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Evaluation of a Multi-Purpose Solution

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00710879
First received: June 30, 2008
Last updated: December 7, 2011
Last verified: December 2011
History of Changes

June 30, 2008
December 7, 2011
July 2008
February 2009   (final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT00710879 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
Evaluation of a Multi-Purpose Solution
A Study to Evaluate the Clinical Performance of a Multi-Purpose Solution.

This study evaluates a multi-purpose solution when used on a daily wear basis by currently adapted soft contact lens wearers.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Contact Lens Solutions
Device: Bausch & Lomb Multi-Purpose Solution
Daily care for contact lenses.
Experimental: Multipurpose Solution
Multi-purpose solution administered to adapted FDA group I soft contact lens wearers and FDA group IV soft contact lens wearers.
Intervention: Device: Bausch & Lomb Multi-Purpose Solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
February 2009
February 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Is an adapted Group I or Group IV soft contact lens wearer and agrees to wear the study lenses on a daily wear basis.
  • Must be able and willing to comply with all treatment and follow-up study procedures.
  • Must have a clear central cornea.
  • VA correctable to 0.3 LogMar or better (driving vision)

Exclusion Criteria:

  • Systemic disease affecting ocular health.
  • Using systemic or topical medications.
  • Wear monovision, multifocal or toric contact lenses.
  • Any grade 2 or greater slit lamp findings.
  • Pregnancy
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00710879
568
No
Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
Not Provided
Study Director: Bev Barna Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP