Evaluation of a Multi-Purpose Solution
|ClinicalTrials.gov Identifier: NCT00710879|
Recruitment Status : Completed
First Posted : July 8, 2008
Results First Posted : February 8, 2011
Last Update Posted : December 13, 2011
|Condition or disease||Intervention/treatment||Phase|
|Contact Lens Solutions||Device: Bausch & Lomb Multi-Purpose Solution||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Study to Evaluate the Clinical Performance of a Multi-Purpose Solution.|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||February 2009|
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.
- Antimicrobial Efficacy [ Time Frame: 2 weeks, 3 months ]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
- Solution Related AE's and Lens Changes [ Time Frame: 3 months, 6 months ]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 ]The Utility was determined based on the results of the efficacy and safety evaluations.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00710879
|United States, California|
|Dr. Nicholas Marsico|
|Torrance, California, United States, 90505|
|Study Director:||Bev Barna||Bausch & Lomb Incorporated|