Evaluation of a Multi-Purpose Solution
This study has been completed.
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
First received: June 30, 2008
Last updated: December 7, 2011
Last verified: December 2011
This study evaluates a multi-purpose solution when used on a daily wear basis by currently adapted soft contact lens wearers.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Study to Evaluate the Clinical Performance of a Multi-Purpose Solution.|
Resource links provided by NLM:
Further study details as provided by Bausch & Lomb Incorporated:
Primary Outcome Measures:
- Antimicrobial Efficacy [ Time Frame: 2 weeks, 3 months ] [ Designated as safety issue: No ]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
Secondary Outcome Measures:
- Solution Related AE's and Lens Changes [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: Yes ]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.
- Solution Utlility [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]The Utility was determined based on the results of the efficacy and safety evaluations.
|Study Start Date:||July 2008|
|Study Completion Date:||February 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
Experimental: Multipurpose Solution
Multi-purpose solution administered to adapted FDA group I soft contact lens wearers and FDA group IV soft contact lens wearers.
Device: Bausch & Lomb Multi-Purpose Solution
Daily care for contact lenses.
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