Evaluation of a Multi-Purpose Solution
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|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|
|Contact Lens Solutions||Device: Bausch & Lomb Multi-Purpose Solution|
|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|
|Primary Completion Date :||February 2009|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|