This study evaluates a multi-purpose solution when used on a daily wear basis by currently adapted soft contact lens wearers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
180
Daily care for contact lenses.
Dr. Nicholas Marsico
Torrance, California, United States
Antimicrobial Efficacy
Excellent = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora \<0-103 CFU/mL. Good = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora \<103-105 CFU/mL. Skeptical = Bacterial infection suspected and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. No Efficacy = Bacterial infection definite and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. Pathogens were H. aegyptius, H. influenzae, Moraxella spp., P. aeruginosa, S. pneumoniae, S. aureus, N. gonorrhoeae
Time frame: 2 weeks, 3 months
Solution Related AE's and Lens Changes
Very Safe = No solution related AEs and no changes in lens properties related to the solution. Safe = No solution related AEs and slight change in lens properties related to the solution, but lens wear was continued. Skeptical = Solution related AEs were suspected and lens properties changed due to the solution and lens wear was discontinued. Not Safe = Solution related AEs were present and lens properties changed due to the solution and lens wear was discontinued.
Time frame: 3 months, 6 months
Solution Utlility
The Utility was determined based on the results of the efficacy and safety evaluations.
Time frame: 3 months, 6 months
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