing soft contact lenses including silicone hydrogel lenses
a multi-purpose solution for disinfecting, cleaning, conditioning, rinsing, protein removal, ad storing soft contact lenses including silicone hydrogel lenses
Lakeside Vision Center
Irvine, California, United States
Complete Family Vision Care
San Diego, California, United States
Sabal Eye Care
Longwood, Florida, United States
Slit Lamp Findings
Statistical non-inferiority with respect to the proportion of eyes with any slit-lamp findings greater than Grade 2 at any visit between the test and control solutions
Time frame: 3 months
Visual Acuity
Statistical non-inferiority with respect to the proportion of subjects with greater than 2-line worsening in visual acuity in any eye at any visit between the test and control solutions
Time frame: 3 months
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Maitland Vision Center
Maitland, Florida, United States
Vision Health Institute
Orlando, Florida, United States
Eye Care Associates
Bloomington, Illinois, United States
Kannarr Eye Care
Pittsburg, Kansas, United States
Heart of America Eye Care
Shawnee Mission, Kansas, United States
Seidenberg Protzko Eye Associates
Havre de Grace, Maryland, United States
Insight Eyecare
Warrensburg, Missouri, United States
...and 4 more locations